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# IPQ.org

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## Posts

- [Archives](https://ipq.org/archives/)
- [IPQ Quarterly Update – January - March 2026 in Review](https://ipq.org/ipq-quarterly-update-january-march-2026-in-review/) - The feature story in this IPQ January-March issue focuses on the valuable insights offered by leading experts at the 2026 CASSS WCBP conference on how appropriately structured CMC submissions can enable cross-agency data comparability and shared analytics, drive streamlined marketing authorization and PAC assessments, and expand the potential for regulatory collaboration and reliance. They explained where the current CMC regulatory challenges lie and what is being done through ICH M4Q(R2) and M16 to address them. Included is the substantive discussion that followed at the session and a bibliography highlighting the wealth of coverage IPQ has provided since 2010 on the progress of this international collaboration journey.
- [Role of ICH M4Q and M16 In Modernizing the CMC Regulatory Process Explored at 2026 CASSS WCBP Symposium](https://ipq.org/role-of-ich-m4q-and-m16-in-modernizing-the-cmc-regulatory-process-explored-by-key-experts-at-2026-casss-wcbp-symposium/) - The role of ICH M4Q and M16 in creating a more efficient, effective and globally aligned CMC regulatory process that can help release the potential of digitization and advanced data management technologies including artificial intelligence (AI) drew active dialogue from key thought leaders at the concluding session of the 2026 CASSS Well Characterized Biotechnology Product (WCBP) Symposium, which took place in Washington, DC in late January.
- [IPQ Monthly Update – December 2025 in Review](https://ipq.org/ipq-monthly-update-december-2025-in-review/) - The feature story in this monthly issue focuses on the ideas offered by EFPIA’s biomanufacturing team members at the October 2025 CASSS CMC Strategy Forum Europe for streamlining and harmonizing the CMC expectations in Europe and globally – in particular, for: ● ADCs ● the use of platform approaches and drug master files ● polysorbate control ● manufacturing site technology transfer, and ● subcutaneous formulations. Also highlighted in the story is the comprehensive 22-page position paper on “Science and Risk-based Approaches for the Classification of Post-approval Changes (PACs) for Advanced Therapy Medicinal Products (ATMPs) in the EU,” which EFPIA published in December.
- [EFPIA’s Biomanufacturing Agenda is Targeting Increased Risk-based Regulatory Flexibility](https://ipq.org/efpias-biomanufacturing-agenda-is-targeting-increased-risk-based-regulatory-flexibility/) - The biomanufacturing wing of the European Federation of Pharmaceutical Industries and Associations (EFPIA) Manufacturing & Quality Expert Group (MQEG) is heavily focused on how to gain more leverage from platform technologies, prior knowledge and risk-based tools in streamlining and harmonizing the regulatory expectations for assessing comparability, specification conformance, and lifecycle management for the expanding universe of biotech products. The issues involved in adapting regulatory processes to make them more innovation supportive across the development and manufacturing spectrum for advanced biotech therapies and vaccines were in focus at the EFPIA satellite session that preceded the October 2025 CASSS Europe CMC Strategy Forum, held in Basel, Switzerland. At the session, representatives from the biomanufacturing team provided status updates, shared data, and outlined emerging concepts and proposals from the team’s ongoing activities.
- [IPQ Monthly Update June 2025](https://ipq.org/june2025/) - Table of Contents Summary of the Contents Click images to enlarge .
- [IPQ Monthly Update – November 2025 in Review](https://ipq.org/ipq-monthly-update-november-2025-in-review/) - The feature story in IPQ’s Monthly Update for November (see pp. 4-36) focuses on insights from two prominent FDA inspection experts on why data integrity (DI) failures continue to surface across the product life cycle and how to build more resilient governance systems that prevent them. In a DI-focused session at the 2025 PDA Regulatory Conference, industry consultant Peter Baker, a former FDA investigator with broad international experience, and CDER veteran compliance official Carmelo Rosa reflected on their deep engagement with data management across pharmaceutical manufacturing operations and the quality and regulatory consequences that ensue when data handling systems are inadequate.
- [FDA Inspection Experts Explore the Continuing Problem of Data Integrity and where Solutions Lie](https://ipq.org/fda-inspection-experts-explore-the-continuing-problem-of-data-integrity-and-where-solutions-lie/) - At the September 2025 PDA Regulatory Conference held in Washington, DC, two prominent experts on FDA inspections examined why data integrity (DI) failures continue to surface across the product life cycle and what it will take to build more resilient governance systems that prevent them. The second-day plenary session on ‘Data Integrity at the Next Level’ provided the opportunity for Live Oak Quality Assurance President and former FDA investigator Peter Baker and CDER Office of Compliance (OC) Division of Drug Quality I Director Carmelo Rosa to share their complementary perspectives. The presentations were followed by an extended Q&A, moderated by industry consultant Sue Schniepp.
- [IPQ Monthly Update – September/October 2025 in Review](https://ipq.org/ipq-monthly-update-september-october-2025-in-review/) - The five stories in the September/October 2025 Monthly Update provide a deep dive into the issues that have been on the front burner in FDA’s recent efforts to assure the quality of drugs, biologics, and vet medicines. In focus is the light shed on them by agency compliance and inspection leaders at the September PDA Regulatory Conference.
- [Week Ending October 31, 2025: Featuring a Panel of FDA Compliance Leaders Discussing Key Current Concerns](https://ipq.org/week-ending-october-31-2025-featuring-a-panel-of-fda-compliance-leaders-discussing-key-current-concerns/) - Following individual updates by compliance leaders from FDA’s centers for drugs, biologics, and veterinary medicine and the new cross-center inspection office at the closing day plenary session of the September, 2025 PDA Regulatory Conference, they participated together in a panel discussion that further explored some of the key operational and policy concerns impacting the agency’s evolving oversight model. Receiving attention were: ● the center/field reorganization ● artificial intelligence (AI) ● pre-approval inspections (PAIs) ● inspection site selection models ● unannounced foreign inspections ● xenotransplantation animals ● warning letter trends, and ● the rise in vet drug enforcement actions.
- [Weeks Ending October 17 & 24, 2025: Featuring CBER, CDER, CVM and OII Compliance Updates](https://ipq.org/weeks-ending-october-17-24-2025-featuring-cber-cder-cvm-and-oii-compliance-updates/) - In the morning plenary session on the concluding day of the September 2025 PDA Regulatory Conference, CBER, CDER and CVM compliance office leaders and the acting director of the Office of Human and Animal Drug Inspectorate (OHADI) shed light on the current regulatory processes, priorities and enforcement outlook across their respective programs.
- [Weeks Ending October 3 & 10, 2025: Featuring FDA Compliance and Inspection Leaders on the Current Enforcement Landscape](https://ipq.org/weeks-ending-october-3-10-2025-featuring-fda-compliance-and-inspection-leaders-on-the-current-enforcement-landscape/) - At the opening session of the 2025 PDA Regulatory Conference, a panel of senior FDA compliance leaders from CDER, CBER, CVM, and the Office of Inspections and Investigations (OII) explored the current inspection and compliance landscape – from the impact of FDA’s center/field reorganization to the evolving approaches for applying risk-based oversight and improving transparency and supply-chain quality.
- [Weeks Ending September 19 & 26, 2025: Featuring FDA's Swoboda on CBER Compliance Trends and Center/Field Reorganization](https://ipq.org/weeks-ending-september-19-26-2025-featuring-fdas-swoboda-on-cber-compliance-trends-and-center-field-reorganization/) - At the opening plenary session of the September 2025 PDA Regulatory Conference, CBER Office of Compliance and Biologics Quality Consumer Safety Officer Jonathan Swoboda provided an update on CBER’s: ● compliance actions and product focus ● warning letter recipients and top cGMP citations during FY2025 ● recall activity, and ● center/field reorganization.
- [Weeks Ending September 5 & 12, 2025: Featuring FDA’s Godwin on Recent Drug GMP Trends and Enforcement Activities](https://ipq.org/weeks-ending-september-5-12-2025-featuring-fdas-godwin-on-recent-drug-gmp-trends-and-enforcement-activities/) - At the opening plenary session of the September 2025 PDA Regulatory Conference, FDA CDER Office of Manufacturing Quality [OMQ] Director Francis Godwin provided an update on GMP trends and recent enforcement activities. His presentation covered: ● an introduction to OMQ ● FY 2025 activities ● intravenous fluid shortages ● APIs for pharmacy compounding and related quality oversight, and ● a “chamber of horrors” case study.
- [IPQ Monthly Update – August 2025 in Review](https://ipq.org/ipq-monthly-update-august-2025-in-review/) - The four stories in the August Monthly Update are centered around the dialogue that took place between regulators and industry at the mid-July CASSS CMC Strategy Forum on bioconjugates and multispecifics. In the IPQ coverage, experienced regulators and former regulators from Canada, Japan, Chile and FDA weigh in on the CMC issues that are presenting themselves in interfacing with sponsors and how they are being addressed. A common theme was the benefits of early engagement to help smooth out the development and clearance process, and the importance of international convergence to make the process – given the complexities involved – more manageable for all involved.
- [Week Ending August 29, 2025: Featuring Regulatory Panel Discussion of Bioconjugate and Multispecific CMC Challenges](https://ipq.org/week-ending-august-29-2025-featuring-regulatory-panel-discussion-of-bioconjugate-and-multispecific-cmc-challenges/) - At the regulatory session of the Summer 2025 CASSS CMC Strategy Forum on bioconjugates and multispecifics, a panel that included current and former regulators from different countries explored the characterization, potency assessment, and manufacturing challenges created by the design diversity and structural complexity of these products, and strategies for addressing the challenges and gaining agency clearance.
- [Former FDA Regulators Shapiro and Duncan Weigh In on the CMC Challenges of Bioconjugates and Multispecifics at CASSS Forum](https://ipq.org/former-fda-regulators-shapiro-and-duncan-weigh-in-on-the-cmc-challenges-of-bioconjugates-and-multispecifics-at-casss-forum/) - Complementing the perspectives offered by regulators from Canada, Japan and Chile at the CASSS Summer CMC Strategy Forum on bioconjugates and multispecifics were presentations by former FDA reviewers Marjorie Shapiro and Katherine Duncan, who drew on their extensive regulatory experience and learnings in discussing the CMC challenges that these products present and the pathway forward in addressing them.
- [Weeks Ending August 15 & 22, 2025: Featuring Japan and Chile Regulators on the Evolving Bioconjugate/Multispecific Landscape](https://ipq.org/weeks-ending-august-15-22-2025-featuring-japan-and-chile-regulators-on-the-evolving-bioconjugate-multispecific-landscape/) - In a session on regulatory considerations at the Summer 2025 CASSS CMC Strategy Forum North America on bioconjugates and multispecifics, held in Gaithersburg, MD, in mid-July, regulators from Japan and Chile reviewed the experience of their respective agencies in this expanding product field and how approaches are evolving in the context of internal capabilities and international developments.
- [Weeks Ending August 1 & 8, 2025: Featuring Health Canada's Yeung at CASSS Bioconjugate/Multispecific Forum](https://ipq.org/weeks-ending-august-1-8-2025-featuring-featuring-health-canadas-yeung-at-casss-bioconjugate-multispecific-forum/) - At the opening session of the Summer 2025 CASSS CMC Strategy Forum North America on novel bioconjugates and multispecifics, Health Canada Biologic and Radiopharmaceutical Drugs Directorate Senior Biologist/Evaluator Angela Yeung reviewed how the agency is addressing the regulatory challenges posed by novel antibody-based constructs. Her presentation covered: ● Health Canada’s review process for bioconjugates and multispecifics ● CMC considerations, and ● case studies from recent submissions.
- [IPQ Monthly Update – July 2025 in Review](https://ipq.org/ipq-monthly-update-july-2025-in-review/) - The three stories in the July Monthly Update (see pp. 4-45) provide insights from leading regulators on the CMC regulatory issues and developments for cell and gene therapies (CGTs). The first two focus on a regulatory session that concluded the June CASSS CGT conference, at which a panel of international regulatory leaders shed light on the strategies their respective agencies are pursuing to support the rapidly evolving CGT field and how these connect with broader regional and global convergence efforts. The third move to a June PDA Europe ATMP Conference, where EMA’s Dolça Rogers shared case studies elucidating two of the significant CMC problem areas that have been surfacing in regulatory filings for advanced therapy medicinal products (ATMPs) – potency testing and comparability. She also addressed the international activities underway to improve harmonization of approaches and alignment on regulatory decisions for ATMPs.
- [Week Ending July 25, 2025: Featuring EMA’s Rogers on CMC Problems and Harmonization Efforts for ATMPs](https://ipq.org/week-ending-july-25-2025-featuring-emas-rogers-on-cmc-problems-and-harmonization-efforts-for-atmps/) - At the June 2025 PDA Advanced Therapy Medicinal Product (ATMP) Conference held in Gothenburg, Sweden, EMA Pharmaceutical Quality Scientific Administrator Dolça Rogers discussed and shared case studies on: ● common CMC challenges for ATMPs and ● how the agency is engaging in international collaborations for more harmonized outcomes.
- [IPQ Monthly Update – June 2025 in Review](https://ipq.org/ipq-monthly-update-june-2025-in-review/) - The stories in IPQ's June Monthly Update explore the formulation and analytical challenges facing industry, regulators and pharmacopeias in their efforts to advance the development of the next generation of therapeutics and biosimilars. In focus in the lead story are insights provided at a “Biologics Summit” on the challenges and innovation requirements in developing the next generation of mRNA-LNP therapeutics, which was held in conjunction with the May 2025 IPEC-Americas Excipient World (EW) conference. The first two of the three stories drawn from June Weekly Supplements involve presentations at the EW conference on how USP is adapting and refining its tools, strategies and standards to better support the more complex excipients and formulations needed across the advanced therapy landscape. The third Weekly story shifts to USP’s effort to address key challenges in global biosimilar development and regulation discussed at the June 2025 DIA Global Annual Meeting.
- [Week Ending July 18, 2025: Featuring the Q&A at the June CASSS CGT Symposium Regulator Session](https://ipq.org/week-ending-july-18-2025-featuring-the-qa-at-the-june-casss-cgt-symposium-regulator-session/) - During the extended Q&A that concluded the regulatory session at the June 2025 CASSS CGTP Symposium, regulators from Italy, The Netherlands, Japan, Canada, and Spain shed further light on the issues and initiatives their respective agencies are engaged with at the national and international level to support cell and gene therapy development. Also participating in the Q&A was a former U.S. FDA CGT regulator.
- [Week Ending June 27, 2025: Featuring USP’s Koduri on Advancing Global Biosimilar Development](https://ipq.org/weeks-ending-june-27-2025-featuring-usps-koduri-on-advancing-global-biosimilar-development/) - At the 2025 DIA Global Annual Meeting, held in Washington, DC in mid-June, USP International Government and Regulatory Engagement Director Chaitanya Koduri provided an update on USP’s efforts to address key challenges in global biosimilar development and regulation. After introducing USP and biosimilars, he discussed current challenges to their adoption and the role of advanced analytical tools in reducing the need for clinical data. Koduri then shared insights from a 2024 global regulatory consultation on biosimilar standards, the findings of which are helping shape USP’s strategy for supporting biosimilar development, standardization and harmonization.
- [Weeks Ending July 4 & 11, 2025: Featuring International Panel on Regulator Initiatives to Support CGTs](https://ipq.org/weeks-ending-july-4-11-2025-featuring-international-panel-on-regulator-initiatives-to-support-cgts/) - At the 2025 CASSS Cell and Gene Therapy Products (CGTP) Symposium, held in Rockville, Maryland in early June, a panel of international regulatory leaders shed light on the strategies their respective agencies are pursuing to support the rapidly evolving CGT field and how these connect with broader regional and global convergence efforts.
- [Excipient/Formulation Challenges for Next-Generation mRNA-LNP Therapeutics Draw IPEC/CRS Workshop Spotlight](https://ipq.org/excipient-formulation-challenges-for-next-generation-mrna-lnp-therapeutics-draw-ipec-crs-workshop-spotlight/) - The excipient and formulation challenges associated with lipid nanoparticle (LNP) delivery systems are emerging as a pivotal issue in advancing the mRNA field beyond vaccines for infectious diseases into broader therapeutic applications including protein replacement therapy and gene editing. The functional performance of LNP lipids is deeply interdependent with the nanoparticle’s composition and structure – differentiating them from traditional excipients and making them more like “functional excipients” in their impact on product performance.
- [Weeks Ending June 13 & 20, 2025: Featuring USP Experts on Supporting Complex Excipients and Formulations](https://ipq.org/week-ending-june-13-20-2025-featuring-usp-experts-on-supporting-complex-excipients-and-formulations/) - At the 2025 IPEC-Americas Excipient World Conference, held in Maryland in mid-May, USP Senior Director for Global Science and Standards in Foods and Excipients Catherine Sheehan reviewed USP’s emerging/evolving approaches for addressing: ● excipient quality challenges ● phospholipid standards and solutions for complex injectables, and ● novel excipients and CGTs. In talks the next day, Sampada Kharade spotlighted USP’s engagement with the challenges of LG polymers, and Katie McGowan focused on USP’s Donations Program and how it supports excipients not yet covered by compendial standards.
- [IPQ Monthly Update – May 2025 in Review](https://ipq.org/ipq-monthly-update-may-2025-in-review/) - Included in the May Monthly are the five “regulator spotlight” stories that were featured in IPQ Weekly Supplements during the month. Drawing from presentations at recent conferences, the stories encompass: ● a review of ICMRA collaborative pilot learnings and next steps by EMA’s Kotzagiorgis and Cuddy ● the benefits for post-approval changes flowing from the Egyptian Drug Authority’s international reliance journey ● a discussion by MHRA’s Jackson of PIC/S training and harmonization goals ● MHRA’s data-driven compliance strategy for addressing a changing landscape, and ● insights on CMC regulatory considerations for individualized cancer immunotherapies from MHRA’s Wan.
- [Week Ending June 6, 2025: Featuring USP’s Wang on Pharmacopeial Strategies for Addressing Emerging Excipient/Formulation Challenges](https://ipq.org/week-ending-june-6-2025-featuring-usps-wang-on-pharmacopeial-strategies-for-addressing-emerging-excipient-formulation-challenges/) - Reflective of the important role that pharmacopeial standards and guidance play in quality regulatory processes around the world, IPQ will now be including key presentations by pharmacopeial leaders at recent conferences to the coverage of regulator insights in our Weekly Supplements. At the 2025 IPEC-Americas Excipient World Conference, held in Maryland in mid-May, USP Senior Manager for Excipients Hong Wang reviewed USP’s evolving excipient strategies and recent standards initiatives. Her presentation covered: ● an introduction to excipients and the USP excipient strategy ● the excipient nomenclature guideline ● evolving/iterative approaches, and ● USP’s “Flexible Solution: Materials Program.”
- [Week Ending May 30, 2025: Featuring MHRA’s Wan on CMC for Individualized mRNA Cancer Immunotherapies](https://ipq.org/week-ending-may-30-2025-featuring-mhras-wan-on-cmc-for-individualized-mrna-cancer-immunotherapies/) - At the “regulatory considerations” session of the CASSS/AMM mRNA symposium, held in Gaithersburg, MD in late May 2025, Medicines and Healthcare Products Regulatory Agency (MHRA) Senior Pharmaceutical Assessor Ka-Wei Wan provided an overview of MHRA’s engagement with individualized mRNA cancer immunotherapies, with a focus on the CMC issues involved. After outlining developments in the mRNA field, she discussed the draft guidance that MHRA released on the regulatory considerations for individualized mRNA cancer immunotherapies. She then highlighted the comments received on the draft and some of the next steps MHRA will be taking to facilitate product development and the regulatory interface.
- [Week Ending May 23, 2025: Featuring MHRA’s Brown on the Agency’s Evolving Compliance Strategy](https://ipq.org/week-ending-may-23-2025-featuring-mhras-brown-on-the-agencys-evolving-compliance-strategy/) - At the 2025 Making and Distributing Pharmaceuticals conference held in Coventry, UK, in late April, MHRA Expert GDP Inspector Peter Brown reviewed: • MHRA organizational developments • recent regulatory reforms • the future outlook for the agency • compliance trends • case studies on falsified medicines and poor data governance, and • industry trends and challenges.
- [Week Ending May 16, 2025: Featuring an Update on PIC/S by MHRA’s Ian Jackson](https://ipq.org/week-ending-may-16-2025-featuring-an-update-on-pic-s-by-mhras-ian-jackson/) - At the ISPE Europe 2025 Annual Meeting held in London in mid-May, MHRA Expert GMP Inspector Ian Jackson gave a presentation on behalf of the Pharmaceutical Inspection Cooperation Scheme (PIC/S), outlining its work on “quality, standards, capability, harmonization, confidence, and collaboration.” He discussed: ● the background to PIC/S ● PIC/S’ role in GMP harmonization, and ● PIC/S’ strategic plan and future directions.
- [IPQ Monthly Update – April 2025 in Review](https://ipq.org/ipq-monthly-update-april-2025-in-review/) - The lead story in the April Monthly Update focuses on the industry/regulator discussions that took place at an October 2024 DIA/FDA oligonucleotide conference of how the knowledge gained in addressing the CMC challenges of mRNA COVID-19 vaccines can be leveraged in the therapeutics arena. Receiving attention were the tailored control strategies needed to address the challenges posed by the expanding diversity of mRNA therapeutic modalities. Also included in this issue are the four stories that were featured in IPQ Weekly Supplements during the month, which provide insights from leading regulators on: ● how the revised EU variation classification guideline will address the impact and risk of combination product changes ● Health Canada’s GMP inspection findings and shift toward a more risk-based collaborative framework ● African medicines regulatory harmonization and the milestone reached with the first continental listing of collaboratively reviewed products, and ● UK MHRA’s preparations to implement a new regulatory framework for decentralized manufacturing.
- [Week Ending May 9, 2025: Featuring Egypt and EMA Regulators on Reliance Progress and Benefits](https://ipq.org/week-ending-may-9-2025-featuring-egypt-and-ema-regulators-on-reliance-progress-and-benefits/) - In a March 2025 webinar jointly sponsored by EFPIA, EUCOPE, EuropaBio, IFPMA, and Vaccines Europe, Egyptian Drug Authority’s Asmaa Fouad shared EDA’s “story of trust and transparency” in establishing reliance practices and the benefits that have been realized for post-approval changes. EMA’s Emer Cooke and Martin Harvey gave opening and closing remarks, respectively, in which they stressed the global importance of reliance tools and the key role EMA plays in sharing assessment outputs.
- [Week Ending May 2, 2025: Featuring EMA's Kotzagiorgis and Cuddy on ICMRA Pilots and Their Extension](https://ipq.org/week-ending-may-2-2025-featuring-emas-kotzagiorgis-and-cuddy-on-icmra-pilots-and-their-extension/) - The International Coalition of Medicines Regulatory Authorities (ICMRA) has extended its two regulatory collaborative pilot programs – the Collaborative Assessment Pilot (CAP) and the Collaborative Hybrid Inspection Pilot (CHIP) – and will continue to accept applications until the end of 2025. At the DIA Europe Conference session on “global partnerships to accelerate availability of quality medicines” held in Basel in March 2025, EMA leaders discussed the latest ICRMA Pilot updates, key learnings, and future directions. EMA Quality Specialist Evangelos Kotzagiorgis focused on the CAP initiative and EMA Lead Scientific Officer Brendan Cuddy reviewed CHIP.
- [Week Ending April 25, 2025: Featuring MHRA's Rees and Gray on New UK Regulatory Framework for Decentralized Manufacturing](https://ipq.org/week-ending-april-25-2025-featuring-mhras-rees-and-gray-on-new-uk-regulatory-framework-for-decentralized-manufacturing/) - In a late January 2025 webinar on “Modular Manufacturing and Point-of-Care Regulations,” Medicines and Healthcare Products Regulatory Agency (MHRA) leaders discussed the new regulatory framework to support decentralized manufacturing (DM) that comes into force in the UK in July 2025. MHRA Inspectorate Strategy and Innovation Unit Manager Ian Rees covered: • MHRA responsibilities, mission and vision • an overview of the new DM framework • manufacturing technology models • the new legislation, and • international and institutional perspectives. Expert Pharmaceutical Assessor Elspeth Gray followed with a discussion of: • the qualifying tests that define eligibility for decentralized manufacturing, and • the DM master file. Rees returned to discuss future steps, including guidances, workshops, and international collaborations.
- [IPQ Monthly Update – March 2025 in Review](https://ipq.org/ipq-monthly-update-march-2025-in-review/) - Included in the March Monthly are the four “regulator spotlight” stories that were featured in IPQ Weekly Supplements during the month. They encompass: ● a CASSS CMC Strategy Forum at which Health Canada’s Siggers reviewed data model challenges and regulatory experience/needs ● a UNICEF/UNEFPA/WHO meeting where light was shed on the CMC/GMP support WHO is providing for local medicine production ● a presentation by EMA’s Hernan on the Quality Innovation Group’s role, focus, and activities in advancing CMC technology, and ● the 2025 CASSS WCBP symposium at which a panel of global regulatory leaders explored the progress in convergence, reliance, collaboration, access, and biomanufacturing innovation, and how that progress can be furthered in the future.
- [Week Ending April 18, 2025: Featuring AMRH Leaders on the First Continental Listing of Medicinal Products Assessed by African Regulators](https://ipq.org/week-ending-april-18-2025-featuring-amrh-leaders-on-the-first-continental-listing-of-medicinal-products-assessed-by-african-regulators/) - At a late March meeting of the African Medicines Regulatory Harmonization (AMRH) Steering and Technical Committees, a press briefing was held to announce the first continental listing of medicinal products that have undergone assessment and inspection by African regulators and highlight its significance as a milestone in the AMRH effort to enable more efficient approval timelines and faster access to African patients.
- [Leveraging mRNA Vaccine CMC Learnings in the Evolving Therapeutics Arena Draws Spotlight at DIA/FDA Conference](https://ipq.org/leveraging-mrna-vaccine-cmc-learnings-in-the-evolving-therapeutics-arena-draws-spotlight-at-dia-fda-conference/) - The DIA/FDA conference on oligonucleotide therapeutics, held in Washington DC in October 2024, provided an opportunity for industry and agency experts to exchange insights on how the knowledge gained in addressing the CMC challenges of mRNA COVID-19 vaccines can be leveraged in the therapeutics arena. At a session of the conference focused on “CMC considerations in the development of mRNA-based therapeutics,” participants highlighted the common structural characteristics and processes between mRNA vaccines and therapeutics, which offer the potential to extrapolate CMC learnings involving purity/impurity profiles and other CQAs, lipid nanoparticle (LNP) stability, phase appropriate specifications, and shelf-life.
- [IPQ Monthly Update – February 2025 in Review](https://ipq.org/ipq-monthly-update-february-2025-in-review/) - Included in the February Monthly are the four “regulator spotlight” stories that were featured in IPQ Weekly Supplements during the month. These provide current insights from leading regulators on: ● the progress of the ICH Q6 revision ● EMA Quality Innovation Group initiatives, including its engagement with process models ● sterile process data handling, and ● regulatory strengthening in Africa.
- [Week Ending April 11, 2025: Featuring Health Canada's Joseph on HC Inspection Findings and Advancements](https://ipq.org/week-ending-april-11-2025-featuring-health-canadas-joseph-on-hc-inspection-findings-and-advancements/) - At the 2025 University of Georgia/FDA International GMP Conference, held on the UGA campus in early March, Health Canada GMP Inspection Regional Manager Magda Joseph reviewed the compliance and enforcement activities of the agency’s Regulatory Operations and Enforcement Branch (ROEB). She provided: ● an introduction to ROEB’s mandate, structure and activities ● an overview of GMP trends from an HC perspective, with particular emphasis on Annex 1 and foreign facility compliance, and ● an update on key initiatives, including mutual recognition agreements (MRAs), international collaborations, and artificial intelligence.
- [Week Ending April 4, 2025: Featuring EMA's Rojo on Combination Product Lifecycle Expectations](https://ipq.org/week-ending-april-4-2025-featuring-emas-rojo-on-combination-product-lifecycle-expectations/) - At the 2025 DIA/RAPS Summit on Combination Products in the EU, held in Brussels at the end of January, EMA Procedures Office Head Virginia Rojo gave an update on the agency’s ongoing efforts to support companies in dealing with lifecycle management of combination products (CPs). She discussed the relationship between the current CP guidance and the draft variation classification guidance, and the increased focus on assessing the risk and impact of changes to the medicinal product.
- [Week Ending March 28, 2025: Featuring Global Regulatory Panel on Convergence, Reliance, Collaboration, Access, and Innovation](https://ipq.org/week-ending-march-28-2025-featuring-global-regulatory-panel-on-convergence-reliance-collaboration-access-and-innovation/) - A panel session at the 2025 CASSS WCBP Conference brought together international regulatory leaders to discuss “navigating the regulatory landscape: global convergence and innovation in biopharmaceutical manufacturing.” Participating in the panel discussion were Japan PMDA’s Yasuhiro Kishioka and Akihiro Ishiguro, EMA’s Anabela Marçal, Swissmedic’s Claudia Müller, Health Canada’s Sophie Sommerer, and WHO’s Rogério Gaspar. The panelists began by explaining the roles their departments play and the structure, mission, key priorities, and recent regulatory and legislative initiatives of their respective agencies and WHO. The Q&A that followed allowed the panelists to further explore: ● inter-agency collaborations between EMA, FDA, and other agencies ● the Access Consortium and assessment of CGTs ● the role of PMDA’s new office in Washington DC ● initiatives to support innovation in manufacturing and technology ● interactions between reviewers and inspectors ● information sharing through Accumulus and other IT platforms ● learnings from and evolution of the ICMRA assessment pilots, and ● alignment on platform technology designations.
- [Week Ending March 21, 2025: Featuring EMA's Hernan on the Quality Innovation Group's role and impact](https://ipq.org/week-ending-march-21-2025-featuring-emas-hernan-on-the-quality-innovation-groups-role-and-impact/) - At the 2025 IFPAC meeting, held in Bethesda, Maryland, in early March, EMA Senior Quality Specialist Dolores Hernan reviewed the role and activities of EMA’s Quality Innovation Group (QIG) in helping foster the flexibility, clarity, and global convergence in regulatory expectations and processes needed to support technological progress in the CMC arena.
- [Week Ending March 14, 2025: Featuring Kim Notenboom on WHO’s CMC/GMP Assistance Program](https://ipq.org/week-ending-march-14-2025-featuring-kim-notenboom-on-whos-cmc-gmp-assistance-program/) - At the 2024 UNICEF/UNFPA/WHO Manufacturers and Suppliers Meeting held in UN City Copenhagen in early December, members of WHO’s Local Product & Assistance (LPA) Unit provided insights into the unit’s technical assistance program. The TA program supports manufacturers in achieving compliance with international regulatory norms and standards in order to obtain WHO prequalification status for a medical product. The feature story in this Weekly Supplement focuses on the presentation at the meeting by Kim Notenboom, who was then completing a two-year assignment to the LPA Unit. She returned in January to the Dutch Medicines Evaluation Board, where she serves as a senior quality assessor and drug shortages expert. Included in her talk were case studies illustrating how WHO assists in meeting CMC and GMP expectations.
- [IPQ Monthly Update – January 2025 in Review](https://ipq.org/ipq-monthly-update-january-2025-in-review/) - The lead story in IPQ’s January 2025 Monthly Update focuses on the EFPIA “satellite session” at the October 2024 CASSS Europe CMC Strategy Forum, at which experts from EFPIA’s biomanufacturing group discussed the key issues that are getting the association’s attention and the contributions that the group is making to addressing them – both in Europe and internationally. Among the key priorities is expanding regulatory dialogue on the use of MS-based MAM as a QC tool. Also included in the January Monthly are the stories that were featured in IPQ Weekly Supplements during the month. These provide “current insights from leading regulators” on: ● 3-D printing and other distributed manufacturing issues ● regulatory strengthening to increase quality medicine access ● global regulatory partnerships and harmonization ● FDA engagement in India, and ● EMA’s evolving regulatory approach to prior knowledge and platforms.
- [Week Ending January 17, 2025: Featuring FDA’s Trzeciak on Need for Global Partnerships and Harmonization](https://ipq.org/week-ending-january-17-2025-featuring-fdas-trzeciak-on-need-for-global-partnerships-and-harmonization/) - At the 19th International Conference of Drug Regulatory Authorities (ICDRA), held in New Delhi, India in October 2024, FDA Deputy Commissioner for Policy, Legislation, and International Affairs Kimberlee Trzeciak discussed the strong engagement of FDA with WHO and its initiatives and how risk mitigation and global regulatory partnerships and harmonization are key elements in maintaining a strong regulatory foundation for medicinal product quality and access.
- [Week Ending March 7, 2025: Featuring Health Canada's Siggers on CMC Data Models](https://ipq.org/week-ending-march-7-2025-featuring-health-canadas-siggers-on-cmc-data-models/) - At the CMC Strategy Forum North America, held in Washington DC, in late January 2025 in conjunction with the CASSS WCBP Conference, Health Canada Biologics and Radiopharmaceutical Drugs Directorate (BRDD) Senior Evaluator Jayda Siggers reviewed the expectations and challenges of using predictive data models to support marketing authorizations in the CMC arena. Her presentation covered: ● the types of data models submitted to Health Canada to date ● a case study involving the use of process capability and stability models for a monoclonal antibody submission ● reflections on lessons learned on model use ● a review of the regulatory expectations for data models, including filing requirements, and ● key takeaways.
- [Week Ending February 28, 2025: Featuring MHRA’s Odeh on the Progress of the ICH Q6 Revision](https://ipq.org/week-ending-february-28-2025-featuring-mhras-odeh-on-the-progress-of-the-ich-q6-revision/) - At the JPAG Regulatory Hot Topics IX Symposium, held in London, UK, in December 2024, MHRA Head of New Active Substances - Innovative Medicines Bassel Odeh explored the progress of the ICH Expert Working Group (EWG), of which he is a member, in revising and modernizing the Q6A and Q6B guidelines on the specifications for drug substances and drug products and the principles guiding the effort.
- [Week Ending February 21, 2025: Featuring HPRA’s Lee on EMA QIG and Process Models](https://ipq.org/week-ending-february-21-2025-featuring-hpras-lee-on-ema-qig-and-process-models/) - At the 2024 ISPE Pharma 4.0 & Annex 1 Conference held in Rome, Italy in December 2024, Ireland Health Products Regulatory Authority (HPRA) Executive Pharmaceutical Assessor Nick Lee provided an update on the EMA Quality Innovation Group (QIG) initiatives concerning pharmaceutical process models. He reviewed: ● the background on the QIG work, including the draft guidance on “Preliminary QIG Considerations on Pharmaceutical Process Models” ● process model risk analysis, and ● documenting data in the dossier.
- [Week Ending February 14, 2025: Featuring AGES’ Bauer and Meissner on Sterile Process Data Handling](https://ipq.org/week-ending-february-14-2025-featuring-ages-bauer-and-meissner-on-sterile-process-data-handling/) - Manufacturers need to leverage strategic data management to maintain process stability and foster optimization of sterile manufacturing, Austria Agency for Health and Food Safety’s Ronald Bauer and Christina Meissner stressed in their joint presentation at the 2024 ISPE Pharma 4.0 & Annex 1 conference, held in Rome, Italy, in December 2024. Bauer began by reviewing the general regulatory expectations for data governance, including: ● the development of a validation strategy ● risk analysis ● ensuring data integrity, and ● using data for process optimization. Meissner then addressed applying these principles to sterile manufacturing, focusing on data sources in sterile manufacturing and the contamination control strategy of Annex 1. Bauer then returned to the podium to impart some key take home messages.
- [Week Ending February 7, 2025: Featuring SAHPRA, WHO, and EMA on Regulatory Strengthening in Africa](https://ipq.org/week-ending-february-7-2025-featuring-who-ema-and-saphra-on-regulatory-strengthening-in-africa/) - At the African Medicines Regulatory Harmonization (AMRH) Week, held at the end of October 2024 in Maputo, Mozambique, regional and global leaders in healthcare policy and medical product regulation came together to discuss regulatory collaboration and system strengthening in Africa. Setting the stage during the opening session were SAHPRA’s Semete-Makokotlela, WHO’s Gaspar, and EMA’s Cooke, who drew from their wealth of regulatory experience and depth of global engagement in explaining the importance of the progress that has been made, what it took to achieve it, and the ongoing collaborative effort that is needed to propel the progress forward.
- [EFPIA Manufacturing and Quality Group Focus Areas for 2025 Include Engaging with Regulators on the Multi-Attribute Method as a QC Tool](https://ipq.org/efpia-manufacturing-and-quality-group-focus-areas-for-2025-include-engaging-with-regulators-on-the-multi-attribute-method-as-a-qc-tool/) - Among the focus areas of the European Federation of Pharmaceutical Industries and Associations (EFPIA) Manufacturing and Quality Expert Group (MQEG) for 2025 is engaging with regulators on the issues around using the mass spec (MS)-based multi-attribute method (MAM) as a QC tool. MQEG leaders had the opportunity to explore the group’s priorities for the coming year at the traditional EFPIA satellite session accompanying the CASSS CMC Strategy Forum Europe, held in mid-October 2024 in Rotterdam, The Netherlands.
- [IPQ Monthly Update – November/December 2024 in Review](https://ipq.org/ipq-monthly-update-november-december-2024-in-review/) - IPQ’s immersion in the global regulatory dialogue on evolving the quality paradigm in pharmaceutical operations continues in the lead story in this issue, which reviews the discussions that took place at the “Quality Business Leadership Summit” held at the Technological University (TU) Dublin. The meeting explored how to speed up pharma’s progress from a compliance to a quality investment value modus operandi that better drives innovation, financial performance, and supply chain resilience. Also included are the stories that were featured in IPQ Weekly Supplements during the two months. These provide “current insights from leading regulators” on: ● mass spec use for biotherapeutics control ● the ICH Q6 revision initiative ● the ATMP contributions of EMA’s CAT ● the need for global regulatory collaboration for addressing drug quality and shortages ● the regulatory landscape for generics and biosimilars ● the CMC challenges of mRNA therapies, and ● FDA’s combination product intercenter consult process.
- [Week Ending January 31, 2025: Featuring EMA’s Shivji on Prior Knowledge and Platforms](https://ipq.org/week-ending-january-31-2025-featuring-emas-shivji-on-prior-knowledge-and-platforms/) - At the October 2024 CASSS CMC Europe Strategy Forum, EMA Pharmaceutical Quality Senior Specialist/Vaccine Technical Lead Ragini Shivji provided an update on the issues that are on the table as the EU works with industry to advance Europe’s regulatory approach to the deployment of prior knowledge and platform technologies in the CMC arena.
- [Week Ending January 24, 2025: Featuring FDA India Office’s Deepening Engagement with Indian Regulators and Industry](https://ipq.org/week-ending-january-24-2025-featuring-fda-india-offices-deepening-engagement-with-indian-regulators-and-industry/) - At the Indian Pharmaceutical Alliance (IPA) 2024 Advanced GMP Workshop held in Mumbai, India in late October, FDA India Office Director Greg Smith explained how his office’s engagement with India’s central and state regulators and with industry has deepened since the office was established 15 years ago and now includes a broad range of collaborative activities and shared learnings. He explained the importance of India to the U.S. drug supply chain and reviewed the results of the FDA inspection program there, in which Indian regulators are participating.
- [Industry Paradigm Shift from Compliance to Quality Investment Value Urged at Dublin Summit](https://ipq.org/industry-paradigm-shift-from-compliance-to-quality-investment-value-urged-at-dublin-summit/) - A “Quality Business Leadership Summit” (QBL), held in Dublin, Ireland in May 2024, brought industry, regulator and academic experts together to explore how to speed up pharma’s progress from a compliance to a quality investment value modus operandi that better drives innovation, financial performance, and supply chain resilience. At the summit, hosted by the Pharmaceutical Regulatory Science Team (PRST) at the Technological University (TU) Dublin, prominent leaders in the quality regulatory dialogue from the US and Europe took stock of where the pharmaceutical industry is on this journey, where the constraints and hurdles now lie, and what needs to be done to make this “fundamental shift” a reality.
- [Week Ending January 10, 2025: Featuring Global Leaders on Advancing Regulatory Collaboration](https://ipq.org/week-ending-january-10-2025-featuring-global-leaders-on-advancing-regulatory-collaboration/) - The 19th International Conference of Drug Regulatory Authorities (ICDRA), held in New Delhi, India in October, 2024, brought leaders from all over the world together to review and further advance the global collaborative efforts to create more effective regulatory oversight and better assure medical product quality and access. The week-long conference was split into a “pre-ICDRA” component, in which regulators and other key stakeholders participated, and a regulator-only second part. This story concentrates on the insights provided at the two opening sessions by leaders from the sponsoring organizations, WHO and the government of India, regarding the regulatory progress that has been made in the wake of the pandemic and how that progress can be advanced going forward. The next Weekly Supplement will focus on a keynote presentation by the senior FDA delegate at the conference and her post-conference reflections.
- [Week Ending January 3, 2025: Featuring FDA’s Zidan on Distributed/POC Manufacturing and 3-D Printing](https://ipq.org/week-ending-january-3-2025-featuring-fdas-zidan-on-distributed-poc-manufacturing-and-3-d-printing/) - At the AAPS Pharm Sci 360 conference, held in Salt Lake City, Utah, in October 2024, CDER Office of Pharmaceutical Quality (OPQ) Senior Research Pharmacologist Ahmed Zidan reviewed distributed and point-of-care manufacturing and the regulatory considerations for them. He then focused in on 3-D printing ― providing a case study on its use in manufacturing personalized intravaginal rings and related FDA research.
- [Week Ending December 27, 2024: Featuring FDA Leaders on Combination Product Regulatory Developments](https://ipq.org/week-ending-december-27-2024-featuring-fda-leaders-on-combination-products-regulatory-developments/) - At the October 2024 AFDO/RAPS Combination Products Summit, held in Providence, Rhode Island, FDA Office of Combination Products Director James Bertram began the opening session by commenting on the AFDO/RAPS/FDA collaboration, OCP’s personnel and organizational changes, and the office’s role and responsibilities. Office of the Chief Medical Officer Information Management Associate Director Danita Dixon then explained the evolution and importance of the agency’s intercenter consult request (ICCR) program. Bertram returned to the podium to discuss OCP data from FY 2023 and outline recent activities and current strategic priorities.
- [Week Ending December 20, 2024: Featuring CBER's Levenson on CMC Challenges for mRNA Therapies](https://ipq.org/week-ending-december-20-2024-featuring-cbers-levenson-on-cmc-challenges-for-mrna-therapies/) - At the DIA/FDA Oligonucleotide-Based Therapeutics Conference, held in Washington DC in October 2024, CBER’s Office of Therapeutic Products (OTP) Biological Reviewer Eric Levenson discussed considerations for determining the critical quality attributes and specifications for mRNA therapies. He reviewed: ● the regulatory status of mRNA vaccines and therapeutics ● CMC considerations, including in-process and release testing and stability studies across the diversity of mRNA product types, and ● new draft potency guidance for CGTs.
- [Week Ending December 13, 2024: Featuring FDA’s Corrigan-Curay on GRx/Biosims Landscape](https://ipq.org/week-ending-december-13-2024-featuring-fdas-corrigan-curay-on-grx-biosims-landscape/) - At the AAM Generics and Biosimilars Conference, held in Maryland in October 2024, CDER Principal Deputy Director Jacqueline Corrigan-Curay reviewed the regulatory landscape for generics and biosimilars, describing the current state of play and outlining future CDER priorities and goals. She addressed: ● FY 2024 highlights for CDER’s generics drug program, including GDUFA and other commitments ● FY24 highlights for the biosimilars program, including BsUFA innovations, and ● quality management, compliance and supply chain concerns.
- [Week Ending December 6, 2024: Featuring FDA's Mullin on Global Collaboration in Addressing Shortages](https://ipq.org/weeks-ending-december-6-2024-featuring-fdas-mullin-on-global-collaboration-in-addressing-shortages/) - At the October 2024 ISPE Annual Meeting in Orlando, Florida, FDA CDER Strategic Initiatives Associate Center Director Theresa Mullin explored how regulator and company agility in managing pharmaceutical quality is pivotal in addressing the problems of drug shortages and availability and how international regulatory collaboration and harmonization is key in supporting that agility. She addressed: ● the need for a reliable supply of medicines ● causes of drug shortages ● post-approval changes (PACs) as part of effective pharmaceutical quality management ● the vision of the International Coalition of Medicines Regulatory Authorities (ICMRA) for global pharmaceutical quality knowledge management (PQKM) capability ● the ICMRA collaborative assessment and inspection pilot studies, and ● further efforts in the PQKM project.
- [Weeks Ending November 22 & 29, 2024: Featuring Leaders of EMA’s CAT on Its ATMP Contributions](https://ipq.org/weeks-ending-november-22-29-2024-featuring-leaders-of-emas-cat-on-its-role/) - At an October EMA-hosted scientific symposium on advanced therapy medicinal products (ATMPs), two leaders of the 15-year-old Committee for Advanced Therapies, AGES’ Ilona Reischl and EMA’s Patrick Celis, outlined CAT’s contributions, lessons learned, current activities, and future challenges in both the European and international arenas.
- [Week Ending November 15, 2024: Featuring an Update on ICH Q6(R1) by EWG Member Mats Welin](https://ipq.org/weeks-ending-november-15-2024-featuring-an-update-on-ich-q6r1-by-ewg-member-mats-welin/) - At the September 2024 PDA Biomanufacturing Conference held in Gothenburg, Sweden, MPA Senior Expert Mats Welin, a member of the ICH Q6(R1) Expert Working Group, explored: ● the current status of the ICH specification guidelines Q6A & Q6B ● the aim to modernize and harmonize the guidelines ● the Q6(R1) initiative deliverables ● issues for discussion, and ● considerations for biologicals.
- [IPQ Monthly Update – September/October 2024 in Review](https://ipq.org/ipq-monthly-update-september-october-2024-in-review/) - The September/October 2024 issue continues IPQ’s coverage of the industry/regulator dialogue at the Duke-Margolis meeting in August on how the communication pathways could be broadened to facilitate a more efficient CMC review process and improve outcomes for biological license applications (BLAs) submitted to FDA’s Center for Drug Evaluation and Research. Also included are the stories that were featured in IPQ Weekly Supplements during the two months. These provide “current insights from leading regulators” on: ● the ICMRA collaborative PAC assessment and inspection pilots ● ADC characterization and control challenges and guidance gaps ● India’s quality oversight enhancements ● Australia’s inspection reliance framework, and ● FDA’s platform and advanced manufacturing guidance initiatives.
- [Weeks Ending October 18 & 25, 2024: Featuring FDA’s Levis on Platform and Advanced Manufacturing Technology Guidances](https://ipq.org/weeks-ending-october-18-25-2024-featuring-fdas-levis-on-platform-and-advanced-manufacturing-technology-guidances/) - At the September 2024 PDA Biomanufacturing Conference held in Gothenburg, Sweden, FDA CBER Division of Viral Products Deputy Director Robin Levis discussed the impact of the pandemic on regulatory collaboration/harmonization and provided an update on the FDA guidance initiatives on platform and advanced manufacturing technologies that have followed.
- [Weeks Ending November 1 & 8, 2024: Featuring FDA/USP/NIST Panel on Mass Spec Regulatory Trends](https://ipq.org/weeks-ending-november-1-8-2024-featuring-fda-usp-nist-panel-on-mass-spec-regulatory-trends/) - At the September 2024 CASSS Mass Spectrometry Symposium, a panel of experts from FDA, USP and NIST addressed MS “trends in regulatory research, review, and standards.” Sample preparation, inter-lab variability, and the use of MS in host cell protein profiling and of the MS-based multi-attribute methodology in quality control were among the topics in the spotlight
- [Weeks Ending October 4 & 11, 2024: Featuring TGA’S Burnett on Australia’s Inspection Reliance Framework](https://ipq.org/weeks-ending-october-4-11-2024-featuring-tgas-burnett-highlights-australias-inspection-reliance-framework/) - At the late August 2024 ISPE Singapore Conference, Australia’s Therapeutic Goods Administration (TGA) Manufacturing Quality Branch Assistant Secretary Jennifer Burnett discussed: ● regulatory requirements for manufacturers within Australia and overseas ● TGA’s GMP inspection reliance framework, and ● global alignment and complex supply chains.
- [FDA and Industry Thought Leaders Explore How CMC Communication Pathways Can be Broadened to Improve BLA Review Outcomes at Duke-Margolis Workshop](https://ipq.org/fda-and-industry-thought-leaders-explore-how-cmc-communication-pathways-can-be-broadened-to-improve-bla-review-outcomes-at-duke-margolis-workshop/) - The industry/FDA dialogue at an August meeting in Washington, DC, sponsored by the Duke-Margolis Institute for Health Policy resulted in some substantive ideas on how the communication pathways could be broadened to facilitate a more efficient CMC review process and improve outcomes for biological license applications (BLAs) submitted to the Center for Drug Evaluation and Research (CDER). Explored were the communication pathways between sponsors and FDA and the increased communication challenges that result from CMO participation in the manufacturing process.
- [Week Ending September 27, 2024: Featuring CDSCO's Raghuvanshi on Quality Oversight in India](https://ipq.org/week-ending-september-27-2024-featuring-cdscos-raghuvanshi-on-quality-oversight-in-india/) - At the Indian Pharmaceutical Alliance (IPA) 9th Global Pharmaceutical Quality Summit, held in Mumbai in late June 2024, India Central Drugs Standard Control Organisation (CDSCO) Drugs Controller General Rajeev Raghuvanshi spoke about the efforts to strengthen quality oversight in India. He addressed: ● regulatory non-compliance and quality issues ● capacity building projects in the CDSCO pipeline ● approval timelines in different divisions, and ● potential areas of weakness.
- [Week Ending September 20, 2024: Featuring FDA and Health Canada Reviewers on CMC Issues for ADCs](https://ipq.org/week-ending-september-20-2024-featuring-fda-and-health-canada-reviewers-on-cmc-issues-for-adcs/) - Featured in this Weekly Supplement are insights from FDA and Health Canada reviewers on the challenges confronting sponsors in moving from the individual components of an antibody-drug conjugate (ADC) to the combination product and what additional guidance is needed to help sponsors in addressing them. At a session on “leveraging learnings from global approvals” at the July 2024 CASSS CMC Strategy Forum North America, CDER OPQ reviewer Kanny Wan discussed the regulation of ADCs from the small molecule perspective, while Health Canada Biotherapeutics evaluator Félix Jules explored the biologics considerations.
- [Week Ending September 13, 2024: Featuring PEI’s Merz on CMC Issues for ADCs](https://ipq.org/week-ending-september-13-2024-featuring-peis-merz-on-cmc-issues-for-adcs/) - At the June 2024 CASSS Strategy Forum, Paul Ehrlich Institute (PEI) Non-Clinical/Quality Assessor for Antibody Therapeutics Christian Merz provided “a European regulator’s perspective” on the expectations for characterization and control of antibody drug conjugates (ADCs). He addressed: ● the timeline of ADC development from 1950 to present ● the versatility of ADC design, including antibody format, cytotoxic payload and linker type ● the assignment of starting materials ● European regulator advice on sponsor questions sponsor questions, and ● applying existing guidance and the gaps that need filling.
- [IPQ Monthly Update – July/August 2024 in Review](https://ipq.org/ipq-monthly-update-july-august-2024-in-review/) - The lead story in IPQ’s July/August Monthly Update focuses on the 2024 USP workshop on therapeutic peptides and oligonucleotides, which continued its tradition of bringing leading regulator, industry, pharmacopeia and academic experts together to assess the evolving CMC regulatory and standards-setting landscape for these two rapidly expanding product classes. Also provided are “current insights from leading regulators” on: ● EMA’s collaborative efforts on implementing the revised Annex 1 ● DEG/EG risks and testing ● the challenges in developing and validating rapid microbial methods ● the mandate for international collaboration and reliance ● EMA/developer interplay for gene therapies ● FDA’s emphasis on a risk-based control strategy for CGT potency assurance ● comparability experience with cell-based therapies and a path towards harmonization ● CMC issues in CDER Complete Response Letters (CRLs) for BLAs, and ● EDQM’s 2024-27 strategy.
- [Week Ending September 6, 2024: Featuring EMA and FDA Leaders on ICMRA’s PAC Pilots](https://ipq.org/week-ending-september-6-2024-featuring-ema-and-fda-leaders-on-imcras-pac-pilots/) - At the CASSS CMC Strategy Forum Latin America held virtually in August 2024, EMA Quality Specialist Evangelos Kotzagiorgis and FDA Office of Pharmaceutical Manufacturing Assessment Director Stelios Tsinontides reviewed the process, outcomes, survey results, lessons learned and future directions regarding the ICMRA pilots on collaborative post-approval change (PAC) assessments and inspections, respectively.
- [Week Ending August 30, 2024: Featuring EDQM Leaders on the Directorate’s Strategy for 2024-27](https://ipq.org/week-ending-august-30-2024-featuring-edqm-leaders-on-the-directorates-strategy-for-2024-27/) - At the European Directorate for the Quality of Medicines and HealthCare (EDQM) conference held in early June in Strasbourg, France in conjunction with EDQM’s 60th Anniversary, EDQM leaders laid out the directorate’s strategy for 2024-27. The strategy builds on the success of current collaborative and reliance activities, including the Certificate of Suitability (CEP) procedure and the Official Medicine Control Laboratories (OMCL) network. At the two-day conference: ● Director Petra Doerr outlined the future plans for EDQM’s contribution to public health ● former Director Susanne Keitel and Certification Department Head Helene Bruguera were interviewed about the CEP procedure, and ● OMCL Network & HealthCare Department Biological Standardization Head Laurent Mallet and General European OMCL Network (GEON) Advisory Group member Katerina Brezovska shared their insights on the proactive measures being taken to foster trust and transparency across the network.
- [Week Ending August 23, 2024: Featuring an FDA Panel on CMC Deficiencies in CDER BLAs](https://ipq.org/week-ending-august-23-2024-featuring-an-fda-panel-on-cmc-deficiencies-in-cder-blas/) - In the opening session of the August Duke-Margolis meeting on “Continual Improvement of CDER BLA Submission, Assessment, and Facility Readiness/Inspection: CMC for Biologics & Biosimilars,” three CDER officials provided an analysis of trends in Complete Response Letters (CRLs) for Biologics License Applications (BLAs). Participating in the CDER presentation were: ● Center Director Patrizia Cavazzoni, who introduced the topic and issues involved ● Senior Pharmaceutical Quality Assessor Max Van Tassel, who explored the facility deficiencies identified in the CRLs, and ● Lead Interdisciplinary Scientist Brian Roelofs, who focused on the process control issues involved.
- [Week Ending August 16, 2024: Featuring a Regulator Panel on Comparability for Cell-Based Therapies](https://ipq.org/week-ending-august-16-2024-featuring-a-regulator-panel-on-comparability-for-cell-based-therapies/) - At the June 2024 CASSS CGTP Summit, a panel of experts from key agencies focused on the current issues that are arising related to assuring comparability for cell-based medicinal products and the path to a harmonized regulatory approach in addressing them. Participating in the panel were: ● Swedish Medical Products Agency Senior Assessor Andreea Barbu ● PMDA Office of Cellular and Tissue-Based Products Director Yoshiaki Maruyama ● Health Canada Gene Therapies Senior Quality Evaluator Christopher Storbeck, and ● FDA CBER Gene Therapy CMC Reviewer Andrew Timmons. The moderators/co-chairs were Kite Pharma Regulatory CMC Head Bita Badiei and consultant Margarida Menezes Ferreira, who was formerly a Senior Assessor in Portugal’s Infarmed. An introduction was provided by the third session co-chair, Sana CMC Regulatory CGT Leader Deep Shah.
- [Expanding Regulatory Guidance and Standards Support for Peptides and Oligonucleotides in Focus at USP Workshop](https://ipq.org/expanding-regulatory-guidance-and-standards-support-for-peptides-and-oligonucleotides-in-focus-at-usp-workshop/) - Increasing experience in developing and reviewing synthetic peptide and oligonucleotide therapeutics is providing the foundation for more concrete guidance and standards for these rapidly expanding product classes. Peptides and oligos present unique regulatory challenges that may not be covered under the guidance and support umbrella in place for either conventional small molecule or biological products. They are complex molecules that are prone to impurities and are difficult to synthesize and characterize. The rapid innovations in the field, including novel modifications, new formulations, and the emergence of platform technologies, are also a challenge to keep pace with.
- [A Confluence of Forces Is Now Spurring Combination Product Regulatory Reform in Europe](https://ipq.org/a-confluence-of-forces-is-now-spurring-combination-product-regulatory-reform-in-europe/) - A confluence of forces is intensifying the pressure on and opening pathways to the reform of drug/device combination product regulation in Europe, with legislative changes and strategic priority needs at issue. Part I: EU Pharma Strategy Roadmap, Comments from Industry, and Related Agency Strategies Part II: Culture/Structure/Process Change and Global Alignment Part III: HPRA CEO Lorraine Nolan on HPRA and EMA Strategy Part IV: EMA’s Zaïde Frias and NB/Industry Perspectives on EU Regulatory Transformation
- [Academia/Industry Collaboration Intensifies on Addressing the Pressing Needs in Biopharma Workforce Development](https://ipq.org/academia-industry-collaboration-intensifies-on-addressing-the-pressing-needs-in-biopharma-workforce-development/) - Academia and industry are collaborating more intensely on addressing the pressing needs in biopharma workforce development, in recognition of the challenges of keeping pace with the rapidly evolving process and product technologies and the cross-functional understanding and skills needed to support them. Part I: NIIMBL’s Engagement with Academia on Workforce Development Needs Part II: ISPE Workforce of the Future Traction at UMBC and UC Davis Part III: Keck Institute’s Behrens on Biopharma Talent Needs and KGI/Industry Partnering Part IV: Xavier’s Phillips on Sharable Quality and Regulatory Science Curriculum Part V: CASSS Panel on Opening Up Biopharma Career Pathways Part VI: European and Global Workforce Development Collaborations
- [Regulators Share Pandemic’s CMC Impact at CASSS Japan Forum; Guidance Output Continues Apace in Q1 2021](https://ipq.org/regulators-share-pandemics-cmc-impact-at-casss-japan-forum-guidance-output-continues-apace-in-q1-2021/) - This four-part story explores the significant impact of the pandemic during 2020-2021 on the CMC review processes for vaccines and biotherapeutics at FDA, EMA and Japan’s PMDA in their efforts to support accelerated product development and review, while assuring that quality standards are met and the ongoing non-COVID-related workload addressed. Part I: EMA Perspective Part II: FDA CBER Perspective Part III: FDA CDER Perspective Part IV: Panel Discussion Among US, Europe, and Japan Regulators
- [Regulators Are Exploring with Industry How to Strengthen Quality Risk Management Practices, with Revision of ICH Q9 a Key Focal Point](https://ipq.org/regulators-are-exploring-with-industry-how-to-strengthen-quality-risk-management-practices-with-a-revision-of-ich-q9-among-the-focal-points/) - Regulators and industry are sitting down together to mine their experience and map out some clearer directions and expectations about what is needed to empower quality risk management (QRM) in improving the pharmaceutical quality system (PQS) and the industry/regulatory communication process at the review and inspection levels. Part I: ICH Q9 Revision Lead O’Donnell on the Evolution of QRM Part II: FDA’s Rick Friedman on Advancing Aseptic Processing through QRM Part III: Industry/Academia Thought Leaders on the Evolving QRM/KM Relationship
- [Pandemic Urgencies Highlight Constraints in Manufacturing Change Regulatory Paradigm and Where Adjustments Are Needed](https://ipq.org/pandemic-urgencies-highlight-constraints-in-manufacturing-change-regulatory-paradigm-and-where-adjustments-are-needed/) - The pressing need during the COVID-19 pandemic to accelerate product development and rapidly accommodate the shifting manufacturing and distribution demands has shed strong light on the constraints in the existing quality regulatory framework and the pathways to reducing them. Part I: Industry Quality Leaders on the Global PAC Regulatory Problem and Solutions Part II: Evolving the Quality Regulatory Paradigm at the Global Level
- [Manufacturing, Impurities, and Characterization Methods Are Key Regulatory Focal Points for Peptides and Oligonucleotides](https://ipq.org/manufacturing-impurities-and-characterization-methods-are-key-regulatory-focal-points-for-peptides-and-oligos/) - The manufacturing process, the control of impurities – in the starting materials, the API and the drug product – and the analytical methods for characterization are focal points for regulators during CMC reviews of both synthetic peptide and oligonucleotide (oligo) therapeutics. Part I: Recent CMC/Regulatory Challenges of Oligonucleotide Drugs Part II: Comparability Challenges in Crossing Over to Generics Part III: Comparing Peptide and Oligonucleotide CMC Issues Part IV: Starting Material Specifications for Oligonucleotides
- [Biomanufacturer Raw Material Control on Regulatory Front Burner as Analytical Power and Formulation Challenges Intensify](https://ipq.org/biomanufacturer-raw-material-control-on-regulatory-front-burner-as-analytical-power-and-formulation-challenges-intensify/) - A more powerful analytical toolbox is allowing industry and regulators to better understand how biotech product manufacturers can improve the control strategies for the raw materials they are using. However, there are still significant knowledge and control gaps, and experts from industry, regulatory agencies, and pharmacopeias are actively sharing insights on how best to fill them. Part I: Biotech Regulator Vantage Point on Raw Material Control Part II: The Added Challenges of Materials Management for CGTs Part III: Biomanufacturer Use and Control of Polysorbates
- [COVID Vaccine Industry Project Leaders Are Sharing Insights on How the Daunting CMC Challenges Were Addressed](https://ipq.org/covid-vaccine-industry-project-leaders-are-sharing-insights-on-how-the-daunting-challenges-were-addressed-and-the-learnings/) - The leaders of industry’s major COVID vaccine efforts have been sharing their insights at recent conferences on: ● how their companies managed to address the daunting development, manufacturing, and supply chain challenges involved in delivering a vaccine in unprecedented speed during a pandemic, and ● the lessons that can be garnered from that experience in moving forward. Part I: Implementing the Pfizer/BioNTech mRNA Vaccine Development Plan Part II: New Digitalized Facility as Springboard for Moderna’s mRNA Vaccine Part III: Oxford University/AZ Partnership for Global Adenovirus Vaccine Access Part IV: J&J’s Experience in Handling the Supply Chain Challenges Part V: Novavax’s Approach to Assuring Comparability for its Protein-based Vaccine Part VI: Inter-Company Panels at DIA and ISPE Meetings on Vaccine Experience
- [USP and Ph. Eur. Initiatives in the Biologics Arena Continue to Bear Fruit; FDA Joins the Pharmacopeias in Upgrading Particulate Guidance](https://ipq.org/usp-and-ph-eur-initiatives-in-the-biologics-arena-continue-to-bear-fruit-fda-joins-the-pharmacopeias-in-upgrading-particulate-guidance/) - The emerging biotech product modalities and their complex analytical challenges and needs have led USP and the European Pharmacopoeia to adapt their standard-setting approaches and work collaboratively with stakeholders internationally in setting and pursuing priorities. Part I: Update on USP’s Evolving Role and Current Initiatives In the Biologics Arena Part II: European Pharmacopoeia and FDA Join USP in Focusing on Particulate Control
- [Key GMP Focal Points in Europe Include Guidance Revisions, New Vet Regulations, and Adaptive Assessment/Inspection Approaches](https://ipq.org/key-gmp-focal-points-in-europe-include-guidance-revisions-new-vet-regulations-and-adaptive-assessment-inspection-approaches/) - Key focal points in the European GMP arena include revisions to guidance, new veterinary medicine regulations, and adapting assessment/inspection processes to enable manufacturing through the COVID pandemic, foster international collaboration, and address point-of-care manufacturing. Part I: Update on EMA GMP-related Activities Part II: MHRA Innovation Pathway and Proposal for Point-of-Care Regulatory Framework Part III: Insights from Europe and ICMRA Regarding Onsite Inspection Alternatives
- [FDA’s KASA and Related PQ/CMC Initiatives on Improving CMC Data Structuring and Sharing Will Help Support ICH M4Q Revision](https://ipq.org/fdas-kasa-and-related-pq-cmc-initiatives-on-improving-cmc-data-structuring-and-sharing-will-help-support-ich-m4q-revision/) - FDA’s Knowledge-aided Assessment and Structured Application (KASA) and related Product Quality/CMC (PQ/CMC) initiatives have been laying some important conceptual and information technology (IT) groundwork for the ICH effort now underway to revise its M4Q guideline on the quality component of the Common Technical Document (CTD). Part I: The Advancing Knowledge-aided Assessment Component of KASA Part II: Bringing Biologics into the KASA System Part III: The Progress of FDA’s PQ/CMC Initiative Part IV: The Goals of Accumulus Synergy in CMC Data IT and Regulatory Communication Part V: The Drivers for Revising ICH M4Q and Evolving the CMC Regulatory Process
- [Janet Woodcock and Jeff Baker will Continue to Play Key Manufacturing Innovation Roles in New FDA and NIIMBL Positions](https://ipq.org/janet-woodcock-and-jeff-baker-will-continue-to-play-key-manufacturing-innovation-roles-in-new-fda-and-niimbl-positions/) - In her new role as FDA’s Principal Deputy Commissioner, Janet Woodcock will be able to continue her strong contribution to the effort in the US and around the world to make drug and biologic regulatory processes as supportive as possible of manufacturing innovation.
- [Pandemic Experience and Supply-Chain Risk Management Expectations Increase Attention on Excipient GMP Third-Party Auditing](https://ipq.org/pandemic-experience-and-supply-chain-risk-management-expectations-increase-profile-of-excipient-third-party-auditing/) - The pandemic experience and the increasing expectations of regulators regarding supply chain visibility and risk-management are driving forces for incorporating more third-party auditing of excipient suppliers into user quality management systems.
- [Progress in Addressing Impurity Challenges in Focus at USP’s 2022 Peptide/Oligo Workshop](https://ipq.org/progress-in-addressing-impurity-challenges-in-focus-at-usps-2022-peptide-oligo-workshop/) - The progress in understanding and addressing the challenges of impurities was a key focal point of this year’s USP Therapeutic Peptides and Oligonucleotides Workshop, held virtually on February 28, March 2 and March 4, 2022. PART I: US and European Regulator Perspective on the CMC Challenges of Oligonucleotides PART II: USP Standards Development Efforts for Peptides and Oligos PART III: Peptide and Oligo Analytical, Manufacturing and Raw Material Considerations
- [Pandemic Experience Showcases the Potential for Faster Innovation, More Collaboration, and Workplace and Operations Modernization](https://ipq.org/pandemic-experience-showcases-the-potential-for-faster-innovation-more-collaboration-and-workplace-and-operations-modernization/) - The potential for faster innovation, and the power of collaboration and workplace and operations modernization are emerging into high relief as the assessment of the pandemic experience continues to deepen. Among recent venues where industry and regulators have come together to explore these themes was the February ISPE Facilities of the Future Conference. Focused on the dialogue that took place there, the IPQ story that follows is divided into three parts: PART I: The Evolving Landscape of Pharmaceutical Operations PART II: Government-Industry Collaboration in This and Future Pandemics PART III: Reducing the Cost of Vaccine Manufacturing for Broader LMIC Access
- [NASEM-Led Study for FDA is Helping Drive Industry/Regulator Agenda on Innovation Needs](https://ipq.org/nasem-led-study-for-fda-is-helping-drive-industry-regulator-agenda-on-innovation-needs/) - An FDA-commissioned study carried out through the National Academies of Sciences, Engineering, and Medicine (NASEM) is helping drive the industry/regulator agenda on advancing innovation in pharmaceutical manufacturing. PART I: The NASEM Study and FDA Reflections PART II: Existing Mechanisms to Enable Innovation PART III: Challenges and Opportunities PART IV: The Path Forward
- [mRNA-LNP Vaccines Spur Global Dialogue on Nanomaterial Standards and Regulatory Approaches](https://ipq.org/mrna-lipid-vaccines-drive-dialogue-on-appropriate-nanomaterial-standards-and-regulatory-approaches/) - The successful development of mRNA-lipid nanoparticle (LNP) vaccines to address the COVID-19 pandemic has highlighted the power of nanoparticle-based formulations in producing safe and efficacious medicinal products. Part I: Pfizer/BioNTech Lipid Challenges with mRNA-LNP COVID Vaccine Part II: FDA’s Novel Excipient Review Pilot Program and Nanomaterials Guidance Part III: USP’s Draft Guideline and Other Efforts on mRNA Vaccine Quality Part IV: The EDQM Nanomedicines Dialogue and WHO on Regulating mRNA Vaccine Quality Part V: Potency Assays for mRNA-LNP Vaccines
- [Strengthened European Regulator Support for Advanced Technologies Includes New EMA Quality Innovation Group](https://ipq.org/strengthened-european-regulator-support-for-advanced-technologies-includes-new-ema-quality-innovation-group/) - The experience of the pandemic has underscored the criticality of assuring that regulatory processes keep pace with innovation in the manufacturing and control arena and has spurred the efforts that were underway in Europe to assess the issues involved and implement the adaptations needed to address them. The three parts of the IPQ story review the progress of these efforts. Part I: Europe’s Focus on CMC Innovation and Agile Regulation Part II: Innovation Issues Explored at CASSS CMC Forum in Europe Part III: MHRA’s “New Era in Regulation”
- [CBER’s Advanced Technologies Program Growing Stronger with Increased Funding, Expertise, and Collaboration](https://ipq.org/cbers-advanced-technologies-program-growing-stronger-with-increased-funding-expertise-and-collaboration/) - CBER’S Advanced Technologies Program (ATP) is being strengthened through the expansion of internal and external funding, scientific and regulatory expertise, and collaborative support through the CBER Advanced Technologies Team (CATT). As part of its efforts to promote the adoption of advanced manufacturing, CATT has joined with CDER’s Emerging Technologies Team (ETT) to form the Center for the Advancement of Manufacturing Pharmaceuticals and Biopharmaceuticals (CAMPB). The Office of Regulatory Affairs and other centers are also expected to participate in the center’s activities.
- [EMA Toolbox on CMC Flexibilities has been Evolving to Incorporate Industry Input and Learnings from the Pandemic](https://ipq.org/ema-toolbox-on-cmc-flexibilities-has-been-evolving-to-incorporate-industry-input-and-learnings-from-the-pandemic/) - EMA’s “toolbox guidance on scientific elements and regulatory tools to support quality data packages” for priority medicines targeting unmet medical needs, released in April 2022, reflects extensive stakeholder input and will evolve further as experience and learnings from the pandemic are evaluated. Developed as an outcome of the 2018 joint EMA/FDA workshop on quality support to Priority Medicines (PRIME) and Breakthrough Therapy (BT) designated products, the guidance outlines the tools available in the EU to address the challenges in generating robust quality packages under accelerated conditions. It is applicable to small molecules, biological/biotech products, and advanced therapy medicinal products (ATMPs). The guidance was drafted, consulted on, and revised throughout the COVID pandemic. Part I: EMA Perspective on its Toolbox Guidance and OPEN Initiative Part II: Industry View on Efficiency Tools and CMC Flexibility Learnings from COVID Part III: Panel Discussion on Effective Tools for the Future
- [Week Ending August 9, 2024: Featuring FDA’s Byrnes on Potency Assurance for CGTs](https://ipq.org/week-ending-august-9-2024-featuring-fdas-byrnes-on-potency-assurance-for-cgts/) - At the mid-June 2024 CASSS Cell and Gene Therapy Products Symposium, CBER Division of Gene Therapy 1 Director Andrew Byrnes discussed potency assurance strategies for CGTs, with reference to FDA’s new draft potency assurance guidance and stakeholder comments on it as well as to the relevant sections of the recently released genome editing guidance. Included are Byrnes’ responses to questions he was asked during the Q&A, in which other speakers from the session participated.
- [IPQ Monthly Update – May/June 2024 in Review](https://ipq.org/ipq-monthly-update-may-june-2024-in-review/) - The May/June Monthly Update features the concluding part of IPQ’s in-depth exploration of ICH’s recent efforts in the quality arena. Part VI explores the intensified dialogue now taking place between industry and agency leaders on the challenges, opportunities and progress in using the tools and principles in the ICH Q12 lifecycle management guideline to advance the ICH objective of a more continuous improvement and innovation-friendly pharmaceutical quality regulatory environment. Also provided are “current insights from leading regulators” on: ● FDA’s CMC expectations for therapeutic peptides ● the role of the African Medicines Agency (AMA) in the continental regulatory system ● MHRA API and excipient inspection findings ● the regulator/industry vision for a global quality dossier ● regulatory expectations for computer software assurance ● the role of an executive-supported quality/operations partnership ● lifecycle management expectations for drug/device combination products ● adoption of the Annex 1 revision, and ● FDA on inspectional trends in aseptic manufacturing.
- [Week Ending August 2, 2024: Featuring EMA’s Jekerle on ATMP/Gene Therapy Challenges](https://ipq.org/week-ending-august-2-2024-featuring-emas-jekerle-on-atmp-gene-editing-product-challenges/) - At the June 2024 PDA Advanced Therapy Medicinal Product Conference, EMA Pharmaceutical Quality Head Veronika Jekerle discussed the interplay between EMA and sponsors in advancing ATMP product development – focusing, in particular, on gene therapies and the CMC challenges that need to be addressed for these products.
- [ICH’s 2003 Vision of a Harmonized Quality Regulatory Approach that Fosters Innovation Continued to Take Form in 2023 and 2024](https://ipq.org/ichs-2003-vision-of-a-harmonized-quality-regulatory-approach-that-fosters-innovation-continued-to-take-form-in-2023-and-2024/) - The ICH goal of evolving its quality guideline series to keep pace with and provide support for technological innovation has continued to be realized in 2023 and 2024. The goal is not a new one for ICH but was clearly articulated back in 2003 in an overarching “Quality Vision” calling for the development of “a harmonized pharmaceutical quality system applicable across the lifecycle of the product emphasizing an integrated approach to quality risk management and science.” ● PART I: Analytics Guidelines Q14 and Q2(R2) ● PART II: Viral Safety Guideline Q5A(R2) ● PART III: ICH Q1/Q5C Revision and Stability Evaluation ● PART IV: The Role of the New CGT Discussion Group ● PART V: ICH’s M4Q(R2) on the Quality Component of the CTD ● PART VI: The Implementation of ICH Q12
- [Week Ending July 26, 2024: Featuring EMA's Palmi on International Reliance](https://ipq.org/week-ending-july-26-2024-featuring-emas-palmi-on-international-reliance/) - At the June 2024 DIA Southeastern Europe Conference, EMA Senior International Affairs Officer Victoria Palmi Reig discussed how the EU processes and experience can help further international collaboration and reliance. She addressed: ● reliance and trust in the EU network ● a reliance toolkit for regulatory agencies ● how to utilize EMA assessment reports, and ● EMA assessment outputs for use in regulatory reliance.
- [Week Ending July 19, 2024: Featuring FDA CBER Reviewer Schulte on Deploying Rapid Microbial Methods](https://ipq.org/week-ending-july-19-2024-featuring-fda-cber-reviewer-schulte-on-deploying-rapid-microbial-methods/) - CBER reviewer and standards expert Seth Schulte gave a presentation on the evaluation and implementation of rapid microbial methods (RMMs) at the May 2024 FDA Regulatory Education (REdI) annual conference. He discussed: ● the RMM regulatory space ● RMM validation ● relevant compendial coverage and agency guidance, and ● common deficiencies observed with the development of RMMs. Companies that are deploying RMMs in product/process development or considering changing to them will find Schulte’s insights highly valuable.
- [Week Ending July 12, 2024: Featuring FDA Compliance Official Dionne on DEG/EG Enforcement](https://ipq.org/week-ending-july-12-2024-featuring-fda-compliance-official-dionne-on-deg-eg-enforcement/) - At the 2024 IPEC-Americas Excipient World conference held in May, CDER Compliance Officer Matthew Dionne discussed FDA’s work to counter the risk of diethylene and ethylene glycol (DEG/EG) contamination. After a brief reflection on his public health service, Dionne addressed: ● FDA’s regulatory authority and enforcement tools ● DEG/EG contamination events ● FDA’s actions in response to the events, and ● compliance actions related to FDA’s high-risk components initiative.
- [Weekly Supplement: Week Ending February 16, 2024](https://ipq.org/weekly-supplement-week-ending-february-16-2024/) - At the AAM Annual Meeting in early February, CDER Principal Deputy Director Jacqueline Corrigan-Curay reviewed the current regulatory developments and priorities in generics and biosimilars. She addressed: ● FDA efforts in generics and biosimilars during 2023 ● the generic drug science and research priorities for 2024 ● why industry/regulator communication is key and how to facilitate it ● global convergence efforts in the generics arena, and ● opportunities for improvement.
- [Week Ending July 5, 2024: Featuring EMA's Conocchia on Implementing the Annex 1 Revision](https://ipq.org/week-ending-july-5-2024-featuring-emas-conocchia-on-implementing-the-annex-1-revision/) - At the May 2024 PDA Good Aseptic Manufacturing Conference, EMA GMP Technical Lead Roberto Conocchia reviewed the international collaborative efforts to align on implementing the Annex 1 revisions, including those of EMA’s GMDP Inspectors Working Group and the PICS/EMA/WHO Joint Implementation Working Group.
- [IPQ Monthly Update – March/April 2024 in Review](https://ipq.org/ipq-monthly-update-march-april-2024-in-review/) - The ICH goal of evolving its quality guideline series to keep pace with and provide support for technological innovation has continued to be realized in 2023 and 2024. The March/April Monthly Update provides Parts IV and V of an exploration by IPQ of the key initiatives that are high on the ICH quality agenda since 2023, the progress that has been made in advancing them, and what remains to be done in guideline creation, revision, and implementation. The ICH projects that are explored in these two parts address: ● the role of the new Cell & Gene Therapy Discussion Group (CGTDG), and ● the ongoing revision of the M4Q guideline on the quality section of the Common Technical Document (CTD).
- [IPQ Monthly Update – January/February 2024 in Review](https://ipq.org/ipq-monthly-update-january-february-2024-in-review/) - The ICH goal of evolving its quality guideline series to keep pace with and provide support for technological innovation has continued to be realized in 2023 and 2024. The January/February Monthly Update provides the first three parts of an exploration by IPQ of the key initiatives that are high on the ICH quality agenda since 2003, the progress that has been made in advancing them, and what remains to be done in guideline creation, revision, and implementation. The ICH guideline projects that are explored in these three parts address: ● analytics (Q14 and Q2(R2)) ● viral safety (Q5A(R2)), and ● stability (Q1, Q5C).
- [Week Ending June 28, 2024: Featuring FDA Office of Compliance Official Higgins on Aseptic Manufacturing](https://ipq.org/week-ending-june-28-2024-featuring-fda-office-of-compliance-official-higgins-on-aseptic-manufacturing/) - At the May 2024 PDA Good Aseptic Manufacturing Conference, FDA drug compliance official Brooke Higgins discussed recent FDA inspectional trends in aseptic manufacturing. Higgins addressed three areas where the agency continues to see problems: ● aseptic technique ● cleanroom behaviors, and ● design of the aseptic processing area. She offered insights on learnings from FDA warning letters and the path forward.
- [Week Ending June 21, 2024: Featuring EU GMP Inspector Meissner on Annex 1 Implementation Findings](https://ipq.org/week-ending-june-21-2024-featuring-eu-gmp-inspector-meissner-on-annex-1-implementation-findings/) - At the May 2024 PDA Good Aseptic Manufacturing Conference, AGES GMP Inspector Christina Meissner reviewed the inspection experience and expectations regarding EU GMP Annex 1 implementation. She began by addressing quality risk management (QRM) principles in Annex 1 and the criteria of good versus bad risk analyses. She then discussed inspector expectations and findings related to: ● QRM ● the contamination control strategy (CCS) ● transfer of materials ● outdated facilities, and ● emerging technologies.
- [Week Ending June 14, 2024: Featuring EMA’s Bouygues on Drug/Device Combination Regulatory Challenges](https://ipq.org/week-ending-june-14-2024-featuring-emas-bouygues-on-drug-device-combination-regulatory-challenges/) - Featured in this Weekly Supplement is a review by EMA’s Christelle Bouygues at the recent RAPs Euro Convergence Conference of the challenges that have come to the forefront in implementing Medical Device Regulation (MDR) Article 117 on drug/device combination products and how the Q&A addressing the regulatory expectations has been revised to help address them. She managed to cover a lot of ground in her concise talk on the state of play between regulators and industry on combination product approvals and life cycle management.
- [Industry is Urging EMA to Increase its Focus on Medicine Impact of EU Food, Chemical, and Environmental Legislation](https://ipq.org/industry-is-urging-ema-to-increase-its-focus-on-medicine-impact-of-eu-food-chemical-and-environmental-legislation/) - The European Federation of Pharmaceutical Industries and Associations (EFPIA) is stressing that food, chemical, and environmental legislation should be developed and implemented with the impact on medicines in mind and that EMA and other regulatory authorities and stakeholders need to be more directly engaged to make sure that the outcomes align with the EU’s healthcare objectives. PART I: The Need for Pharma Stakeholder Engagement PART II: EU PFAS Action and Pharma Mitigation Needs PART III: Industry and EMA on F-gases and Hydrofluorocarbons in Inhalation Products PART IV: DIA Europe Legislative Session Panel Discussio PART V: Intensified Industry Dialogue on TiO2 and Nanoparticles Ahead of More EMA Review
- [ICH Q3D Implementation Continues with Workshops, Research, and Guideline and Pharmacopeial Revisions](https://ipq.org/ich-q3d-implementation-continues-with-workshops-research-and-guideline-and-pharmacopeial-revisions/) - More sensitive and selective methodologies have facilitated the identification and quantification of elemental impurities (EIs) in pharmaceuticals and the movement away from the old heavy metal analytical tests to the newer risk-based assessment strategy of ICH Q3D. Part I: Role of PQRI/FDA Workshop in Q3D Implementation Dialogue Part II: Regulatory Experience and Perspectives in Implementing Q3D Part III: Pharmacopeial Harmonization with ICH Q3D Part IV: Outcomes of PQRI Study on Variability in Elemental Impurity Analysis
- [Government/Industry/Academia Collaborative Efforts to De-Risk and Accelerate Manufacturing Innovation Draw Strength from Pandemic Learnings](https://ipq.org/government-industry-academia-collaborative-efforts-to-de-risk-and-accelerate-manufacturing-innovation-draw-strength-on-pandemic-learnings/) - The US government is continuing to strengthen its collaborative efforts with industry and academia to de-risk and accelerate manufacturing innovation, as the learnings from the pandemic are further digested. The five-part IPQ story provides a wealth of insights from key leaders and policy makers on the innovation issues at play and how NIIMBL and other organizations are seeking to address them in the US and internationally. Part I: NIIMBL and its “Going First Together” Mantra Part II: US Manufacturing Innovation Leaders Weigh In Part III: The Importance of Process and Facility Innovation in Global Health Part IV: Charting the Advanced Therapy CMC Pathways and Other NIIMBL Projects Part V: CBER’s Marks on Taking CGTs to the Next Level
- [USP Continues to Refine Its Strategies for Keeping Pace with and Supporting the Rapidly Advancing Biotechnology in the MAb, Vaccine and CGT Arenas](https://ipq.org/usp-continues-to-refine-its-strategies-for-keeping-pace-with-and-supporting-the-rapidly-advancing-biotechnology-in-the-mab-vaccine-and-cgt-arenas/) - USP is continuing to evolve and refine its strategies for providing standards that can keep pace with and support the rapid advances in biotechnology taking place across the monoclonal antibody (mAb), vaccine, and the cell and gene therapy (CGT) landscape. Part I: USP Bio Stakeholder Forum Opening Remarks and Mass Spec Standards for Proteins Part II: USP's CGT Initiatives Part III: FDA and Industry Experience with CAR T Potency Testing Part IV: Update on USP Strategies and Initiatives in the MAb, Vaccine, and CGT Arena
- [Implementing ICH Q9(R1) Will Entail a Heightened Focus on Integrating Knowledge into Risk-Based Decision-Making](https://ipq.org/implementing-ich-q9r1-will-entail-a-heightened-focus-on-knowledge-management-and-risk-based-decision-making/) - Full implementation of the revisions that have been made to ICH’s Q9 guideline on quality risk management (QRM) will entail a heightened focus on how to best integrate knowledge into risk-based decision-making (RBDM) and is expected to be a mid-term rather than short-term project, according to the rapporteur and members of the guideline revision Expert Working Group (EWG). PART I: Insights from Expert Working Group Members on ICH Q9 Revisions PART II: Panel Discussion Among PRST Meeting KM/QRM Experts PART III: Risk-Based Decision-Making PART IV: Risk Management in Drug Shortage Prevention
- [CMC Innovation Support Programs Advance at EMA and FDA, with Distributed and Continuous Manufacturing on Front Burner](https://ipq.org/cmc-innovation-support-programs-advance-at-ema-and-fda-with-distributed-and-continuous-manufacturing-on-front-burner/) - The advancing CMC innovation support programs at EMA and FDA are highly complementary in focus and structure, with distributed and continuous manufacturing drawing significant up-front attention at both agencies. On both sides of the Atlantic, a significant effort is underway to deepen the regulator/industry/academia communication needed to realize the potential for technological advancement in the manufacturing and control arena. In this four-part story, IPQ explores the latest advancements in the EMA and FDA innovation support programs and the priorities that are now drawing front-burner attention. PART I: European Regulatory Network Support for Manufacturing Innovation PART II: FDA’s Expanding Engagement with Advanced Technologies PART III: Barriers to CM Adoption Explored at USP/RAPS Workshop PART IV: Distributed/POC Manufacturing and the CMC/Quality Regulatory Paradigm
- [Week Ending June 7, 2024: Featuring CDER’s Friedman on Quality/Operations/Business Synergy](https://ipq.org/week-ending-june-7-2024-featuring-cders-friedman-on-quality-operations-business-synergy/) - The feature story in this Weekly Supplement provides insights from FDA drug compliance official Rick Friedman on the critical role of the partnership between quality and operations leaders – empowered by company executives – in assuring ongoing process and product control. Friedman offered the insights at a “Quality Business Leadership Summit” held at the Technological University of Dublin (TUD) on May 1.
- [Week Ending May 31, 2024: Featuring MHRA/FDA Panel on Computer Software Assurance](https://ipq.org/week-ending-may-31-2024-featuring-mhra-fda-panel-on-computer-software-assurance/) - At the ISPE Europe Annual Meeting, held in mid-April 2024 in Lisbon, Portugal, regulators from the US FDA and the UK Medicines and Healthcare products Regulatory Agency (MHRA) participated in a panel discussion on “computer software assurance,” which was part of a track at the meeting on Good Automated Manufacturing Practice (GAMP). The panel participants from MHRA were GMP Inspector Kevin Bailey and Control and Governance Inspection Risk Unit Manager Ian Jackson. Participating from FDA virtually were Center for Devices and Radiological Health (CDRH) Case for Quality Program Manager Francisco Vicenty and CDRH Policy Analyst Daniel Walter. Moderators for the panel were Ten Ten Consulting Director Heather Watson and Q-FINITY Senior Executive Consultant Frank Henrichmann in-person in Lisbon, and Compliance Group Corporate Development & Operations EVP Khaled Moussally, virtually from the US. Watson, Henrichmann, and Moussally are all members of the ISPE GAMP Steering Committee.
- [Week Ending May 24, 2024: Featuring HPRA CEO Nolan on the Global Quality Dossier](https://ipq.org/week-ending-may-24-2024-featuring-hpra-ceo-nolan-on-the-global-quality-dossier/) - At the Quality Business Leadership Summit in Dublin in early May, HPRA Chief Executive Lorraine Nolan gave an opening keynote presentation on international collaborative efforts to develop a global quality dossier. She discussed: ● quality leadership in Ireland ● the background of the International Coalition of Medicines Regulatory Authorities (ICMRA) ● the development of a Pharmaceutical Quality Knowledge Management System (PQKMS) ● two collaborative post-approval change pilot studies, involving assessment and inspection, respectively ● future directions, and ● take-home messages.
- [Week Ending May 17, 2024: Featuring MHRA Inspector Watson on API & Excipient Findings](https://ipq.org/week-ending-may-17-2024-featuring-mhra-inspector-watson-on-api-excipient-findings/) - At the Joint Pharmaceutical Analysis Group (JPAG) conference on APIs and excipients held in London in late March, MHRA Lead Senior GMDP Inspector Trevor Watson shared his insights on current regulatory expectations and common inspection findings. He discussed: ● relevant UK and EU legislation for APIs ● inspection of API manufacturers ● API inspection findings between 2021-2023 ● GMP deficiency themes ● inspections of UK and overseas dosage form manufacturers ● common deficiencies in control of starting materials, and ● MHRA compliance referral processes.
- [The Challenges of Evolving Pharma from a Compliance to a Risk-Based Control Strategy Mindset Are Drawing Conference Spotlight](https://ipq.org/the-challenges-of-evolving-pharma-from-a-compliance-to-a-risk-based-control-strategy-mindset-are-drawing-conference-spotlight/) - The challenges of and drivers for evolving the pharmaceutical industry from a compliance-oriented mindset to one based on a control strategy embodying the risk management principles of ICH Q9(R1) are at the forefront of the industry/regulator dialogue at public forums, as the complexities of processes, products, and big data handling continue to expand. PART I: Critical Thinking in Risk Management and Data Governance PART II: Quality Culture/Oversight in Aseptic Operations PART III: Takeda’s Annex 1-Based Global CCS Program PART IV: QRM Tools in Root Cause Analysis PART V: Annex 1 Revisions and the CCS Implications
- [Weekly Supplement: Week Ending May 10, 2024](https://ipq.org/weekly-supplement-week-ending-may-10-2024/) - At the DIA Europe Conference, held in Brussels in mid-March, African Medicines Regulatory Harmonization (AMRH) Initiative Head Chimwemwe Chamdimba discussed: ● the background of the African Medicines Agency and the foundational role of the AMRH ● AMA key functions and current status ● ongoing AMRH technical support to the AMA ● continental processes, standards and guidelines, and ● reliance and regulatory system strengthening.
- [Weekly Supplement: Week Ending May 3, 2024](https://ipq.org/weekly-supplement-week-ending-may-3-2024/) - At the April 2024 USP Workshop on Peptide and Oligonucleotide Therapeutics, CDER OPQ Senior Pharmaceutical Quality Assessor Katharine Duncan presented on the agency’s CMC regulatory experiences and expectations for peptides. After an introduction to the product class, she explored the elements of a robust control strategy for peptide therapeutics, including: ● manufacturing process controls ● the characterization of peptides and their impurities ● specification setting and testing, and ● stability studies.
- [Weekly Supplement: Week Ending April 26, 2024](https://ipq.org/weekly-supplement-week-ending-april-26-2024/) - At the opening session of the 2024 USP peptide/oligo workshop, held at USP’s Rockville, Maryland headquarters in April, FDA Office of Pharmaceutical Quality (OPQ) Senior Pharmaceutical Quality Assessor Lawrence Perez discussed the CMC challenges the agency has been seeing in reviewing synthetic oligonucleotide therapeutics. His presentation covered: ● defining synthetic oligos, and the different classes that have been approved ● the specification of the API’s identity, purity, and assay, and ● manufacturing issues, including starting materials, API sameness for generics, and platform technologies.
- [Weekly Supplement: Week Ending April 19, 2024](https://ipq.org/weekly-supplement-week-ending-april-19-2024/) - During a WHO townhall session at the DIA Europe Conference, held in Brussels in mid-March, leaders from WHO and EMA explored the role the new WHO Listed Authorities (WLA) initiative will play in WHO’s global regulatory capacity strengthening efforts. Participants in the session included: ● WHO Regulatory Convergence and Networks Team Lead Samvel Azatyan, who introduced and moderated the session ● WHO Regulatory Systems Strengthening Team Lead Alireza Khadem Broojerdi, who spoke about the objectives and progress of the WLA initiative ● WHO Facilitated Product Introduction Team Lead Marie Valentin, who continued the discussion of WLA as a pathway to regulatory efficiency and reliance, and ● EMA International Department Head Martin Harvey Allchurch, who discussed EMA/EU support for and engagement with the WHO regulatory strengthening, collaboration and reliance efforts.
- [Weekly Supplement: Week Ending April 12, 2024](https://ipq.org/weekly-supplement-week-ending-april-12-2024/) - At the CDMO Workshop that followed the PDA Annual Meeting in late March 2024, FDA CBER Office of Cellular Therapy and Human Tissue CMC Deputy Director Steven Oh shared his insights on sponsor/CDMO relationships for CGTs and how they can be strengthened. He reviewed: ● the challenges in the manufacturing, logistics, and development spaces for CGTs, as well as ● actions that can be taken by the sponsors, CDMO’s, and collaboratively to address them.
- [Weekly Supplement: Week Ending April 5, 2024](https://ipq.org/weekly-supplement-week-ending-april-5-2024/) - At the DIA Europe Conference, held in Brussels in mid-March, MHRA Chief Partnerships Officer Glenn Wells gave an opening keynote presentation on the agency’s role in supporting sustainability and Net Zero goals. He discussed: ● British Pharmacopoeia sustainability initiatives ● UK medical device regulation provisions ● the role of MHRA and its place in the UK system for healthcare and sustainability, and ● national and international collaboration.
- [Weekly Supplement: Week Ending March 29, 2024](https://ipq.org/weekly-supplement-week-ending-march-29-2024/) - At the DIA Europe Conference, held in Brussels in mid-March, FDA held a “Townhall” session where Office of the Commissioner (OC) Office of Global Policy and Strategy (OGPS) leaders spoke about the collaboration with EMA and the work of FDA’s foreign offices, including the European Office. Participating in the session were FDA Liaison to the EMA Katherine Tyner, who introduced the session and discussed her role at EMA, and FDA Europe Office staff: ● Director Katie Serrano, who gave an overview of the office ● Deputy Director Shannon Thor, who spoke about the office’s priorities for 2024, and ● Senior Policy Advisor Ioana Ulea, who moderated the Q&A panel discussion and gave a brief summary of the session.
- [Weekly Supplement: Week Ending March 22, 2024](https://ipq.org/weekly-supplement-week-ending-march-22-2024/) - At the DIA/RAPS Summit on Combination Products in the EU, held in Brussels at the end of January, European Commission Policy Officers Olga Tkachenko and Isabelle Clamou gave a joint presentation on the EC-led “COMBINE” project, which is analyzing the regulatory landscape for clinical studies involving medicinal products used in combination with medical devices and/or in vitro diagnostics.
- [Weekly Supplement: Week Ending March 15, 2024](https://ipq.org/weekly-supplement-week-ending-march-15-2024/) - At the February 22, 2024 Regional ICH Consultation Webinar cosponsored by FDA and Health Canada, HC Cell, Gene Therapies, and Radiopharmaceuticals Division Senior Quality Evaluator Chris Storbeck provided an update on the current status of the ICH Q5A(R2) guideline “Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin.” Storbeck served on the Q5A(R2) Expert Working Group (EWG) and is now on the follow up Implementation Working Group (IWG).
- [Weekly Supplement: Week Ending January 26, 2024](https://ipq.org/weekly-supplement-january-26-2024/) - At the late November 2023 AFDO/RAPS Combination Products Summit, held in Fort Worth, Texas, the new Office of Combination Products (OCP) Director James Bertram, and Assistant Director John (Barr) Weiner gave a joint opening address on OCP’s strategic priorities and actions. Bertram began with updates on the OCP team and points of contact. Weiner then reviewed the progression over the past 30 years in FDA’s CP regulation and the strategies and opportunities for moving forward at FDA and internationally. Bertram concluded with updates on FY 2022 combination product data and OCP’s current and upcoming activities.
- [Weekly Supplement: Week Ending February 2, 2024](https://ipq.org/weekly-supplement-february-2-2024/) - EMA Head of Quality and Safety of Medicines Evdokia Korakianiti presented on the EU’s regulatory initiatives regarding digitalization at the December 2023 ISPE Pharma 4.0 and Annex 1 Conference. She addressed: ● digitalization benefits and regulatory challenges ● the three pillars of the EU digitalization framework – legislative activities, the EMA AI reflection paper, and the Quality Innovation Group (QIG) ● takeaways from the October 2023 digitalization “listen-and learn focus group” (LLFG), and ● other current and future QIG activities.
- [Weekly Supplement: Week Ending February 9, 2024](https://ipq.org/weekly-supplement-february-9-2024/) - At the CASSS CMC Strategy Forum on in-use stability testing, held in Washington, D.C in late January in conjunction with CASSS’ Well Characterized Biological Products (WCBP) Conference, Health Canada Senior Biologist/Evaluator Paula Russell shared her insights on in-use stability testing. She addressed: ● the currently available guidance ● protocol design for in-use studies, and ● justifying risk-based approaches.
- [Weekly Supplement: Week Ending February 23, 2024](https://ipq.org/weekly-supplement-week-ending-february-23-2024/) - A panel session at the 2024 CASSS WCBP Conference brought together international regulatory leaders to discuss “transforming global regulatory CMC practices in an age of regulatory innovation.” The session began with summary remarks by each of the panelists on the engagement of their respective agencies/organization with the evolving CMC practices and international collaborative initiatives.
- [Weekly Supplement: Week Ending March 8, 2024](https://ipq.org/weekly-supplement-week-ending-march-8-2024/) - The ICH effort to revise and expand its quality guideline series to better facilitate the rapid advancement of process and product technology in the pharmaceutical arena continues to bear fruit with the completion of its new analytical development guideline Q14 and a significant revision of its analytical validation guideline Q2(R1). At a late-February ICH stakeholder consultation meeting co-sponsored by FDA and Health Canada, CDER Office of Testing Research Director David Keire, who has been serving as the ICH Q2(R2)/Q14 Regulatory Chair, highlighted key aspects of the two guidelines and how they support analytical advancement.
- [Weekly Supplement: Week Ending March 1, 2024](https://ipq.org/weekly-supplement-week-ending-march-1-2024/) - A panel session at the 2024 CASSS WCBP Conference brought together international regulatory leaders to discuss “transforming global regulatory CMC practices in an age of regulatory innovation.” The session began with summary remarks by each of the panelists on the engagement of their respective agencies/ organization with the evolving CMC practices and international collaborative initiatives, which appeared in the February 26 Weekly Supplement. A Q&A discussion followed, which is featured in Part II of the story provided in this issue.
- [IPQ Monthly Update – November/December 2023 in Review](https://ipq.org/ipq-monthly-update-november-december-2023-in-review/) - Receiving heightened attention at conferences taking place during the later part of 2023 was the paradigm shift that has been gaining momentum in pharma away from a compliance-oriented mindset toward taking on the deeper challenge of figuring out how to manage the quality risks and uncertainties of highly complex processes and products and the vast amount of data that the advancing analytical technology now delivers on them. The five-part story featured in our November/December Monthly Update provides an in-depth analysis of how these complexities are driving a more control strategy-based approach embodying the risk management principles of the revised versions of ICH Q9 and Annex 1.
- [Gates Foundation’s Expanded Commitment to Global Medicines Encompasses CMC/Regulatory Problem Solving](https://ipq.org/gates-foundations-expanded-commitment-to-global-medicines-encompasses-cmc-regulatory-problem-solving/) - The Bill & Melinda Gates Foundation is stepping up its commitment to helping solve the complex chemistry, manufacturing and control (CMC), regulatory, financial, and distribution challenges of providing quality medicines for developing countries.
- [COVID-19 Vaccine Urgency Throws Spotlight on Next-Gen Sequencing as Key Facilitator](https://ipq.org/covid-19-vaccine-urgency-throws-spotlight-on-next-gen-sequencing-as-key-facilitator/) - The urgency of delivering a vaccine for COVID-19 in previously unattainable timeframes and volumes is throwing the spotlight on the expanded role next-generation sequencing (NGS) needs to play to avoid the time delays and other limitations of in vivo/animal testing. PART I: Adventitious Agent Testing in Focus at CASSS CMC Forum Europe PART II: Sanofi Pasteur and Ghent University Experience with NGS PART III: A Decade of Regulator/Industry Collaboration on NGS PART IV: Stakeholder Engagement Begins on ICH Q5A Revision PART V: Effort to Reduce Animal Testing for Vaccines Includes Global Health Fund Support for NGS
- [Attention Heightens on Creating an Independent Regulatory Pathway for Introducing Novel Excipients](https://ipq.org/attention-heightens-on-creating-an-independent-regulatory-pathway-for-introducing-novel-excipients/) - IPQ’s five part series is exploring the need for: ● a more qualified-for-purpose excipient toolbox that can help address the formulation, quality, and manufacturing challenges posed by a new generation of medicines, and ● a regulatory process that can better accommodate novel excipients. INTRODUCTION PART I: FDA’S Novel Excipient Program Proposal and Stakeholder Comments PART II: IPEC/IQ Thought Leaders on the Novel Excipient Drivers PART III: Subcutaneous Biotherapeutics, Pediatrics, and Delayed Release PART IV: USP Initiatives Supporting Novel Excipient Development PART V: Assessing and Managing Excipient Risks
- [Latest Improvements in FDA’s Inactive Ingredient Database Include Change Log and Use of Maximum Daily Exposure](https://ipq.org/latest-improvements-in-fdas-inactive-ingredient-database-include-change-log-and-use-of-maximum-daily-exposure/) - FDA’s latest efforts to improve the functionality of its Inactive Ingredient Database (IID) include a quarterly log to track changes in the records and the use of the term “maximum daily exposure” (MDE) in lieu of “maximum potency.”
- [Pandemic Spurs Deepening of Pharmacopoeia/Regulator/Industry Communication Channels](https://ipq.org/pandemic-spurs-deepening-of-pharmacopoeia-regulator-industry-communication-channels/) - The pandemic is prompting all of those involved in medicine production, regulation, and standards-setting to take a hard look at their operations for how they can be: ● adapted to continue being productive and address the pandemic exigencies, as well as ● potentially improved on a longer-term basis. It is also significantly deepening communication and cooperation channels. Part I: EDQM Pandemic Actions Continue Apace in Fall 2020 Part II: Pharmacopeia, Regulator and Industry Expert Panel Explores Pandemic and Nitrosamine Communications Part III: Second Panel Focuses on Pandemic Organizational Impacts and Key Learnings Part IV: EDQM and Ph. Eur. Evolution Addressed by Leaders Keitel and Vielle
- [IPQ Monthly Update – September/October 2023 in Review](https://ipq.org/ipq-monthly-update-september-october-2023-in-review/) - The advancing CMC innovation support programs at EMA and FDA are highly complementary in focus and structure, with distributed and continuous manufacturing drawing significant up-front attention at both agencies. The four-part story featured in IPQ’s September/October Monthly Update explores the significant effort underway to deepen the regulator/industry/academia communication needed to realize the potential for technological advancement in the manufacturing and control arena, and in CM and DM in particular.
- [IPQ Monthly Update – July/August 2023 in Review](https://ipq.org/ipq-monthly-update-july-august-in-review/) - Regulator and industry understanding and implementation of quality risk management in drug manufacturing and control has been advancing and ICH has revised its QRM guideline Q9 accordingly. The four-part story featured in IPQ’s July/August Monthly Update includes insights from the rapporteur and other Expert Working Group members involved in drafting the revisions – as well as from other QRM experts – on the issues addressed and the implementation expectations and challenges. Parts III and IV of the story home in on two of the areas drawing attention in Q9(R1) – risk-based decision-making and product availability risks, respectively.
- [IPQ Monthly Update – May/June 2023 in Review](https://ipq.org/ipq-monthly-update-may-june-2023-in-review/) - The first of the two interrelated stories featured in our May/June Monthly Update focuses on titanium dioxide (TiO2) as a good case study of the layers of challenges that come into play as food, chemical, and environmental concerns get translated into the medicines arena. The second five-part story delves more broadly into the challenges of designing and implementing constructive and viable environmental policies that do not carry with them unintended consequences for medicines. The parts explore: ● the need for pharma stakeholder engagement ● EU PFAS action and pharma mitigation needs ● F-gases and hydrofluorocarbons in inhalation products ● a DIA Europe legislative session panel discussion, and ● the TiO2/nanoparticle dialogue at a June PQRI workshop.
- [IPQ Monthly Update – January/February 2023 in Review](https://ipq.org/ipq-monthly-update-january-february-in-review/) - The story featured in IPQ’s January/February Monthly Update explores how the US government is continuing to strengthen its collaborative efforts with industry and academia to de-risk and accelerate manufacturing innovation as the learnings from the pandemic get further digested. The five-part story provides a wealth of insights from key leaders and policy makers on the innovation issues at play and how the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) and other organizations are seeking to address them in the US and internationally.
- [IPQ Monthly Update – March/April 2023 in Review](https://ipq.org/ipq-monthly-update-march-april-in-review/) - Developing standards in a fast-moving arena like biotechnology is a challenging task. The four-part feature story in IPQ’s Monthly Update for March and April explores what USP has been able to achieve and where it is looking to expand its contribution, in collaboration with industry, government and academic stakeholders, through a “solutions-based” approach that focuses on the development of standards addressing assay and process performance. Also shared is what CBER reviewers are seeing and advising in reviewing CGT CMC applications – in particular, regarding the challenges of potency testing for CAR T cell therapies.
- [IPEC is Helping Marshal Expertise Across Stakeholders to Forestall a Potential Titanium Dioxide Ban in Pharmaceuticals](https://ipq.org/ipec-is-helping-marshal-expertise-across-stakeholders-to-forestall-a-potential-titanium-dioxide-ban-in-pharmaceuticals/) - The International Pharmaceutical Excipients Council (IPEC) is working with other groups of experts across the stakeholder community to prevent questionable safety concerns raised in Europe about the use of titanium dioxide in foods from resulting in a ban on its use in formulating drug products. Because of a link between food and pharma legislation in Europe, a January 2022 EU regulation removing titanium dioxide (TiO2) from the list of authorized food additives could result in it not being allowed in pharmaceuticals, unless a second review by the European Medicines Agency – to be completed by April 2024 – provides sufficient justification for its continued use. Industry input to the updated EMA review is due by November 2023. [To help expand awareness of the TiO2 issue and its implications, IPQ is making the full story openly available. Click here to read the story.]
- [CBER Advice on CGT Process and Facility Management Includes Early Consideration of Engineering and Capacity Needs](https://ipq.org/cber-advice-on-cgt-process-and-facility-management-includes-early-consideration-of-engineering-and-capacity-needs/) - As its experience grows with reviewing cell and gene therapy (CGT) processes, equipment and facilities, CBER is strongly recommending that firms start early in thinking about the engineering and capacity needs of a commercial facility.
- [USP Views Early Broad Stakeholder Engagement as Essential in Developing Performance-Based Standards for Biologics](https://ipq.org/usp-views-early-broad-stakeholder-engagement-as-essential-in-developing-performance-based-standards-for-biologics/) - The U.S. Pharmacopeia (USP) views expanded early engagement with key stakeholders through workshops, roundtable meetings/studies, and Pharmacopeial Forum (PF) Stimuli articles as an essential component in advancing performance-based standards for biologic products.
- [The Processing and Formulation Complexities of Therapeutic Biologics Compel Heightened Focus on Excipient Needs](https://ipq.org/the-processing-and-formulation-complexities-of-therapeutic-biologics-compel-heightened-focus-on-excipient-needs/) - The processing and formulation complexities of the new generation of therapeutic biologics are compelling industry and regulators to take a hard look at the risks and requirements of the raw materials and excipients involved.
- [Industry Experience with Autologous Cell Therapies Underscores Need for Upfront Planning on Integrating Facility Design, Operations, and Supply Lines](https://ipq.org/industry-experience-with-autologous-cell-therapies-underscores-need-for-upfront-planning-on-integrating-facility-design-operations-and-supply-lines/) - Industry experience with autologous cell therapies is matching up with that of regulators in underscoring the importance of comprehensive integrated planning – encompassing internal operations and facility design as well as the complexities of the supply chain – to be able to meet future capacity needs.
- [IPQ Monthly Update – September/October 2019 in Review](https://ipq.org/ipq-monthly-update-september-october-2019-in-review/) - The issue begins with an exploration of how USP is evolving its standard setting approach for the new generation of biologic products and processes, and follows with a complementary review of the challenges in raw material and excipient use in biologics, in particular. The next two stories focus on the regulator and industry learnings, respectively, in gaining experience with the unique considerations that cell and gene therapies present in facility and operation management.
- [FDA and Industry Quality Metrics Initiatives Are Paving the Way to Manufacturing and Regulatory Advancements](https://ipq.org/fda-and-industry-quality-metrics-initiatives-are-paving-the-way-to-manufacturing-and-regulatory-advancements/) - Three FDA quality metrics initiatives – involving site visits, industry feedback, and academic research – are expanding the understanding of how metrics can be most effective in advancing pharmaceutical quality and culture and preventing process failures and product shortages, while streamlining regulatory oversight.
- [CDRH Case for Quality Voluntary Improvement Pilot Collaboration Shows Impressive Results for Device Manufacturers](https://ipq.org/cdrh-case-for-quality-voluntary-improvement-pilot-collaboration-shows-impressive-results-for-device-manufacturers/) - FDA’s Center for Devices and Radiological Health (CDRH) expects to fully implement its “Voluntary Manufacturing and Product Quality” program in 2020, following a positive experience during the pilot phase of this highly collaborative alternative to traditional agency inspections.
- [IPQ Monthly Update – November 2019 in Review](https://ipq.org/ipq-monthly-update-november-2019-in-review/) - In this issue, IPQ explores the prominent FDA and industry association initiatives that are active in the quality metrics and culture arena – how they are progressing, how they interrelate, their impact, and the learnings they are providing. The first story focuses on the initiatives taking place on the pharma side, while the second shifts to the implementation of the Center for Devices' highly relevant Case for Quality and voluntary improvement pilot programs.
- [International Mutual Inspection Recognition Expands with ASEAN Accrediting Philippines Using PIC/S Criteria](https://ipq.org/international-mutual-inspection-recognition-expands-with-asean-accrediting-philippines-using-pic-s-criteria/) - The FDA Philippines (FDAP) has been approved to join the regulatory agencies of Singapore, Malaysia, Indonesia, and Thailand on the Association of Southeast Asian Nations (ASEAN) Listed Inspection Services (LIS), after an extended review process that included documentary, on-site, and in-process inspection assessment.
- [US/EU MRA Implementation, US Congressional Hearings, and Industry Surveys Shed Light on Global GMP Inspection Challenges and Collaboration Opportunities](https://ipq.org/us-eu-mra-implementation-us-congressional-hearings-and-industry-surveys-shed-light-on-global-gmp-inspection-challenges-and-collaboration-opportunities/) - During the past decade, industry and regulators around the world have been heavily focused on addressing the daunting challenges of assuring the quality of medicines across an increasingly globalized supply chain.
- [IPQ Monthly Update – December 2019 in Review](https://ipq.org/ipq-monthly-update-december-2019-in-review/) - The December issue explores the collaborative efforts in which industry and regulators are now engaged to address the challenges of assuring the quality and availability of medicines across an increasingly globalized supply chain. The first story reviews various components of the progress that is being made in inspection-related information, standards and resource sharing – with a focus on the US and Europe, in particular – while the second shifts the focus to the Southeast Asia regional efforts going on through ASEAN.
- [IPQ Monthly Update – January/February 2020 in Review](https://ipq.org/35826-2/) - In this issue, IPQ explores the need for excipients that are fit-for-purpose in meeting the complex challenges of formulating, manufacturing, and delivering the new generation of medicines and making them as safe, efficacious, and patient- and distribution-friendly as possible. The five parts of the story focus on: ● a novel excipient review proposal from FDA and stakeholder comments ● industry thought leaders on the novel excipient drivers ● the issues involving subcutaneous biotherapeutics, pediatrics, and delayed release ● USP initiatives supporting novel excipient development, and ● assessing and managing excipient risks.
- [Existing Accelerated CMC, Advanced Manufacturing, and Inspection Initiatives are Supporting Regulators in Pandemic Response, FDA’s Cruse Explains in Recent Field Office Updates](https://ipq.org/existing-accelerated-cmc-advanced-manufacturing-and-inspection-initiatives-are-supporting-regulators-in-pandemic-response-fdas-cruse-explains-in-recent-field-office-updates/) - Initiatives that the major regulatory agencies have been advancing to help address the CMC and technology challenges of developing complex medicines under accelerated timelines are creating a critical foundation for responding to the current coronavirus pandemic.
- [Top FDA Drug Compliance Concerns during 2019 Included OTCs, Supply Chain Information Flow, Compounding, and Genotoxic Impurities](https://ipq.org/top-fda-drug-compliance-concerns-during-2019-included-otcs-supply-chain-information-flow-compounding-and-genotoxic-impurities/) - Over-the-counter (OTC) drugs – from raw material supply through product manufacturing and distribution – remained a central concern at the FDA Center for Drug Evaluation and Research (CDER) Office of Compliance (OC) during 2019.
- [IPQ Monthly Update – March 2020 in Review](https://ipq.org/ipq-monthly-update-march-2020-in-review/) - The first story in the March Monthly Update explores recent FDA global field inspection and enforcement operations. In focus are: ● the impact of the pandemic ● the field office’s API and drug product inventory and enforcement tools ● recent warning letter and import alert data and trends, and ● progress on the goals of reducing the timelines for inspection classification/notification and warning letter issuance. The following story provides insights from FDA’s drug compliance management on the recent global developments and trends of significance across the API, OTC, sterile product, compounding, and supply chain arenas.
- [NIIMBL Progress Includes Partnership with Biophorum on Buffer Mixing and Global Health Fund with Gates Foundation](https://ipq.org/niimbl-progress-includes-partnership-with-biophorum-on-buffer-mixing-and-global-health-fund-with-gates-foundation/) - The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is partnering with the industry consortium BioPhorum to develop a more streamlined, cost-effective, and resource-conserving way of addressing the buffers used in biopharmaceutical manufacturing.
- [IPQ Monthly Update – April / May 2020 in Review](https://ipq.org/ipq-monthly-update-april-may-2020-in-review/) - The need for intensive collaboration to address the complex challenges of assuring the quality and availability of the world’s medicines has only deepened in the face of the global pandemic we are now facing, as the two stories in our review of April and May make clear. ● The first story is a five-part exploration of the collaborative efforts now going on globally to advance in vitro testing in assessing and controlling adventitious viruses for vaccines and biotherapeutics – and to unleash the potential of next-gen sequencing in particular. ● The second story explores how the National Institute for Innovation in Manufacturing Biopharmaceuticals has been evolving and some of the challenges now drawing the attention of the public/private partnership.
- [USP Convention Meets Virtually in May 2020 to Review Upcoming Priorities, with Both 200-Year Legacy and Current Pandemic in Focus](https://ipq.org/usp-convention-meets-virtually-in-may-2020-to-review-upcoming-priorities-with-both-200-year-legacy-and-current-pandemic-in-focus/) - In May 2020, the USP Convention (USPC) met virtually to review how its central role in advancing public health has evolved during the broad sweep of its 200-year history on the one hand, while assessing its response to the pressing needs of the COVID-19 crisis now dominating the healthcare field on the other.
- [Synthesis and Analysis Advancements Are Unleashing the Potential of Peptides and Oligos, Spurring CMC Regulatory Dialogue](https://ipq.org/synthesis-and-analysis-advancements-are-unleashing-the-potential-of-peptides-and-oligos-spurring-cmc-regulatory-dialogue/) - Advancements in synthesis and analysis technologies are helping unleash the therapeutic potential of peptides and oligonucleotides, spurring the dialogue on how the CMC/quality regulatory expectations, guidance and standards should keep pace.
- [IPQ Monthly Update – June 2020 in Review](https://ipq.org/ipq-monthly-update-june-2020-in-review/) - In this issue, IPQ explores the dialogue on how the CMC/quality regulatory expectations, guidance and standards can keep pace with and best support the expanding therapeutic potential of peptides and oligonucleotides. The second story focuses on the discussion at USP’s five-year meeting in May by its leadership of the key challenges that the world faces in assuring the supply of quality medicines and the role that USP can play in addressing the challenges through its standards setting, advocacy, and capability building efforts.
- [Design-Based Development Paradigm for Cell/Gene Therapies Will Significantly Reduce Costs, Timelines and Regulatory Concerns, AGT CEO Galvin Maintains](https://ipq.org/design-based-development-paradigm-for-cell-gene-therapies-will-significantly-reduce-costs-timelines-and-regulatory-concerns-agt-ceo-galvin-maintains/) - The more efficient, design-based development paradigm for cell and gene therapies, coupled with their therapeutic power, will dramatically reduce manufacturing and testing costs and timelines and significantly alter the regulatory dynamics, American Gene Technologies CEO Jeff Galvin affirmed in his plenary presentation at the PDA annual meeting held virtually in late July.
- [Stronger Unapproved Stem-Cell Enforcement Accompanies FDA Center for Biologics’ Cell and Gene Therapy Advancement Efforts](https://ipq.org/stronger-unapproved-stem-cell-enforcement-accompanies-fda-center-for-biologics-cell-and-gene-therapy-advancement-efforts/) - Over the last few years, FDA has ramped up its efforts to protect the public from unapproved and potentially dangerous stem cell products, while striving to create a regulatory framework and approach that is as supportive as possible for the advancement of the entire cell and gene therapy (CGT) field.
- [IPQ Monthly Update – July/August 2020 in Review](https://ipq.org/ipq-monthly-update-july-august-2020-in-review/) - The first story provides thought-provoking insights from Jeff Galvin, the CEO of California-based American Gene Technologies (AGT), on the implications of the design-based development paradigm and therapeutic power that comes into play for cell and gene therapies. The multipart story that follows takes our readers inside FDA’s efforts to adapt its CMC regulatory processes and expectations to the CGT needs. Addressed are the various ways in which CBER has been seeking to fulfill the two complementary sides of FDA’s mission in the CGT arena – protecting the public from unapproved and potentially dangerous products, and striving to create a regulatory framework and approach that is as supportive as possible for advancing the field.
- [CBER Director Marks Traverses the Complex COVID-19 Vaccine/Therapy Regulatory Landscape at FDLI’s Annual Conference](https://ipq.org/cber-director-marks-traverses-the-complex-covid-19-vaccine-therapy-regulatory-landscape-at-fdlis-annual-conference/) - At the 2020 annual conference of the Washington, D.C.-based Food and Drug Law Institute (FDLI), held virtually on October 6-8, Center for Biologics Evaluation and Research (CBER) Director Peter Marks provided valuable insights on the difficult terrain that the regulators at CBER have to navigate to reach their goal of making effective vaccines and therapeutics for COVID-19 available as efficiently as possible.
- [USP’s Global Efforts to Strengthen Standards and Accelerate Innovation for Biologics Include ICH Engagement](https://ipq.org/usps-global-efforts-to-strengthen-standards-and-accelerate-innovation-for-biologics-include-ich-engagement/) - Direct engagement in the ICH guideline development and revision process is helping USP prioritize its related compendial standard setting, revision, and harmonization efforts, and, in turn, enriching ICH awareness of the pharmacopeial standards and approaches that can help inform its guidelines.
- [Pandemic Stresses Increase FDA Attention on Risk Management Plans for Drug Shortage Prevention and Mitigation](https://ipq.org/pandemic-stresses-increase-fda-attention-on-risk-management-plans-for-drug-shortage-prevention-and-mitigation/) - The stresses of the COVID pandemic on the drug supply chain have thrown a spotlight on the importance of risk management plans (RMPs) in preventing and addressing drug shortages.
- [IPQ Monthly Update – September/October 2020 in Review](https://ipq.org/ipq-monthly-update-september-october-2020-in-review/) - The impact of the COVID-19 pandemic remained central to IPQ’s coverage during September and October. The three stories in this issue focus on: ● the insights from CBER Director Peter Marks on the difficult terrain that regulators have to navigate with industry to reach the goal of getting effective vaccines and therapies for COVID-19 available as efficiently as possible ● USP’s global collaborative efforts to strengthen the standards and accelerate innovation in the biologics arena, and ● the attention FDA is putting on risk management plans (RMPs) to help in the drug shortage prevention and mitigation part of the pandemic response.
- [COVID Vaccine Global Distribution Challenges Explored by Bio Supply Management Alliance (BSMA) Panel of European Experts](https://ipq.org/covid-vaccine-global-distribution-challenges-explored-by-bio-supply-management-alliance-bsma-panel-of-european-experts/) - A panel of leading experts, assembled virtually for the 2020 Bio Supply Management Alliance (BSMA) Europe symposium on November 12, seized on the analogy of a Formula One race pitstop in assessing the expertise, cooperation, and timing that will be needed for successfully delivering COVID-19 vaccinations.
- [IPQ Monthly Update – November/December 2020 in Review](https://ipq.org/ipq-monthly-update-november-december-2020-in-review/) - IPQ’s attention during November and December remained centered on the impact of the COVID-19 pandemic. In focus in the two stories in the issue are: ● insights from European experts on the myriad of complex issues that have to be addressed in getting the vaccines from manufacturers into the arms of the billions of people around the world that will need to receive them, and ● how the internal operations and external communication processes among pharmacopeias, industry and regulators are being adapted and collaboration expanded.
- [Pandemic Intensifies USP's Focus on Supply Chain Vulnerabilities and Vaccine Development](https://ipq.org/pandemic-intensifies-usps-focus-on-supply-chain-vulnerabilities-and-vaccine-development/) - Improving understanding of supply chain vulnerabilities and providing support for vaccine development and delivery are two focal points of the USP effort to help address the pressing challenges that the COVID-19 pandemic has brought to the fore regarding the availability of quality medicines.
- [Recent Technology and Partnership Advances Made Possible Precision and Speed of Vaccine Response to Pandemic, NIAID’s Graham Stresses at CASSS WCBP Conference](https://ipq.org/recent-technology-and-partnership-advances-made-possible-precision-and-speed-of-vaccine-response-to-pandemic-niaids-graham-stresses-at-casss-wcbp-conference/) - The precision and speed of COVID-19 vaccine development was made possible by recent R&D advancements and a strengthened network of public-private partnerships, NIH National Institute for Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VCR) Deputy Director Barney Graham affirmed in his keynote presentation at the opening session of the CASSS Well-Characterized Biotechnology Products (WCBP) conference in late January.
- [IPQ Monthly Update – January 2021 in Review](https://ipq.org/ipq-monthly-update-january-2021-in-review/) - Drawing attention in the January issue are: ● how the research, technologies and partnerships that have been gelling in recent years made possible the rapid development of a coronavirus vaccine in 2020 ● how USP has intensified its focus on supply chain vulnerabilities and vaccine/treatment development to help support the pandemic response, and ● FDA’s ongoing progress in improving the usefulness and user-friendliness of its inactive ingredient database (IID).
- [IPQ Monthly Update – February 2021 in Review](https://ipq.org/ipq-monthly-update-february-2021-in-review/) - The issue focuses on how academia and industry are collaborating to address the pressing needs in biopharma workforce development, in recognition of the challenges of keeping pace with the rapidly evolving process and product technologies and the cross-functional understanding and skills needed to support them. The six-part coverage explores the dimensions of these challenges and the collaborations that are being formed and strengthened to address them.
- [IPQ Monthly Update – March 2021 in Review](https://ipq.org/ipq-monthly-update-march-2021-in-review/) - The March issue provides a wealth of insights shared by FDA, EMA and PMDA biotherapeutic and vaccine regulators on the challenges, opportunities, and learnings as they have sought to support the accelerated product development and review called for by the pandemic, while assuring that CMC/quality standards are met and keeping up with their non-COVID-related workload. Included are updates on the guidances and other quality-related initiatives impacting vaccines and biotherapeutics that have been forthcoming during the first quarter of 2021.
- [IPQ’s 2010-2021 Stories on PAC/QRM/KM Regulatory Dialogue](https://ipq.org/ipqs-2010-2021-stories-on-pac-qrm-km-regulatory-dialogue/) - The following is a chronological listing of IPQ stories since 2010 that have covered the pressing issues around post-approval changes and what is needed in conjunction with advancements in risk and knowledge management to make quality regulatory processes across the product lifecycle more cohesive, efficient, process improvement and supply friendly, and internationally harmonized. 2010 ●
- [IPQ Monthly Update – April 2021 in Review](https://ipq.org/ipq-monthly-update-april-2021-in-review/) - The feature story in the April issue explores how regulators and industry are working together to make quality risk management (QRM) a more effective force in improving quality systems and the regulatory communication process at the review and inspections levels. The three parts of the story provide insights from: ● HPRA’S Kevin O’Donnell on the evolution of QRM and the revision now underway of ICH’s 15-year-old QRM guideline Q9, which he is leading ● FDA’s Rick Friedman, also on the Q9 revision Expert Working Group, on advancing aseptic processes through QRM, and ● industry/academia thought leaders on evolving QRM’s relationship with knowledge management across the product lifecycle.
- [IPQ Monthly Update – May 2021 in Review](https://ipq.org/ipq-monthly-update-may-2021-in-review/) - The pressing need during the COVID-19 pandemic to accelerate product development and rapidly accommodate the shifting manufacturing and distribution demands has shed strong light on the constraints in the existing quality regulatory framework and the pathways to reducing them. The two-part feature story in this issue explores how the ICH Q8-12 efforts to evolve the lifecycle regulatory paradigm to be more transparent, internally coherent, knowledge and risk based, continuous improvement and supply friendly, and globally consistent have not yet been realized, and where the deeper solutions to the problems may lie.
- [IPQ Monthly Update – June 2021 in Review](https://ipq.org/ipq-monthly-update-june-2021-in-review/) - The four-part IPQ story in this issue explores the current dialogue on the drivers and pathways for a more collaborative, streamlined and globally-minded regulatory approach to medicine/device combination products in Europe and the activity in progress to reach that goal. In focus in the four parts are: ● the EU Pharma Strategy roadmap, comments from industry, and related agency strategies ● culture/structure/process change and global alignment ● HPRA CEO Lorraine Nolan on HPRA and EMA strategy, and ● EMA’s Zaïde Frias and NB/industry perspectives on EU regulatory transformation.
- [IPQ Monthly Update – July 2021 in Review](https://ipq.org/ipq-monthly-update-july-2021-in-review/) - The feature story in this issue explores the dialogue regulators and industry are having on the key CMC issues that are presenting themselves in the development and review of peptides and oligonucleotides and the approaches and expectations for addressing them. A central focus is the discussion that took place at the USP 2021 peptides/oligonucleotides workshop. The story’s four parts explore: ● recent CMC/regulatory challenges of oligonucleotide drugs ● comparability challenges in crossing over to generics, including insights from recent FDA research ● comparing peptide and oligonucleotide CMC issues, and ● starting material specifications for oligonucleotides.
- [IPQ Monthly Update – August 2021 in Review](https://ipq.org/ipq-monthly-update-august-2021-in-review/) - The feature story in this issue centers on the challenges and developments around raw material control for biological products. A main focus is the discussion that took place at a USP workshop on the raw material issues held in April 2021. The story’s three parts delve into: ● FDA views on where the regulatory concerns and expectations lie across the review and inspection continuum ● how the challenges expand in handling raw materials in the CGT context, and ● where biomanufacturers are in using and controlling polysorbates, in particular.
- [IPQ Monthly Update – September/October/November 2021 in Review](https://ipq.org/ipq-monthly-update-september-october-november-2021-in-review/) - The multipart feature story in this issue focuses on the insights that the leaders of five of the major COVID vaccine efforts have been sharing at recent conferences on: ● how the daunting development, manufacturing, supply chain and regulatory challenges involved in delivering a vaccine at the global level in unprecedented speed during a pandemic were addressed, and ● the lessons that can be garnered from that highly collaborative experience in moving forward.
- [IPQ Monthly Update – December 2021 in Review](https://ipq.org/ipq-monthly-update-december-2021-in-review/) - The two stories in IPQ’s December Monthly Update explore: ● the recent efforts of the USP and European Pharmacopeia to meet the needs of the emerging biotech product modalities and their complex analytical challenges, and ● recent developments in the European GMP arena as its regulator and industry stakeholders work with their counterparts globally to digest and deploy the experience and learnings from the pandemic.
- [IPQ Monthly Update – January and February 2022 in Review](https://ipq.org/ipq-monthly-update-january-and-february-2022-in-review/) - The two stories in IPQ’s January/February issue explore: ● FDA, industry consortium, and ICH efforts to modernize the way quality information is collected, submitted, and managed, and ● the efforts to strengthen the interface between FDA and industry around manufacturing modernization, with insights from two innovation champions, Janet Woodcock and Jeff Baker.
- [IPQ Monthly Update – March and April 2022 in Review](https://ipq.org/ipq-monthly-update-march-and-april-2022-in-review/) - The two stories in IPQ’s March/April 2022 issue explore: ● the drivers for and progress in incorporating more third-party auditing of excipient suppliers into user quality management systems, and ● updates from regulator, compendial and industry experts on the CMC challenges of peptides and oligonucleotides.
- [IPQ Monthly Update – May 2022 in Review](https://ipq.org/ipq-monthly-update-may-2022-in-review/) - The three-part story featured in IPQ’s May Monthly Update explores how the pandemic and longer-term trends are converging to spur pharma innovation, collaboration, and operations modernization. In focus in the three parts are: ● insights on these trends from key thought leaders ● the coordination role the US government is playing in addressing the pandemic and other health crises, and ● how the Gates Foundation is helping support the development of new technologies for improving vaccine access in low- and middle-income countries (LMICs).
- [IPQ Monthly Update – June/July 2022 in Review](https://ipq.org/ipq-monthly-update-june-july-in-review/) - The four-part story featured in IPQ’s June/July Monthly Update explores how an FDA-commissioned study carried out though the National Academies of Sciences, Engineering, and Medicine (NASEM) is helping drive the industry/regulator dialogue and agenda on advancing innovation in pharmaceutical manufacturing. With a workshop held on the study report as a central point of reference, the four parts cover: ● the study’s focus, aim, process, organizations involved, and recommendations ● the mechanisms that are now in place to enable innovation ● the challenges and opportunities that are presenting themselves, and ● the path forward. Included are updates on related developments and discussions since the workshop was held.
- [IPQ Monthly Update – August/September 2022 in Review](https://ipq.org/ipq-monthly-update-august-september-2022-in-review/) - The two stories featured in IPQ’s August/September 2022 issue explore: ● the dialogue now going on among regulators, pharmacopeias, and industry on the challenges associated with the manufacturing, characterization, and QC of nanoparticle-based formulations, and ● how CBER’S Advanced Technologies Program (ATP) is being strengthened through the expansion of internal and external funding, scientific and regulatory expertise, and CBER Advanced Technologies Team (CATT) collaboration, and the recent experience of CDER’s Emerging Technology Team (ETT).
- [IPQ Monthly Update – October 2022 in Review](https://ipq.org/ipq-monthly-update-october-2022-in-review/) - The story featured in IPQ’s October 2022 issue focuses on how EMA’s toolbox on CMC flexibilities has been evolving to incorporate industry input and learnings from the pandemic. The three parts of the story center around the discussions that took place at a session of the October 2022 CASSS CMC Strategy Forum at which regulator and industry leaders shared their experiences and learnings in applying flexibility tools from a regional and global perspective.
- [IPQ Monthly Update – November 2022 in Review](https://ipq.org/ipq-monthly-update-november-2022-in-review/) - The experience of the pandemic has underscored the criticality of assuring that regulatory processes keep pace with innovation in the manufacturing and control arena and has spurred the efforts that were underway in Europe to assess the issues involved and implement the adaptations needed to address them. The three parts of the IPQ story featured in IPQ’s October 2022 issue address the progress of these efforts.
- [IPQ Monthly Update – December 2022 in Review](https://ipq.org/ipq-monthly-update-december-2022-in-review/) - The story featured in IPQ’s December 2022 issue focuses on the issues that have arisen and the progress that has been made in implementing the risk-based assessment strategy for elemental impurities (EIs) provided in ICH Q3D. The four parts of the story address: ● the role of a watershed workshop cosponsored by the Product Quality Research Institute (PQRI) and FDA ● the perspectives and experience of US and European regulators ● USP and Ph. Eur. harmonization with ICH Q3D, and ● the outcomes of a PQRI study on variability in EI analysis.
- [CDER’s Office of Pharmaceutical Quality is Opening New Regulatory Pathways to Span Its Broad Responsibilities and Global Reach](https://ipq.org/cders-office-of-pharmaceutical-quality-is-opening-new-regulatory-pathways-to-span-its-broad-responsibilities-and-global-reach/) - The “strategic priorities” of the Office of Pharmaceutical Quality (OPQ) for the next few years speak to the wide breadth and global reach of its regulatory responsibilities, and to OPQ’s willingness to open new pathways to fulfill them.
- [Role of Established Conditions Drawing Attention in Global Dialogue on ICH Q12’S Potential](https://ipq.org/role-of-established-conditions-drawing-attention-in-global-dialogue-on-ich-q12s-potential/) - The interpretation and application of the approaches for determining established conditions (ECs) provided in the Step 2 draft of ICH Q12 and how these interface with regulatory reporting expectations is drawing particular attention as industry explores the opportunities that the ICH Q12 concepts present in practice.
- [IPQ Monthly Update – May/June 2018 in Review](https://ipq.org/ipq-monthly-update-may-june-2018-in-review/) - The issue includes in-depth stories on: ● the intensive dialogue going on now in the wake of the emergence of an ICH Q12 Step 2b draft for public comment ● the role EFPIA’s European Biopharma Enterprises (EBE) is playing in identifying and building consensus around the most pressing issues on the global regulatory agenda for biotech manufacturing and control, and ● the experience at a leading in vitro fertilization (IVF) clinic in figuring out the cause of dramatic periodic declines in the clinic’s normal best-in-class success rates and what needed to be done to prevent them, including the development of much more powerful air purification technology.
- [IPQ Monthly Update -- July 2014 in Review](https://ipq.org/ipq-monthly-update-july-2014/) - The July Monthly Update reviews the progress of the initiative’s “roadmap” on its various fronts. The initial gap analyses have produced some surprising findings of divergences in country supply chain regulatory policies – the US allowance for repackaging and internet sales, and the lack of connection elsewhere between customs offices and health agencies, among them.
- [IPQ Monthly Update -- August/September 2014 in Review](https://ipq.org/ipq-monthly-update-aug-sept-2014/) - Prominent among the CMC/GMP developments in September was a well-thought out proposal from a team of prominent industry experts on how to alter the current CMC submission process to encourage transparency and continuous improvement and to incentivize and reward the advancement of QbD. The proposal has high relevance to ICH’s nascent Q12 initiative on life-cycle management.
- [IPQ Monthly Update -- October 2014 in Review](https://ipq.org/ipq-monthly-update-october-2014/) - In focus are: ● the structure/function changes FDA is making to help drive a new pharmaceutical quality regulatory paradigm with closer center/field alignment ● the role that the new Office of Pharmaceutical Quality will play in steering the various significant initiatives that are now in motion, and ● the implementation challenges presented by the new ICH guidelines on elemental impurities (ICH Q3D) and mutagenic impurities (ICH M7), respectively.
- [IPQ Monthly Update -- November 2014 in Review](https://ipq.org/ipq-monthly-update-november-2014/) - The Monthly Update for November delves deeper into the infrastructure of CDER’s new Office of Pharmaceutical Quality. In focus are two of OPQ’s offices that will be on the front line of the industry/agency interactions: ● the Office of Program and Regulatory Operations (OPRO), which will play a pivotal role in CMC reviews for both NDAs and ANDAs, and ● the Office of Surveillance, which will be spearheading the agency’s effort to more coherently assess a company’s quality management abilities and retool its inspection operations accordingly.
- [IPQ Monthly Update, December 2014](https://ipq.org/ipq-monthly-update-december-2014-2/) - Headlining IPQ’s international coverage in December is the ICH Q12 effort to identify the constraints in the current quality regulatory paradigm to innovation and continual improvement across the product lifecycle and how it can be adjusted to remove them. Also in focus in the December issue are the structural and functional changes FDA is making to its center and field operations to address these constraints....
- [IPQ Monthly Update, January/February 2015](https://ipq.org/ipq-monthly-update-januaryfebruary-2015-2/) - During January and February, IPQ explored several impactful initiatives that are underway in different areas of the pharmaceutical manufacturing and control arena to create standards and databases that will make both industry and regulators more effective and allow them to communicate better. These include the efforts of: ● the industry-driven Allotrope Foundation to create lab data standards and the “lab of the future”● FDA in cooperation with industry to continue to implement the 2013 Drug Supply Chain Security Act ● regulators, industry and academia to upgrade pharmaceutical excipient databases, and ● Asian regulators, in line with those in the US and Europe, to address a new generation of regulatory challenges....
- [IPQ Monthly Update, March 2015](https://ipq.org/ipq-monthly-update-march-2015-2/) - During March, IPQ focused on the dialogue that has been intensifying at public forums on the daunting manufacturing and control challenges regulators and industry face in guiding the expanding array of cell and gene therapy (CGT) products now under development to commercialization. The five stories in the Monthly Update for March explore the CMC issues the new therapies pose from the European, US and Asian perspectives and where the emerging approaches are converging and diverging. Two of the stories delve further into the especially challenging but critical task of developing potency assays for the advanced therapies, and another spotlights Novartis’ advancing efforts to adapt biotech manufacturing and control technology and systems to make CGT commercialization a reality.
- [IPQ Monthly Update, April/May 2015](https://ipq.org/ipq-monthly-update-aprilmay-2015-2/) - IPQ’s coverage during April and May was heavily focused on how the GMP/quality system thought processes in the pharmaceutical regulatory arena are advancing, and the April and May issues have been combined to bring the stories under one roof. Included in the April/May Monthly Update are stories covering: ● CDER Director Woodcock on the philosophy behind FDA’s “quality revolution” – why fear is antithetical to its goals and why measurement is key ● a Deming Institute expert on where pharma is in applying Deming’s quality philosophy ● a compliance official on what FDA’s foreign inspection findings indicate about pharma’s current risk modeling overseas ● the impact of the new risk-oriented ANSI NSF-IPEC 363 excipient GMP standard on excipient suppliers and drug manufacturers, and ● Sanofi’s effort to coordinate the lifecycle management of its automation systems to head off manufacturing breakdowns.
- [IPQ Monthly Update, July/August 2015 in Review](https://ipq.org/ipq-monthly-update-julyaugust-2015-2/) - Dominating IPQ’s coverage during July and August were the ongoing developments in FDA’s metrics effort and the industry initiatives it is driving. In focus in this issue are: ● FDA’s new draft guidance and where the agency is looking for input from industry, in particular, in refining it, and ● ISPE’s substantial pilot effort to benchmark on current metrics practices and help make the FDA program more viable and meaningful. A third story explores the increasing significance of pharma’s relationship with excipient suppliers from the vantage point of a senior BMS manufacturing executive, and the related IPEC-Americas/IQ Consortium push for a novel excipient regulatory pathway.
- [IPQ Monthly Update, June 2015](https://ipq.org/ipq-monthly-update-june-2015-2/) - In focus are: ● FDA’s CDER on the role of the control strategy in application approval recommendations and the challenges reviewers face in piecing the story together ● the key role a novel excipient played in the development of a new insulin inhalation product and the broader implications of the experience, and ● ICH’s effort to address the pressing questions on API CMC and GMP through Q&As on Q7 and Q11.
- [IPQ Monthly Update - September 2015 in Review](https://ipq.org/ipq-monthly-update-september-2015-in-review/) - In focus in IPQ’s coverage during September: ● FDA’s “New Inspection Protocol Pilot” (NIPP), which has significant implications for pre-approval, surveillance, and for-cause inspections going forward ● the thoughts, concerns and suggestions that emerged at the meeting the agency held in late August to solicit feedback on its quality metrics draft guidance ● biomanufacturing site transfers and the role stress studies are playing at Roche/Genentech in assuring comparability, and ● the challenges in the analytical methods handoff component of the site transfer process.
- [IPQ Monthly Update - October 2015 in Review](https://ipq.org/ipq-monthly-update-october-2015-in-review/) - The coming into force of a significant revision of EU GMP Annex 15 in early October, and its insertion into the PIC/S GMPs, has created heightened attention on the evolving global process validation expectations at recent public forums. The October Monthly Update explores: ● the changes made in the revision and their impact ● how the annex now compares with FDA’s process validation guidance, and ● what regulators around the world are now expecting and the problems they are finding during inspections in reviewing industry’s PV performance.
- [IPQ Special Report -- September/October 2007 in Review](https://ipq.org/septemberoctober-2007/) - APPLYING QUALITY BY DESIGN TO BIOPHARMACEUTICALS is testing the viability of the definitions that have been jelling in the small-molecule context. Establishing the linkage between quality attributes and clinical performance – a foundation block for the quality-by-design structure – is a particular challenge in the biotech arena, and pathways for tightening this linkage are being explored and discussed.
- [IPQ Special Report -- January/February 2009 in Review](https://ipq.org/januaryfebruary-2009/) - THE REGULATORY STANDARDS FOR ASEPTIC PROCESSING ARE UNDER SCRUTINY as industry moves to interpret and implement the 2008 revisions to Annex 1 of the EU GMPs. At recent public forums, the dialogue on the implications of the Annex 1 revisions has brought to the surface deeper questions about the foundation on which aseptic processing standards have rested.
- [IPQ Special Report -- March/April 2009 in Review](https://ipq.org/march-april-2009/) - DRUG MANUFACTURERS ARE REASSESSING HOW THEY MANAGE REGULATORY INSPECTIONS as they shift focus onto the challenge of conveying the strength of their quality systems to find and address problems and risks.
- [IPQ Special Report -- May/June 2009 in Review](https://ipq.org/may-june-2009/) - ANALYSIS OF FDA AND EU GMP ENFORCEMENT ACTIVITY shows inadequate investigation of manufacturing and product nonconformances to be the most pressing concern on both sides of the Atlantic.
- [IPQ Special Report -- May 2010 in Review](https://ipq.org/ipq-may-2010/) - THE QUALITY REGULATORY INITIATIVES UNDERWAY AS THE NEW DECADE BEGINS show the strong imprint of ICH Q8-10 at both the agency and international levels. From CMC application review to GMP inspections, from development to post-market manufacturing, from the ingredient supply chain through product distribution, the quality-by-design, risk management and quality system principles built into the new ICH guidelines are being integrated into industry/regulator interactions and the guidance, policies and initiatives that define them.
- [IPQ Monthly Update -- July 2010 in Review](https://ipq.org/ipq-monthly-update-july-2010/) - The inaugural issue of IPQ’s “Monthly Update” on key CMC/GMP developments in the US, Europe, and internationally. The IPQ family of publications has been expanded this Spring to include breaking stories “In the News” on our web site, “Weekly News Alerts” sent via e-mail, and the “Monthly Update.” These now accompany our uniquely valuable in-depth “Special Reports” on emerging areas of concern drawing particular attention from industry and regulators.
- [IPQ Monthly Update -- August 2010 in Review](https://ipq.org/ipq-monthly-update-august-2010/) - Included in the US coverage in IPQ’s just-released “Monthly Update — August 2010” is advice from FDA biotechnology regulators on how to communicate with the agency to avoid CMC stumbling blocks and smooth the development, IND and marketing application clearance process for new biotech products. On the inspection side, in focus are: ● Congressional efforts to upgrade FDA’s recall and supply chain authorities ● the latest on McNeil’s compliance issues and the impact on J&J finances ● the new inspection initiative by CDER putting Part 11 back in the limelight, and ● a warning letter to Sanofi that shows FDA’s ongoing concern with vaccine manufacturing.
- [IPQ Monthly Update -- September 2010 in Review](https://ipq.org/ipq-monthly-update-september-2010/) - How regulators will be evaluating and enforcing quality risk management (QRM) received particular attention across the global regulatory landscape this past month. UK’s medicines agency and WHO both released guidance addressing QRM inspection expectations – the former in the form of an FAQ, the latter as a draft guideline for comment. The September IPQ Monthly Update also includes a discussion by FDA’s drug compliance office of the pivotal role of supplier/manufacturer communication in managing supply chain risks.
- [IPQ Monthly Update -- October 2010 in Review](https://ipq.org/ipq-monthly-update-october-2010-2/) - Dominating IPQ’s coverage during October were GMP compliance problems at both U.S. and foreign manufacturing facilities and the insight they provide on where FDA’s concerns lie and how it will respond when product quality is jeopardized.
- [IPQ Monthly Update -- November 2010 in Review](https://ipq.org/ipq-monthly-update-november-2010/) - Among the important regulatory developments in the U.S. in November was a hearing held by FDA to obtain input on specific issues and challenges associated with the implementation of the new biosimilars legislation. IPQ’s coverage encompasses a proposal from Amgen at the hearing on a two-tier process in which interchangeability decisions would trail biosimilar approvals.
- [IPQ Monthly Update -- December 2010 in Review](https://ipq.org/ipq-monthly-update-december-2010/) - The IPQ Monthly Update for December focuses heavily on the the ongoing efforts around the world to build a more harmonized foundation for regulating drug and biologic quality.
- [IPQ Monthly Update -- January 2011 in Review](https://ipq.org/ipq-monthly-update-january-2011/) - In focus in IPQ’s international coverage for January are the latest developments in the effort by the ICH Q11 Expert Working Group to craft a viable drug substance guideline, which is nearing the Step 2 publication finish line.
- [IPQ Monthly Update -- February 2011 in Review](https://ipq.org/ipq-monthly-update-february-2011/) - IPQ’s coverage of CMC and GMP developmentms in the Asia Pacific region continues in the February Monthly Update with an analysis of South Korea’s quest to harmonize and keep pace with the advancing international pharmaceutical quality regulatory paradigm.
- [IPQ Monthly Update -- March 2011 in Review](https://ipq.org/ipq-monthly-update-march-2011/) - IPQ’s coverage of the developments during March provides a wealth of insights into the quality regulatory challenges posed by products outside the typical pharmaceutical profile – high technology products with complex delivery systems on the one side, and products which elevate standard excipients into the active drug category and/or do not meet the approved drug criteria on the other.
- [IPQ Monthly Update -- April 2011 in Review](https://ipq.org/ipq-monthly-update-april-2011/) - The GMP regulatory umbrella is expanding around the globe to encompass a more defined body of good distribution practices (GDPs) and increased enforcement of supply chain controls. The Monthly Update for April includes six stories on key developments in the industry/regulator effort to better control the global supply chain.
- [IPQ Monthly Update -- May 2011 in Review](https://ipq.org/ipq-monthly-update-may-2011/) - In the forefront of the IPQ coverage for May are important initiatives going on in Europe to improve and harmonize its regulation of medicinal quality and the supply chain on which that quality depends.
- [IPQ Monthly Update -- June 2011 in Review](https://ipq.org/ipq-monthly-update-june-2011/) - The progress that industry and regulators are making in implementing the ICH Q8-10/QbD-based regulatory paradigm and where further work needs to be done is the focus of a series of four stories included in the IPQ June “Monthly Update.”
- [IPQ Monthly Update -- July/August 2011 in Review](https://ipq.org/ipq-monthly-update-julyaugust-2011/) - The complex issues that glass control presents for injectable products were explored at a two-day conference cosponsored by PDA and FDA and a one-day follow-up symposium organized by the supply chain consortium Rx-360 in late May. The Monthly Update includes a series of six stories stemming from the probing presentations and industry/regulator dialogue at the meetings. Taken together, the series provides an in-depth look at this front-burner topic and its significance.
- [IPQ Monthly Update -- September 2011 in Review](https://ipq.org/ipq-monthly-update-september-2011/) - The challenges of regulating a global pharmaceutical supply chain are prompting significant changes in the way FDA is operating and its interconnections to the wider regulatory community. IPQ’s Monthly Update for September explores these changes as the agency strives to match its far-reaching responsibilities with its resource limitations and, in conjunction with other international regulators, create a more efficient and better coordinated oversight approach.
- [IPQ Monthly Update -- October 2011 in Review](https://ipq.org/ipq-monthly-update-october-2011/) - In the October Update, IPQ focuses on the discussion at an October ICH Q10 conference around the dichotomy between the continuous improvement objectives of the new paradigm and the roadblocks presented by the disharmony in change filing requirements across the globe. A second story focuses on the European Commission’s effort to further rationalize and harmonize the handling of variation filings across Europe.
- [IPQ Monthly Update -- November 2011 in Review](https://ipq.org/ipq-monthly-update-november-2011/) - China’s CMC and GMP landscape is changing, providing opportunities for the global pharmaceutical community to help shape the outcome. The Monthly Update for November includes a series of four in-depth stories based on the insights provided by key regulatory experts on China at the AAPS and ISPE annual meetings this fall.
- [IPQ Monthly Update -- January 2012 in Review](https://ipq.org/ipq-monthly-update-january-2012/) - The January Monthly Update begins with an analysis of the impact of generic drug user fees and where the industry and agency dialogue has arrived in crafting a viable agreement on their implementation.
- [IPQ Monthly Update -- February 2012 in Review](https://ipq.org/ipq-monthly-update-february-2012/) - Biosimilars, user fees and drug shortages are three issues dominating the dialogue in the US generic drug regulatory arena, and FDA, Congress, industry and public interest groups are all very much caught up in the complexities of addressing them. The Monthly Update has stories on each of the three issues in turn.
- [IPQ Monthly Update -- March 2012 in Review](https://ipq.org/ipq-monthly-update-march-2012/) - IPQ’s March Monthly Update includes in-depth coverage of several important initiatives underway in the US, Europe and ICH to clarify and harmonize the regulatory expectations for API control across the drug and biotech spectrum.
- [IPQ Monthly Update -- April 2012 in Review](https://ipq.org/ipq-monthly-update-april-2012/) - Regulators are refining their inspection mechanisms for uncovering risks and are looking for industry to do the same internally. Under the new regulatory paradigm, not defining manufacturing risks will be viewed as high-risk behavior. The April Monthly Update includes a close look at key developments in the quality risk management (QRM) arena.
- [IPQ Monthly Update -- May 2012 in Review](https://ipq.org/ipq-monthly-update-may-2012/) - In the May Monthly Update, IPQ focuses on the GMP inspection and enforcement developments at FDA and their global impact, on the one hand, and the efforts at EMA to further refine and harmonize the European CMC expectations for clearing products for marketing, on the other.
- [IPQ Monthly Update -- June 2012 in Review](https://ipq.org/ipq-monthly-update-june-2012/) - Innovator companies have been advancing their QbD programs and these efforts have been finding their way into marketing applications. One of the companies that has been most aggressive and successful in moving down the QbD pathway, as IPQ’s June Monthly Update chronicles, is Vertex – an innovator that uses contractors to do all of its clinical and commercial manufacturing, from bulk production through final packaging.
- [IPQ Monthly Update -- July/August 2012 in Review](https://ipq.org/ipq-monthly-update-julyaugust-2012/) - The release of new EMA and FDA guidances defining their expectations for assuring the quality of biosimilars has heated up the dialogue around the current state of biotech science and regulation. The IPQ Monthly Update takes a deep dive into the key facets of this dialogue and the biosimilar regulatory issues that are on the table.
- [IPQ Monthly Update -- September 2012 in Review](https://ipq.org/ipq-monthly-update-september-2012/) - The September Monthly Update takes a deep dive into FDA’s broad-ranging efforts to create a more efficient and effective generic drug review process, supported by QbD and user fees, that can address an expanded backlog of ANDAs and fulfill its GDUFA commitments to industry.
- [IPQ Monthly Update -- October 2012 in Review](https://ipq.org/ipq-monthly-update-october-2012/) - IPQ’s October Monthly Update takes a hard look at the current state of pharmaceutical manufacturing and regulation – where the problems lie and what the most knowledgeable of the industry and regulator participants in the global dialogue view as the path to move forward.
- [IPQ Monthly Update -- November 2012 in Review](https://ipq.org/ipq-monthly-update-november-2012/) - Due to the critical nature of the compounding crisis and to help facilitate the dialogue around how such tragedies can be prevented in the future, IPQ is making this report publicly available beyond its subscription/licensee base.
- [IPQ Monthly Update -- December 2012 in Review](https://ipq.org/ipq-monthly-update-december-2012/) - The December Monthly Update includes additional coverage of the developments and revelations that have been forthcoming since IPQ released its in-depth special report on the “Current Crisis in Pharmacy Compounding and its Implications” in early November, along with updates on Q3D and FDA inspection of CMOs.
- [IPQ Monthly Update -- September 2013 in Review](https://ipq.org/ipq-monthly-update-september-2013/) - The dialogue has been heating up in the US on the CMC/GMP implications involved in implementing FDASIA’s expedited development and review provisions for breakthrough therapies. The constraints of the current CMC review paradigm are coming into high relief as manufacturing finds itself on the critical path.
- [IPQ Monthly Update -- May 2014 in Review](https://ipq.org/ipq-monthly-update-may-2014/) - The Monthly Update for May begins with an analysis of the excipient DMF-based regulatory process in the US and the discussions that flowed at an IPEC workshop on where the problems lie and what firms can do to address them. Included are insights from a CDER official involved in DMF management.
- [IPQ Monthly Update - January 2016 in Review](https://ipq.org/ipq-monthly-update-january-2016-in-review/) - FDA’s vision of a quality regulatory process that would be more efficient, science-based, review/inspection coherent, and process improvement and product supply friendly took more concrete shape during 2015. The January Monthly Update explores what the progress looks like across CDER’s Offices of Generic Drugs and Pharmaceutical Quality. Also in focus is the complex web of challenges that a global drug distribution system presents in trying to identify and trace products and what regulators and industry are trying to do to deal with it.
- [IPQ Monthly Update - February / March 2016 in Review](https://ipq.org/ipq-monthly-update-february-march-2016-in-review/) - IPQ continues its in-depth exploration of the changes FDA is making to its quality regulatory structure, processes and expectations – their impact and global significance. Focal points include: ● a progress report on OPQ’s first year ● the manufacturing innovation taking place in the more nourishing regulatory environment ● other key issues on the current OPQ agenda ● CDER’s new risk-based API review process, and ● reviewer concerns with biotech product excipients. Also covered on the international front are EDQM’s efforts to drive API regulatory harmonization.
- [IPQ Monthly Update - April / May 2016 in Review](https://ipq.org/ipq-monthly-update-april-may-2016-in-review-2/) - In this Update, IPQ explores the complexities and challenges in both the downstream and upstream dimensions of the pharma supply chain. Downstream the IPQ focus continues on the ongoing FDA/industry efforts to implement a comprehensive track & trace system for RX drugs in the US: ● the first story, from the vantage point of FDA and pharma manufacturers ● and the second from that of the wholesalers and distributors. The issue then moves upstream to focus on: ● the divergent ways in which excipients are regulated by agencies around the world ● and how the biotech industry is cooperating to better control the raw materials needed to process and formulate its products.
- [IPQ Monthly Update - June / July 2016 in Review](https://ipq.org/ipq-monthly-update-june-july-2016-in-review-2/) - In focus are the active discussions now going on between industry and regulators on: ● the role that knowledge management can play in evolving the lifecycle quality regulatory paradigm ● how to make the agency’s inactive ingredient database (IID) as accurate and useful as possible, and ● how regulators are refining their expectations and guidance around data integrity based on their inspection experience, and what companies should be doing, in turn, to uncover, fix, and prevent data integrity problems.
- [IPQ Monthly Update – August / September 2016 in Review](https://ipq.org/ipq-monthly-update-august-september-2016-in-review-2/) - In focus are: ● the concerns biotech product regulators in the U.S. and Europe are raising during their CMC and inspection reviews and the ongoing efforts to facilitate the development and clearance process ● the excipient/material issues that are surfacing in reviewing new drug delivery systems and how FDA’s inactive ingredient database (IID) can help, and ● how the vision of mutual inspection reliance between the U.S. and Europe is taking shape.
- [IPQ Monthly Update – December 2016 in Review](https://ipq.org/ipq-monthly-update-december-2016-in-review-2/) - During December, IPQ explored how the increasing complexity, diversity and importance of drug/biologic/device combination products are driving regulators and industry to seek clearer, more risk-based and more harmonized regulatory processes and expectations. The first story focuses on the situation in Europe, and the second on the industry initiatives underway in the US, Europe and globally to help address the combination product regulatory challenges.
- [IPQ Monthly Update – January 2017 in Review](https://ipq.org/ipq-monthly-update-january-in-review/) - During January, IPQ’s attention turned to the potential that international cooperation offers as regulatory agencies move down the pathway from information sharing to mutual recognition. ● The first story focuses on WHO’s role in regulatory capacity building in the biotherapeutics arena. ● The second story provides more on the other key organizations involved in advancing the medicinal quality regulatory process internationally – how they interrelate, what they are trying to accomplish, and the progress they are making.
- [IPQ Monthly Update – April / May 2017 in Review](https://ipq.org/ipq-monthly-update-april-may-2017-in-review-2/) - The issue opens with an in-depth analysis of the array of significant new developments that have occurred in 2017 in FDA’s push to strengthen its regulatory process for drug/device combination products. The focus than shifts to the experience and learnings of the first two companies to cross the CM approval finish line – Vertex and J&J’s Janssen. Moving to developments abroad, the final story centers around the impact on global excipient and pharma filings and product compliance of new requirements in China for the “bundling” of the excipient approval process with drug dossiers.
- [IPQ Monthly Update – June / July 2017 in Review](https://ipq.org/ipq-monthly-update-june-july-2017-in-review-2/) - The issue opens with a review of the key priorities of the European Pharmacopeia and its ongoing initiatives to address them. Included are the pharmacopeia’s efforts in ICH Q3D implementation and in the biotherapeutics and co-processed excipient arenas. The second story focuses on MS-based multi-attribute methodology (MAM) and the increasing attention it is drawing in the industry/regulator dialogue. The attention reflects the potential MAM has already shown in biomolecule characterization, design and development, and the challenges involved in realizing its full potential in streamlining QC release and supporting advanced/continuous processing.
- [IPQ Monthly Update – February / March 2017 in Review](https://ipq.org/ipq-monthly-update-february-march-in-review/) - The issue begins with a story on FDA’s broad-based effort to strengthen the governance, process and outreach aspects of its handling of combination products. Also in focus is the intensive dialogue that is happening around continuous manufacturing. Addressed in separate stories are: ● FDA insights from its growing CM experience, and ● the challenges of assuring excipient viability for CM.
- [IPQ Monthly Update -- January/February 2013 in Review](https://ipq.org/ipq-monthly-update-jan-feb-2013/) - Generic injectable industry compliance problems and their relationship with drug shortages in the US, along with revisions to the EU GMPs and related policies, are two major thrusts of the coverage in the January/February Monthly Update.
- [IPQ Monthly Update -- March 2013 in Review](https://ipq.org/ipq-monthly-update-march-2013/) - The March Monthly Update is centered on the complex web of issues around drug shortages and their interconnection with the compliance problems at contract manufacturers and large scale pharmacy compounders, which in effect serve as sterile product contract manufacturers for hospitals.
- [IPQ Monthly Update -- April 2013 in Review](https://ipq.org/ipq-monthly-update-april-2013/) - The annual conference of the Food and Drug Law Institute (FDLI), held in downtown Washington in mid-April, again provided an important venue for FDA to deliver a “state of the agency” address on the key legal, legislative and regulatory developments during the previous year and what to expect in the year to come. The Monthly Update for April includes companion stories focusing on the insights that Commissioner Margaret Hamburg and CDER Director Janet Woodcock provided into the heightened priority that drug quality issues are being given in the overall agency agenda.
- [IPQ Monthly Update -- May 2013 in Review](https://ipq.org/ipq-monthly-update-may-2013/) - The role of human factors analysis in the development and approval of combination products has been getting increasing attention from both industry and regulators. The first story in the May Monthly Update explores how better HF understanding is driving the development of new combination product technologies and training devices that have the potential to significantly cut down on user errors and facilitate application clearance. The players featured have some very compelling stories to tell and a lot to teach on realizing the potential that HF analysis offers.
- [IPQ Monthly Update -- June 2013 in Review](https://ipq.org/ipq-monthly-update-june-2013/) - FDA’s center for drugs recognizes that deeper changes to the quality regulatory paradigm are needed to realize the vision embodied in the 21st Century initiative a decade ago of a pharmaceutical industry set on a pathway of continuous process improvement throughout the product lifecycle.
- [IPQ Monthly Update – July/August 2013 in Review](https://ipq.org/ipq-monthly-update-julyaugust-2013-2/) - Included in the July/August Monthly Update is coverage of two significant developments in Europe’s effort to improve its regulation of the globalized supply chain: ● the implementation of the API import provisions of the Falsified Medicines Directive (FMD), and ● the revision of its GMP Annex 16 on QP responsibilities.
- [IPQ Monthly Update -- October 2013 in Review](https://ipq.org/ipq-october-monthly-update-october-2013/) - The Monthly Update for October delves into the issues that the EWG wrestled with in finalizing the Step 2 draft, how the extensive pre-Step 2 vetting process factored in, and the implementation challenges that will need to be faced.
- [IPQ Monthly Update -- November/December 2013 in Review](https://ipq.org/ipq-monthly-update-novemberdecember-2013/) - In the November/December Monthly Update, IPQ focuses on the key learnings from the conference – delving, in particular, into a “state of the union” address delivered at its close by OGD’s acting director Cook Uhl, who reviewed her office’s accomplishments to date, the challenges and priorities it has before it in the coming year, and the intimate role that industry has to play to make the GDUFA vision a reality. The story sheds light on the magnitude and the multifaceted nature of the task underway.
- [IPQ Monthly Update -- January 2014 in Review](https://ipq.org/ipq-monthly-update-january-2014/) - The effort by industry and regulators to develop a better understanding of the connection between product quality and what actually happens in the patient remains on the IPQ front burner, as the Monthly Update for January continues to explore how the effort is playing out in the complex world of biotech product immunogenicity.
- [IPQ Monthly Update -- March/April 2014 in Review](https://ipq.org/ipq-monthly-update-marchapril/) - Funneling from what investigators uncover on the shop floors through FDA’s compliance management to company executives, the concerns addressed in the warning letters indicate where the greatest risks to product quality lie across the industry and where the agency will, in turn, be placing its attention to try and get them addressed. In one sense, warning letters reflect FDA enforcement priorities – in another, they drive them.
- [IPQ Monthly Update -- February 2014 in Review](https://ipq.org/ipq-monthly-update-february-2014/) - IPQ’s Monthly Update for February is centered on how the limitations, constraints, and disconnects in the current CMC regulatory processes around the world are impacting industry’s ability to make manufacturing and control improvements and assure the supply of medicines to the patients who need them.
- [IPQ Monthly Update -- June 2014 in Review](https://ipq.org/ipq-monthly-update-june-2014/) - Central to the IPQ coverage is an explanation of the development, intent and methodology of the new risk-based approach – and the GDUFA and QbD forces that propelled it – by the OGD official leading the initiative. His analysis is key in understanding the significant impact it will have in streamlining the ANDA review process. The new drug staff was engaged in developing the risk principles and algorithms involved, and they will be incorporated into the CMC review process for innovator products as well.
- [IPQ Monthly Update -- November/December 2015 in Review](https://ipq.org/ipq-monthly-update-novemberdecember-2015-in-review/) - With ICH Q12 in process, industry and regulators around the world are taking a hard look at: ● the current post-approval change regulatory quagmire ● what a more efficient, scientifically-based, review/inspection coherent, and process improvement and product supply friendly lifecycle management paradigm would look like, and ● how the international community could harmonize and share resources around it. IPQ departs from the usual Monthly Update format to provide a series of stories exploring the various dimensions of the product lifecycle regulatory challenge and the international effort to better address it.
- [IPQ Monthly Update -- September 2010 Preview Sample](https://ipq.org/ipq-monthly-update-september-2010-preview-sample/) - Preview Sample Copy of IPQ “Monthly Update — September 2010″ As a non-subscriber, we are offering you a preview sample of the IPQ Monthly Update — September 2010, comprised of the first three pages of the actual issue. You will notice on the first page in the table of contents the stories you are missing
- [The Most-Read IPQ Stories of 2013](https://ipq.org/ipqs-most-read-stories-of-2013-2/) - As a retrospective on the past year, IPQ is providing a compilation of the four stories that generated the largest readership. [Available in full to non-subscribers as well as subscribers.] The attention the stories drew is not surprising as they delve into four key current focal points in the CMC/GMP regulatory arena: ● data integrity ● contract relationships ● quality metrics, and ● process validation.
- [The Most-Read IPQ Stories of 2013](https://ipq.org/ipqs-most-read-stories-of-2013/) - As a retrospective on the past year, IPQ is providing a compilation of the four stories that generated the largest readership. [Available in full to non-subscribers as well as subscribers.]
- [IPQ April 2011 Monthly Update Download for IPAC-RS](https://ipq.org/ipac-rs/) - IPQ is pleased to provide the IPAC-RS community with a complimentary download of our April 2011 Monthly Update, covering the important CMC and GMP developments during the Month of April. The issue includes two stories that we think you will find of particular interest stemming from presentations and discussion at the IPAC-RS Conference in April:
- [IPQ April 2011 Monthly Update Download for Jerry's Linkedin Colleagues and Facebook Friends](https://ipq.org/ipq-april-2011-monthly-update-download-for-jerry-chapmans-linkedin-colleagues/) - I am pleased to provide my Linkedin colleagues with a complimentary download of our April 2011 Monthly Update, covering the important CMC and GMP developments during the Month of April. This will allow those of you who do not have a subscription or company license to see the value of our coverage. As a subscriber or company license holder, you would receive this level of in-depth analysis on all of our stories....
- [ISPE Member Download: A Special Report on the Crisis in Pharmacy Compounding and its Implications](https://ipq.org/ispe-member-download-a-special-report-on-the-crisis-in-pharmacy-compounding-and-its-implications/) - By special arrangement with IPQ, ISPE is providing its members a special report on the causes of the health crisis that has unfolded from fungal contamination in pharmacy-compounded injectables and the far-reaching implications that extend across the U.S. drug regulatory arena. Due to the critical nature of the compounding crisis and to help facilitate the
- [PDA Member Download: A Special Report on the Crisis in Pharmacy Compounding and its Implications](https://ipq.org/pda-member-download-a-special-report-on-the-crisis-in-pharmacy-compounding-and-its-implications/) - By special arrangement with IPQ, PDA is providing its members a special report on the causes of the health crisis that has unfolded from fungal contamination in pharmacy-compounded injectables and the far-reaching implications that extend across the U.S. drug regulatory arena. Due to the critical nature of the compounding crisis and to help facilitate the
- [PDA Member Download -- IPQ's Special Report on Pharmacy Compounding](https://ipq.org/pda-member-download-ipqs-special-report-on-pharmacy-compounding/)
- [ISPE Member Download -- IPQ's Special Report on Pharmacy Compounding](https://ipq.org/ispe-member-download-ipqs-special-report-on-pharmacy-compounding/)
- [](https://ipq.org/3662/) - Types of Drug/Device Combination Products in the EU Definition and Example EU Class Regulatory Approval Route Notified Body? Notes Type I Device intended to administer a drug; e.g. a syringe marketed alone intended to be used to administer a drug Device Declaration of conformity by the manufacturer and attachment of CE symbol to the product
- [](https://ipq.org/9589/) - In mid-May, EDQM published a draft of its first finished product monograph, covering sitagliptin phosphate tablets, for comment. The monograph is available in the online forum Pharmeuropa. EDQM notes that “finished product monographs will be elaborated according to the same general principles as for other monographs in the Ph. Eur. to ensure the same high
- [FDA Concern with Particle Contamination and Related Investigations Resurfaces in Warning Letter to Sterile Drug Contract Manufacturer](https://ipq.org/fda-concern-with-particle-contamination-and-related-investigations-resurfaces-in-warning-letter-to-sterile-drug-contract-manufacturer/) - A mid-August warning letter addressing March inspection findings at contract drug manufacturer Hyaluron highlights FDA’s ongoing concerns with particulate contamination problems and their investigation in aseptic manufacturing. The warning letter was issued to the CEO of New York-based Albany Molecular Research, Inc. (AMRI) which purchased ten-year-old Hyaluron in June after the inspection....
- [FDA and EMA Will Launch Collaborative QbD Application Review Pilot](https://ipq.org/fda-and-ema-will-launch-collaborative-qbd-application-review-pilot/) - FDA and EMA will be conducting a pilot program for joint review of the quality-by-design component of new drug marketing applications – bringing the once-distant vision of a common review process a significant step closer to reality....
- [Differences in National Shipping Requirements Challenge International Pharma](https://ipq.org/differences-in-national-shipping-requirements-challenge-international-pharma/) - Pharmaceutical companies are wrestling with how to address the differences in country-specific regulatory requirements for shipping of their products, particularly regarding the allowance for minor excursions from the labeled storage conditions....
- [Industry/Regulator Forums Point to Role of Glass Suppliers in Injectable QbD](https://ipq.org/industryregulator-forums-point-to-role-of-glass-suppliers-in-injectable-qbd/) - The complex issues around glass quality and drug product interactions bring into high relief the need for container suppliers to be directly involved in the implementation of quality by design (QbD) for injectables....
- [USP is Revising its Compendia in Response to Injectable Product Glass Issues and Plastics Usage](https://ipq.org/usp-is-revising-its-compendia-in-response-to-sterile-product-glass-problems-and-plastics-usage/) - The particulate and reactivity issues that have been surfacing involving drugs and biologics in glass containers and the increased interest in polymer alternatives are prompting USP to revise and expand its related compendial standards and guidance....
- [Breakage and Particle Problems in Glass Vials and Syringes Spurring Industry Interest in Plastics](https://ipq.org/breakage-and-particle-problems-in-glass-vials-and-syringes-spurring-industry-interest-in-plastics/) - Breakage and particle problems associated with glass containers and biologic product sensitivities are prompting pharma firms to take a harder look at polymers for their vials and syringes....
- [Incomplete NDA/ANDA Cover Letters Are Causing FDA to Delay Preapproval Inspections](https://ipq.org/incomplete-ndaanda-cover-letters-are-causing-fda-to-delay-preapproval-inspections/) - Incomplete or inaccurate facility information on NDA/ANDA form 356h cover letters are causing decisions on conducting preapproval inspections (PAIs) to be delayed or tabled, FDA field managers are reporting.
- [Draft “DMF” Regulation in China Draws International Pharma Attention](https://ipq.org/chinas-draft-dmf-regulation-drawing-industry-association-attention/) - The filing requirements China is proposing for active pharmaceutical ingredients (APIs) and pharmaceutical “auxiliary materials” – including their mandatory nature and the lack of clarity regarding how changes to the filings will be handled – are areas of concern in international pharma’s assessment of the country’s evolving CMC program....
- [ICH Q11 Nears Final Approval After Comments Prompt Changes in Step 2 Draft](https://ipq.org/ich-q11-nears-final-approval-after-comment-prompt-changes-in-step-2-draft/) - The final version of ICH’s drug substance development and manufacturing guideline Q11 is nearing Step 4 clearance by the regulatory agencies in the three ICH regions following some significant changes the Expert Working Group (EWG) has made to the Step 2 draft based on the comments received....
- [USP MAb General Chapters on Fast Track](https://ipq.org/usp-mab-general-chapters-on-fast-track/) - USP has set an aggressive goal of April, 2012 to complete drafts of a mandatory general chapter () covering critical quality attributes (CQAs) of recombinant therapeutic monoclonal antibodies (MAbs) and an informational general chapter () addressing a broader range of monoclonal manufacturing and control issues....
- [ICH “Points to Consider” Part Two on Implementing Q8-10 Addresses Models, Design Space and Process Validation](https://ipq.org/ich-points-to-consider-part-2-on-implementing-q8-10-addresses-models-design-space-and-process-validation/) - ICH has released the second half of its “Points to Consider” (PTC) on implementing Q8-10 with advice on: ● the use of models ● development of design space as part of the control strategy, and ● the use of process validation and continuous verification strategies....
- [FDA and EMA Formalize Mutual Inspection Reliance Program](https://ipq.org/fda-and-ema-announce-inspection-data-sharing-program/) - FDA and EMA have formalized a program for relying upon each others' facility inspection data beginning in January in an effort to better utilize agency resources and avoid duplicate work following two successful joint inspection pilots...
- [Generic Drug User Fee Act Nearing Finalization](https://ipq.org/fda-generic-drug-user-fee-act-nearing-finalization/) - The draft of the Generic Drug User Fee Act (GDUFA) entered its last lap in December before going to Congress for approval with a final public airing of FDA’s “goals letter” at its White Oak, Maryland headquarters that produced little public comment. Written comments on the draft “goals letter” are due by January 6, 2012....
- [Several Drug Substance Guideline Initiatives Moving Forward in Europe and ICH](https://ipq.org/several-drug-substance-guideline-initiatives-moving-forward-in-europe-and-ich/) - Europe and ICH have several guideline initiatives underway that will help clarify and harmonize the regulatory expectations for drug substances and the control of their impurities....
- [Look Forward, Not Backward, in API Process for Impurity Risks, Industry Experts Urge EU Regulators](https://ipq.org/look-forward-not-backward-in-api-process-for-impurity-risks-industry-experts-urge-eu-regulators/) - API industry experts are urging European regulators to focus on the risks from impurities that enter at the end of the API synthesis process rather than on earlier pre-intermediate stages where the risks may be considerably less and fully mitigated by later processing....
- [USP Announces New Pharmaceutical QC Training Center in Africa; IOM Report Details Regulatory Shortfalls in Region](https://ipq.org/usp-announces-new-pharmaceutical-qc-training-center-in-africa-iom-report-details-regulatory-shortfalls-in-region/) - USP is planning to extend its effort to help Africa better assure the quality and integrity of its pharmaceutical supply with a new USP training/laboratory center slated to be located in Ghana....
- [Bolus of FDA Warning Letters to Foreign Manufacturers Spans Regions and Product Types](https://ipq.org/bolus-of-fda-warning-letters-to-foreign-manufacturers-spans-regions-and-product-types/) - During a two-week period in late February and early March, FDA’s drug compliance office issued a bolus of six warning letters to foreign manufacturers that span across regions and product types, including two each on active pharmaceutical ingredients (APIs), over-the-counter (OTC) solutions and injectables....
- [Biopharm Modeling and Continuous Manufacturing Will Help Drive Vertex' Drug Development and QbD](https://ipq.org/vertex-pursuing-biopharmaceutical-modeling-and-continuous-manufacturing-to-help-drive-drug-development-and-qbdb/) - Vertex is focusing on biopharmaceutics modeling and continuous manufacturing as potentially powerful tools for advancing its drug development and quality by design (QbD) program....
- [Safety Assurance in Focus at FDA Hearing on Biosimilar Guidance and Policy Refinement](https://ipq.org/safety-assurance-in-focus-at-fda-hearing-on-biosimilar-guidance-and-policy-refinement/) - The balance point between wider patient access and safety assurance was among the issues receiving particular attention at a public hearing held by FDA in May to get further feedback on where it needs to go in its regulation of biosimilars....
- [FDASIA’s Catch-All Title XI Includes Provisions on Medical Gases and Nanomaterials](https://ipq.org/fdasias-catch-all-title-xi-includes-provisions-on-medical-gases-and-nanomaterials/) - A new system for the registration of medical gases and FDA participation in standard setting for nanotechnology particle-containing products are among the provisions in the catch-all Title XI of the Food and Drug Administration Safety and Innovation Act (FDASIA) that will further the Act’s impact on CMC and GMP regulatory processes....
- [New OGD Director Geba May Take the Helm of a Super Office; CDER Director Woodcock Sharpening Center’s Quality Focus](https://ipq.org/new-ogd-director-geba-may-take-the-helm-of-a-super-office-cder-director-woodcock-sharpening-centers-quality-focus/) - The new director of the Office of Generic Drugs (OGD) will likely take the helm of a new FDA “super office,” being proposed to reflect the heightened focus on generic drug regulation and the challenges posed by an increasing number of applications and the passage of the Generic Drug User Fee Amendments (GDUFA)....
- [Mass. Closes More Compounders; Grand Jury Probes NECC; New Infection Types Reported; FDA Reaches out to States](https://ipq.org/massachusetts-closes-more-compounders-as-inspections-ramp-up-grand-jury-probes-necc-new-infection-types-reported-hamburg-reaches-out-to-states/) - The State of Massachusetts has closed three more compounding pharmacies in the wake of its ramping up of oversight of those making sterile injectables....
- [Sponsor/CMO Communication Gaps Will Have Negative Inspection Fallout, FDA Field Investigator Cautions](https://ipq.org/sponsorcmo-communication-gaps-will-have-negative-inspection-fallout-fda-field-investigator-cautions/) - The lack of communication between sponsors and contract manufacturing organizations (CMOs) – particularly those located abroad – can make the FDA inspection process a difficult one and can jeopardize the compliance position of the CMO involved as well as the approval of the sponsor’s application, agency investigators are warning....
- [Special Report: IPQ Top Ten Stories for 2012](https://ipq.org/special-report-ipq-top-ten-stories-for-2012-now-available/) - To kick off the New Year, IPQ is providing a compilation of the ten stories that generated the largest readership in 2012....
- [Hospira Takes QbD Approach to Compliance Remediation Efforts While Production Continues](https://ipq.org/hospira-takes-qbd-approach-to-compliance-remediation-efforts-while-production-continues/) - Hospira is taking a quality by design-oriented approach to compliance remediation and quality improvement at its key Rocky Mount, North Carolina injectable manufacturing facility – focusing more heavily on identifying and monitoring critical process steps than on reviewing batch records....
- [Search Intensifies for Options to Resource-Draining Redundancies of Multiple Agency Inspections](https://ipq.org/search-intensifies-for-options-to-resource-draining-redundancies-of-multiple-agency-inspections/) - A road map of previous regulatory inspections and their results is among the ideas being voiced by industry that could help avoid resource-draining inspection redundancy by different agencies and rationalize GMP regulation internationally....
- [Burden of Pre-Inspection Submission Requests from Agencies Outside the US and Europe is Growing](https://ipq.org/burden-of-pre-inspection-submission-requests-from-non-useu-agencies-is-growing/) - Pharma industry experts are expressing concern with a new trend of emerging country agencies requesting significant amounts of manufacturing and facility information prior to performing GMP inspections and are proposing that the international community work toward a more clearly-defined, manageable and harmonized approach....
- [FDA Releases Draft Guidance on ANDA Content and Format as Efforts Continue to Clarify and Streamline Review Process Under GDUFA](https://ipq.org/fda-releases-draft-guidance-on-anda-content-and-format-as-efforts-continue-to-clarity-and-streamline-review-process-under-gdufa/) - A draft guidance on the content and format of abbreviated new drug applications (ANDAs) is the most recent effort by the Office of Generic Drugs (OGD) to clarify and streamline the ANDA process and facilitate the implementation of the Generic Drug User Fee Act (GDUFA). The draft was released in mid-June for a 60-day comment period....
- [Pharma Manufacturers are Making Progress Down the Six Sigma Pathway](https://ipq.org/pharma-manufacturers-are-making-progress-down-the-six-sigma-pathway/) - Pharmaceutical manufacturers are starting to find the process-capability holy grail of six sigma – a goal that many thought not long ago was unattainable for pharma. In applying the Deming principles of variability reduction and organizational understanding, manufacturers are reporting substantial decreases in waste, process deviations, and inventory that translate into several hundred million dollars
- [EDQM’s International API Convergence Efforts Encompass Generics Regulator Forum IGDRP, Monographs and Inspections](https://ipq.org/edqms-international-convergence-efforts-target-generic-drugs-through-regulator-forum-igdrp-monographs-and-inspections/) - The efforts by the European Directorate for the Quality of Medicines (EDQM) to further API quality regulatory harmonization include its participation in the International Generic Drug Regulators Program (IGDRP), which released in March a common form for submitting drug master files for active substances (ASMF/DMF), a common template for reviewing them, and a lexicon of common
- [Vertex Sheds Light on Continuous Manufacturing Approval and Post-Approval Challenges](https://ipq.org/vertex-sheds-light-on-continuous-manufacturing-approval-and-post-approval-challenges/) - The detection and segregation of non-conforming materials and the justification of sampling plans and locations will be key regulator concerns in reviewing the control system for continuous manufacturing (CM) operations, Vertex is advising based on its experience as the first company to have gone through the CM clearance process at FDA. Vertex experts also emphasize
- [New and Generic Drug User Fees, 21st Century Cures Act, Fuel FDA Regulatory Process and Culture Changes for Combination Products](https://ipq.org/fda-new-and-generic-drug-user-fees-21st-century-cures-act-fuel-regulatory-process-and-culture-changes-for-combination-products/) - The process of reauthorizing user fees for new and generic drug products has afforded the Center for Drug Evaluation and Research (CDER) the opportunity to work cooperatively with industry to drive significant cultural and process enhancements in its regulation of drug/biologic/device combination products. Commitments related to improving the regulatory process for combination products are built
- [Janssen Highlights Value of Academic Collaboration in Move to Continuous Manufacturing](https://ipq.org/janssen-highlights-value-of-academic-collaboration-in-move-to-continuous-manufacturing/) - Janssen scientists involved in the successful transition from batch to continuous manufacturing (CM) for its anti-HIV product Prezista are forthright in their recognition of the role played by academia – especially Rutgers University – in addressing the technical and regulatory challenges. The Rutgers team have been appearing alongside their Janssen collaborators at a series of
- [Biopharma Is Working with Analytics Providers and Government Agencies to Further Multi-Attribute Method Use in QC](https://ipq.org/biopharma-is-working-with-analytics-providers-and-government-agencies-to-further-multi-attribute-method-use-in-qc/) - Biopharmaceutical manufacturers are seeking to expedite the process of taking multi-attribute methodology (MAM) from the development to the quality control (QC) arena and are working with analytics providers and government agencies to help address the challenges involved. Having shown the effectiveness of the mass spectrometry-based MAM in improving biomolecule characterization, design and development, the push
- [Expanding Field of Advanced Therapies Puts Pressure on FDA’s Review Staff to Keep Pace](https://ipq.org/expanding-field-of-advanced-therapies-puts-pressure-on-fdas-review-staff-to-keep-pace-2/) - Regulators facing the diversity and complexity of advanced therapies are being challenged with achieving the right balance between providing the regulatory flexibility needed to foster their development and assuring that CMC processes are in place to maximize product safety and avoid the mishaps that could significantly derail their progress. Agencies like the US FDA are
- [semler](https://ipq.org/semler/) - Notification to Pharmaceutical Companies: Clinical and Bioanalytical Studies Conducted by Semler Research are Unacceptable [4/20/2016] FDA is notifying sponsors of New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) that clinical and bioanalytical studies conducted by Semler Research Private Limited (Semler) located in Bangalore, India, are not acceptable as a result of data integrity concerns, and need
- [FDA Seeking Industry Input on Quality Metrics to Help Rationalize Its Review and Inspection System](https://ipq.org/fda-seeking-industry-input-on-quality-metrics-to-help-rationalize-its-review-and-inspection-system/) - FDA is proposing that the application of the right quality metrics could help create a more flexible and rationalized review and inspection system and is asking for industry input on what metrics would provide the most effective leverage....
- [U.S. and Five Other Countries Await Listing Decision Under EU’s Falsified Medicines Directive](https://ipq.org/fda-seeks-listing-under-eus-falsified-medicines-directive/) - The U.S. is among six countries with applications pending at the European Commission (EC) to be listed as a third country with GMPs equivalent to those in force in the EU, which allows continued export of active pharmaceutical ingredients (APIs) into the EU without a company-specific certification under the terms of the EU’s Falsified Medicines
- [ASEAN Adopting QbD Approach to Process Validation Under Singapore Leadership](https://ipq.org/asean-adopting-qbd-approach-to-process-validation-under-singapore-leadership/) - Singapore is leading an effort by the Association of Southeast Asian Nations (ASEAN) to achieve a harmonized approach to process validation modeled on FDA’s lifecycle approach and the ICH Q8-10 paradigm it embodies....
- [API Switch in OTC Cough Syrup Kills at Least 60 in Pakistan and India](https://ipq.org/api-switch-in-otc-cough-syrup-kills-at-least-60-in-pakistan-and-india/) - The World Health Organization (WHO) reported in an “information exchange system alert” issued in late January that cough syrup manufactured in India using an incorrect raw material has resulted in the deaths of at least 60 people in Pakistan and India. The incidents occurred in November and December and were linked to cough syrup produced
- [FDA Releases Final Guidance on PET Drug INDs](https://ipq.org/fda-final-guidance-on-ind-applications-for-pet-drugs-differs-little-from-draft/) - FDA has released a final guidance on Investigational New Drug (IND) Applications for Positron Emission Tomography (PET) Drugs that updates a draft released in February with only minor changes. The guidance summarizes the IND process for unapproved PET drugs, makes recommendations on how to submit an IND, provides advice on investigational PET drug access options,
- [India Publishes Guidelines for API Export into the EU Under the FMD](https://ipq.org/indian-trade-group-pharmexcil-publishes-guidelines-for-exporting-api-into-eu/) - The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has released procedures from the country’s Central Drug Standards Control Organization (CDSCO) for how Indian active pharmaceutical ingredient (API) manufacturers can obtain a written confirmation of quality that will be needed to ship their products to the EU. Pharmexcil, which was set up by India’s Ministry of
- [IPQ Top Ten Stories for 2012](https://ipq.org/special-report-ipq-top-ten-stories-for-2012/) - To kick off the New Year, IPQ is providing a compilation of the ten stories that generated the largest readership in 2012.
- [FDA’s Draft ANDA Stability Guidance Applies ICH Expectations to Generics](https://ipq.org/fdas-draft-anda-stability-guidance-applies-ich-expectations-to-generics/) - The Office of Generic Drugs (OGD) has released a new draft guidance indicating that Abbreviated New Drug Applications (ANDAs) and the Drug Master Files (DMFs) that support them will be expected to follow the stability recommendations provided in the ICH Q1A-E stability guidelines....
- [EMA Releases Final Active Substance Master File Guideline](https://ipq.org/ema-releases-final-active-substance-master-file-guideline/) - EMA’s recently released final active substance master file (ASMF) guideline remains largely unchanged from the draft issued for comment in January. The guideline is effective in October 2012. The January draft, in turn, represented a rewrite of a 2006 draft, and was aimed at creating unique versions of ASMFs for each active substance that will
- [Pharma May be Missing 80% of the Power of Deming’s Methods, Deming Institute Expert Maintains at PDA/FDA Q10 Workshop](https://ipq.org/pharma-may-be-missing-80-of-the-power-of-demings-methods-deming-institute-expert-maintains-at-pdafda-q10-workshop/) - Deming Institute Advisory Board Chairman Kelly Allen maintained at a PDA/FDA Pharmaceutical Quality System (ICH Q10) Workshop on Quality Risk Management that the pharmaceutical industry has, in general, been missing 80% of the power of Deming’s management methods, which involve understanding: ● the organization as a system ● variation ● the theory of knowledge, and ● human psychology....
- [APIC is Mapping API Requirements in Emerging Countries and Working with Them to Create More Transparent, Efficient, and Harmonized Regulatory Processes](https://ipq.org/apic-is-mapping-emerging-country-api-requirements-and-working-with-them-to-create-more-transparent-efficient-and-harmonized-regulatory-processes/) - The Europe-based Active Pharmaceutical Ingredients Council (APIC) is mapping out the current API registration requirements in emerging countries, defining best practices, and developing strategies for working with the various authorities on creating more transparent, efficient and harmonized regulatory processes....
- [Part 11 “Add-on” Coverage to FDA Surveillance Inspections Shedding Light on Industry Gaps](https://ipq.org/part-11-add-on-coverage-to-fda-surveillance-inspections-shedding-light-on-industry-gaps-2/) - FDA is getting a better handle on where industry is having problems applying Part 11 as the results from its “add-on” coverage of computer systems during routine surveillance inspections begin to emerge....
- [WHO, USP and PDA Make Substantial Contributions to GDP Guidance Canon](https://ipq.org/who-usp-and-pda-make-substantial-contributions-to-gdp-guidance-canon/) - The international pharmaceutical community is continuing to expand and refine its guidance for good distribution practices (GDPs) to give industry the tools it needs to protect and assess product quality in the face of the many hazards of a complex global supply chain....
- [The Role of QbD in ANDA Review Draws Comment from Generics Office Management](https://ipq.org/the-role-of-qbd-in-anda-review-draws-comment-from-generics-office-management/) - FDA’s Office of Generic Drugs (OGD) is advising industry that consistency around key quality-by-design (QbD) terminology will help release the potential of QbD to facilitate the Abbreviated New Drug Application (ANDA) review process....
- [New CDER Compliance Super Office Structure Reflects Emerging Global Supply Chain Threats](https://ipq.org/new-cder-compliance-super-office-structure-reflects-emerging-global-supply-chain-threats/) - FDA’s Center for Drug Evaluation and Research (CDER) is elevating and restructuring its Office of Compliance (OC) to better reflect the regulatory challenges posed by an increasingly complex global supply chain and the recent growth of the office’s staff and responsibilities....
- [EU Biological Product GMPs Will Expand in Breadth and Depth With New Annex 2](https://ipq.org/eu-biological-product-gmps-will-expand-in-breadth-and-depth-with-new-annex-2/) - The soon-to-be finalized overhaul of EU GMP Annex 2 will significantly expand the breadth and depth of its coverage of the manufacture of biological products and will bring advanced therapy medicinal products (ATMPs) and those transgenically-derived under its umbrella....
- [ASEAN Effort Progressing on CMC/GMP Harmonization, But Differences Remain](https://ipq.org/asean-effort-progressing-on-cmcgmp-harmonization-but-differences-remain/) - An analysis of the CMC/GMP regulatory framework among the Association of South East Asian Nations (ASEAN) shows significant progress in moving toward a more cohesive and harmonized approach, although differences remain in individual country requirements and procedures....
- [FDA Extends False Claims Act to GMP Violations in $750 Million GSK Settlement](https://ipq.org/fda-extends-false-claims-act-to-gmp-violations-in-750-million-gsk-settlement/) - The Department of Justice (DoJ) announced in late October that SB Pharmco Puerto Rico (PR) – a subsidiary of GlaxoSmithKline (GSK) – has agreed to plead guilty to charges relating to the manufacture and distribution of adulterated drugs produced between 2001 and 2005 at its now-closed Cidra, PR facility....
- [MHRA Publishes Inspection Findings Summary; EMA Discontinues Publication of “Top 40” list](https://ipq.org/mhra-publishes-inspection-findings-summary-ema-discontinues-publication-of-top-40-list/) - At an “OOS Forum 2012” in mid-June in Prague, Czechoslovakia, sponsored by the European Compliance Academy (ECA) in cooperation with Europe’s QP Association, UK Medicines and Healthcare products Regulatory Agency (MHRA) GMP inspector Di Morris presented her agency’s top ten findings from GMP inspections between April 2011 and March 2012 (link provided below). MHRA’s annual
- [Legislation Introduced to Provide FDA Mandatory Recall Authority for Human and Animal Drugs](https://ipq.org/legislation-introduced-to-provide-fda-mandatory-recall-authority-for-human-and-animal-drugs/) - Chairman Edolphus Towns (D-NY) announced that he has introduced H.R. 5740, “a bill to provide for the mandatory recall of adulterated or misbranded drugs,” that would amend the Federal Food, Drug and Cosmetic Act (FD&C Act), to provide new recall authority to FDA....
- [CBER Releases Updated Compliance Program Guide on Inspection of Biological Drug Products](https://ipq.org/cber-releases-updated-compliance-program-guide-on-inspection-of-biological-drug-products/) - The Center for Biologics Evaluation and Research (CBER) released in June a revised version of its Compliance Program Guidance (CPG) 7345.848, “Inspection of Biological Drug Products,” which combines and replaces previous versions of CPGs covering related biological products and provides inspectional guidance to investigators for conducting biennial or for-cause inspections across the biologics spectrum....
- [New FDA Draft Guidance Reduces Reporting Burden for CMC Postapproval Changes](https://ipq.org/new-fda-draft-guidance-reduces-reporting-burden-for-cmc-postapproval-changes/) - A new draft guidance from FDA specifies 40 types of low-risk manufacturing changes that will now quality for annual report filing and represents a significant step in the agency’s effort to reduce the number of supplements that have to funnel through the Center for Drug Evaluation and Research (CDER) clearance process....
- [FDA Fast-Tracking Supply Chain cGMP Upgrades; Other GMP Changes, Quality Agreement Guidance Taking Shape](https://ipq.org/fda-fast-tracking-supply-chain-cgmp-upgrades-other-gmp-changes-quality-agreement-guidance-taking-shape/) - FDA is fast-tracking a set of changes to 21 CFR Part 211 targeting control of raw materials, excipients and components used in pharmaceutical manufacturing. Also being completed are changes impacting management responsibilities, self-inspections, defect investigations, change control, training documentation, and use of purified water in manufacturing....
- [QbD is Changing the Quality Regulatory Landscape in the US and EU](https://ipq.org/qbd-is-changing-the-quality-regulatory-landscape-in-the-us-and-eu/) - The quality regulatory initiatives underway as the new decade begins show the strong imprint of ICH Q8-10 at both the agency and international levels. The May 2010 issue of International Pharmaceutical Quality (IPQ) provides an in-depth analysis of how quality by design and the new Q8-10 paradigm is transforming the quality regulatory landscape....
- [EMA Updates Facility Inspection Procedures to Align with EU GMP Guide Revisions](https://ipq.org/ema-updates-facility-inspection-procedures-to-align-with-eu-gmp-guide-revisions/) - The European Medicines Agency (EMA) has updated its GMP facility inspection procedures to align with recent revisions to its EU GMP Guide reflective of ICH Q8-10 principles....
- [FDA Adjusts Its Pre-approval Inspection Guide To Reflect ICH Q8-10 Paradigm](https://ipq.org/fda-adjusts-its-pre-approval-inspection-guide-to-reflect-ich-q8-10-paradigm/) - FDA has updated its pre-approval inspection (PAI) compliance program guidance (CPG 7346.832) to better reflect the agency’s 21st century quality initiative and the new ICH Q8-10/QbD regulatory paradigm….
- [FDA Shares Concerns, Expectations Regarding Pharma Cargo Thefts](https://ipq.org/fda-shares-concerns-expectations-regarding-pharma-cargo-thefts/) - FDA sent a letter to medical companies expressing concern about the increase in cargo thefts of FDA-regulated drug products, and clarifying its expectations from companies and the agency’s role when thefts occur....
- [Draft Revision of EU Annex 2 For Biologicals Out For Comment](https://ipq.org/draft-revision-of-eu-annex-2-for-biologicals-out-for-comment/) - The European Commission has published a revised draft of Volume 4, Annex 2, “Manufacture of Biological Medicinal Substances and Products for Human Use.” This revision is taking place due in part to the need to include an increased range and complexity of biological products, and new products such as advanced therapy medicinal products....
- [McNeil Voluntary Plant Shutdown, Product Recalls Follow FDA Inspection](https://ipq.org/mcneil-voluntary-plant-shutdown-and-multi-product-recalls-follow-fda-inspection/) - On April 30, McNeil Consumer Healthcare, the OTC division of J & J, announced a recall of about 1,500 lots of liquid infant’s and children’s Tylenol, Motrin, Zyrtec and Benadryl, and voluntarily shut down the plant where they were manufactured at the end of a two-week FDA inspection at their Fort Washington, PA facility....
- [MHRA is Requiring Interim Update Reports for Risk-Based Inspections](https://ipq.org/will-a-link-work-on-front-page-news-item/) - MHRA is requesting that all manufacturing sites inspected after April 1, 2009 under its risk-based inspection (RBI) approach submit interim updates to communicate significant changes between inspections....
- [Propofol Shortage Follows Teva and Hospira Warning Letters and Recalls](https://ipq.org/fda-issues-warning-letter-to-teva/) - European manufacturer Fresnius is stepping in to help fill the US shortage in the injectible anaesthetic propofol caused by GMP problems at Teva and Hospira, resulting in warning letters and recalls. FDA's lengthy warning letter to TEVA in December, posted in April, focused on the manufacture of their generic version of propofol, and primarily related to microbial contamination and testing, including endotoxin in distributed product....
- [Preparing for CMC Changes is Difficult but Pivotal to Accelerating CGT Development, Industry Experts Are Stressing](https://ipq.org/preparing-for-cmc-changes-is-difficult-but-pivotal-to-accelerating-cgt-development-industry-experts-are-stressing/) - Cell and gene therapy (CGT) sponsors are wrestling hard with how to prepare for having to make CMC changes throughout the development, submission, and post-approval stages, while facing accelerated timeframes and significant knowledge limitations.
- [CBER Reviewers Are Working with Sponsors in Exploring CMC Flexibility for Cell and Gene Therapies](https://ipq.org/cber-reviewers-are-working-with-sponsors-in-exploring-cmc-flexibility-for-cell-and-gene-therapies/) - Reviewers with FDA’s Center for Biologics Evaluation and Research (CBER) are working with sponsors to determine how and where flexibility can be applied in the type and extent of CMC information expected at the time of cell and gene therapy (CGT) product submissions.
- [CBER and CDER Directors Offer Insights on Overcoming Hurdles to Biomanufacturing Innovation at NIIMBL Annual Meeting](https://ipq.org/cber-and-cder-directors-offer-insights-on-overcoming-hurdles-to-biomanufacturing-innovation-at-niimbl-annual-meeting/) - Among the ways that public/private collaborations could play a critical role in advancing cell and gene therapy (CGT) manufacturing would be helping create a non-proprietary set of adeno-associated virus (AAV) vectors, CBER Director Peter Marks proposed at the third annual meeting of the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), held in Crystal City
- [Regulators and Industry Are Probing More Deeply into the Complexities of Preservative Usage](https://ipq.org/regulators-and-industry-are-probing-more-deeply-into-the-complexities-of-preservative-usage/) - Regulators and industry are exploring more deeply the complex web of issues involved with effective use of preservatives in drug products, as the challenges and the consequences come into clearer view.
- [IPEC Continues to Encourage China to Align with Global Science-Based Excipient Standards](https://ipq.org/ipec-continues-to-encourage-china-to-align-with-global-science-based-excipient-standards/) - Global excipient manufacturers, working through the International Pharmaceutical Excipients Council (IPEC) Federation and IPEC-China, continue to express concern with the divergence of the Chinese Pharmacopeia (ChP) standards from the major global pharmacopeias, and to propose science-based changes that would move the ChP toward better alignment.
- [MHRA Inspectors are Advocating Data Mapping as a Key First Step on the Data Integrity Pilgrimage](https://ipq.org/mhra-inspectors-are-advocating-data-mapping-as-a-key-first-step-on-the-data-integrity-pilgrimage/) - Data process mapping is being strongly encouraged by inspectors from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) as a first step in planning, establishing, and maintaining the controls necessary to secure data integrity.
- [Data Integrity Compliance Experts Are Urging Industry to Apply Regulator Perspective and Learnings in Refining Data Systems and Auditing](https://ipq.org/data-integrity-compliance-experts-are-urging-industry-to-apply-regulator-perspective-and-learnings-in-refining-data-systems-and-auditing/) - Data integrity (DI) regulatory compliance experts are observing that industry in-house and third-party auditors are often not detecting failures because they are not viewing the systems and processes in the same manner as agency inspectors.
- [The Role of Quality Culture in Data Integrity Is Getting More Attention as Regulator and Industry DI Guidances Evolve](https://ipq.org/the-role-of-quality-culture-in-data-integrity-is-getting-more-attention-as-regulator-and-industry-di-guidances-evolve/) - The importance of quality culture is finding more clear expression in the refinement of regulator and industry guidances that have been forthcoming recently on data integrity (DI) and what is required to assure it.
- [Data Integrity Guidance Revisions by FDA and PIC/S Deepen Industry’s DI Resource Pool](https://ipq.org/data-integrity-guidance-revisions-by-fda-and-pic-s-deepen-industrys-di-resource-pool/) - Updated guidances from FDA and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) on maintaining data integrity (DI) across the product lifecycle have deepened the pool of resources that industry now has available to support its DI efforts.
- [Cell and Gene Therapy Initiatives Prominent on Biomanufacturing Agenda of U.S. National Institute of Standards and Technology](https://ipq.org/cell-and-gene-therapy-initiatives-prominent-on-biomanufacturing-agenda-of-u-s-national-institute-of-standards-and-technology/) - The growing need for standards in the rapidly evolving world of biopharmaceuticals and cell and gene therapies (CGTs) is giving rise to an expanding array of collaborative initiatives, products, and processes, many of which are flowing through the U.S. National Institute of Standards and Technology (NIST).
- [FDA’s Focus Has Sharpened on Water Systems in the Wake of Nonsterile Product Microbial Contamination](https://ipq.org/fdas-focus-has-sharpened-on-water-systems-in-the-wake-of-nonsterile-product-microbial-contamination/) - FDA has been sharpening its focus on water systems during inspections of nonsterile liquid products as microbial contamination problems of significance in these products continue to surface.
- [Pharmacopoeia/Industry/Agency Global Dialogue on Compendial Compliance and Harmonization Continues, with Medicine Availability at Stake](https://ipq.org/pharmacopoeia-industry-agency-global-dialogue-on-compendial-compliance-and-harmonization-continues-with-medicine-availability-at-stake/) - Industry, regulatory authorities and pharmacopoeias continue to explore ways to address the difficult challenges of complying with and harmonizing compendial and regulatory requirements in the effort to ensure and enhance the availability of medicines around the world.
- [FDA Investigators Will Focus on Simple GMP Lapses when Inspecting Complex Biotech Systems, Former Compliance Official Cosgrove is Advising](https://ipq.org/fda-investigators-will-focus-on-simple-gmp-lapses-when-inspecting-complex-biotech-systems-former-compliance-official-cosgrove-is-advising/) - Former FDA Center for Drug Evaluation and Research (CDER) senior compliance official Tom Cosgrove, now a partner at the law firm Covington & Burling, is cautioning biotech companies to make sure they are in compliance with the more mundane GMP details, on which investigators will be focused, to keep the regulatory pathway clear for their
- [Technology Roadmapping Leads NIIMBL Project Expansion Across Biopharmaceutical Manufacturing/Analytics/Workforce Landscape](https://ipq.org/technology-roadmapping-leads-niimbl-project-expansion-across-biopharmaceutical-manufacturing-analytics-workforce-landscape/) - Technology roadmaps specific to vaccines, gene therapies, and antibody drug conjugates (ADCs)/bispecifics are the first of the many impactful industry/government/academia collaborative projects in the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) portfolio to reach completion.
- [UK MHRA’s “No Deal” Brexit Preparations Include Role for “Responsible Person – Import”](https://ipq.org/uk-mhras-no-deal-brexit-preparations-include-role-for-responsible-person-import/) - The new role of “Responsible Person – Import” is among the proposals the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has developed through its engagement with stakeholders to prepare for the possibility of an unwanted “no-deal” exit of the UK from the European Union (EU).
- [Retiring FDA Office of Generic Drugs Director Uhl Cautions Industry That Haste Makes Waste in Application Approval Timelines](https://ipq.org/retiring-fda-office-of-generic-drugs-director-uhl-cautions-industry-that-haste-makes-waste-in-application-approval-timelines/) - In offering some of the key learnings from her tenure as Director of FDA’s Office of Generic Drugs, Kathleen “Cook” Uhl is stressing that a “slow” and careful approach by sponsors during the ANDA submission and review process will actually result in faster approvals.
- [CBER’s Compliance Office Absorbing Impact of Cell/Gene Therapy Wave in its Pre-Market and Surveillance Operations](https://ipq.org/cbers-compliance-office-absorbing-impact-of-cell-gene-therapy-wave-in-its-pre-market-and-surveillance-operations/) - The high demands that the review staff is facing at FDA’s Center for Biologics Evaluation and Research from industry’s rapidly expanding engagement with cell and gene therapies (CGTs) is also being felt at CBER’s compliance office on both the pre-market and surveillance side of its operations.
- [FDA’s BLA Review Sheds Light on Evolution of Biotherapeutic Product Analytical Methods and Their Regulation](https://ipq.org/fdas-bla-review-sheds-light-on-evolution-of-biotherapeutic-product-analytical-methods-and-their-regulation/) - Research by FDA’s Office of Biotechnology Products (OBP) into its database and experience with biological license application (BLA) reviews is revealing a lot about the evolving landscape of biotherapeutic product analytical methods and regulatory expectations.
- [Foreign Inventory Completion, Faster Inspection Follow-up Among CDER Compliance Office 2018 Achievements; API, OTC Process Findings Spotlighted](https://ipq.org/foreign-inventory-completion-faster-inspection-follow-up-among-cder-compliance-office-2018-achievements-api-otc-process-findings-spotlighted/) - The Center for Drug Evaluation and Research (CDER) Office of Compliance (OC) is reporting that during FY 2018 FDA nearly completed the inspections of its foreign manufacturing inventory – a full year earlier than agreed to with the General Accounting Office (GAO).
- [Refined Training, Project Selection, and Membership Processes Strengthen ICH’s Global Harmonization Efforts](https://ipq.org/refined-training-project-selection-and-membership-processes-strengthen-ichs-global-harmonization-efforts/) - Refined processes for training, project selection and membership are strengthening ICH’s ability to realize in practice the global harmonization objectives of its guideline development efforts, ICH leaders are affirming.
- [IPEC Digesting Implications of China’s Ending of Separate Excipient Approval Process](https://ipq.org/ipec-digesting-implications-of-chinas-ending-of-separate-excipient-approval-process/) - The International Pharmaceutical Excipients Council (IPEC) is working with its members and China’s Center for Drug Evaluation [CDE] to digest and manage the implications of the decision in China to switch from a separate approval process for pharmaceutical excipients to submission and review of an excipient dossier together with a drug application.
- [Diverging Regional Excipient Regulations Are Creating Problems For Excipient Manufacture, Distribution and Use Globally](https://ipq.org/diverging-regional-excipient-regulations-are-creating-problems-for-excipient-manufacture-distribution-and-use-globally/) - A review of the way excipients are regulated by agencies around the world reveals that regional regulations continue to proliferate and the differences are creating problems for the manufacture, distribution and use of excipients globally.
- [Novel Excipients, DMFs, and Atypical Actives Among Pressing Issues on IPEC-Americas’ Front Burner](https://ipq.org/novel-excipients-dmfs-and-atypical-actives-among-pressing-issues-on-ipec-americas-front-burner/) - Novel excipients, drug master files (DMFs), and atypical actives are among the pressing issues on which the International Pharmaceutical Excipients Council (IPEC) is actively engaged with the major regulatory agencies and standards organizations around the world. In her opening remarks at the 2018 ExcipientFest conference in San Juan, Puerto Rico at the beginning of May, Dow
- [Experience with In Vitro Fertilization Clinics Raises Strong Warnings on Cell Culture/Processing Air Purification](https://ipq.org/experience-with-in-vitro-fertilization-clinics-raises-strong-warnings-on-cell-culture-processing-air-purification/) - Experience with in vitro fertilization (IVF) clinics is sending a strong signal that applying significantly heightened air purification standards and more advanced technology to meet them may be critical across all cell culture/processing operations.
- [Faster Inspection Follow-Up, Global Workload, Draw CDER Compliance Office Attention as 2018 Approaches](https://ipq.org/faster-inspection-follow-up-global-workload-draw-cder-compliance-office-attention-as-2018-approaches-2/) - The impact of FDA’s foreshortened inspection classification timelines, as prescribed by the second installment of the Generic Drug User Fee Act (GDUFA II), will include placing additional weight on the quality of the 15-day inspection responses, agency compliance officials are noting. GDUFA II calls for surveillance inspections to be classified within 90 days of their
- [NIST is at Intersection of Industry/Government/Academia Efforts to Support the “Ecosystem” Needed for Cell/Gene Therapy Advancement](https://ipq.org/nist-is-at-intersection-of-industrygovernmentacademia-efforts-to-support-the-ecosystem-needed-for-cellgene-therapy-advancement/) - The U.S. National Institute of Standards & Technology (NIST) is among the organizations rising up across the industry/government/academia spectrum to support the complex “ecosystem of capabilities” needed to develop, manufacture and deliver cell and gene therapies (CGTs). NIST Biosystems and Biomaterials Division Chief Anne Plant had a chance to explore the challenges that exist in
- [Continuous Manufacturing is Driving More Focus on Excipient Fitness for Purpose](https://ipq.org/continuous-manufacturing-is-driving-more-focus-on-excipient-fitness-for-purpose/) - The deployment of continuous manufacturing (CM) is prompting the pharmaceutical industry to understand better the characteristics of the excipients they are using and work more closely with suppliers to assure that the materials are fit for purpose. CM is also prompting a harder look at how to open up the clearance pathway for new/modified excipients
- [CDER Offering More Concrete Advice on Continuous Manufacturing as Experience Grows](https://ipq.org/cder-offering-more-concrete-advice-on-continuous-manufacturing-as-experience-grows/) - FDA’s Office of Pharmaceutical Quality (OPQ) has gained enough experience in interacting with industry on implementing continuous manufacturing (CM) operations to be able to offer more concrete advice on the considerations that warrant extra attention. One of OPQ’s primary objectives is to encourage the development and adoption of emerging technologies, and the office has been
- [Strengthening Biotherapeutic Regulation Worldwide Will Remain a High Priority for WHO in 2017](https://ipq.org/strengthening-biotherapeutic-regulation-worldwide-will-remain-a-high-priority-for-who-in-2017/) - Strengthening the capacity of governments around the world to regulate biotherapeutics and biosimilars in the effort to increase patient access to high quality products will remain a key priority for the World Health Organization (WHO) in 2017. Underpinning the increased focus WHO is placing on biotherapeutic product regulation and access are resolutions passed by WHO’s
- [CDER’s Office of Biotechnology Products Sheds Light on Biosimilar CMC Challenges and Solutions](https://ipq.org/cders-office-of-biotechnology-products-sheds-light-on-biosimilar-cmc-challenges-and-solutions/) - While cautioning industry that developing a biosimilar remains a challenging marathon, FDA’s Office of Biotech Products (OBP) is now able to offer a lot more concrete advice on what it takes to cross the finish line. OBP has been fully engaged in the intensive assessment that the agency has been doing of its growing body
- [User Fee Reauthorization Prompts More Intensive FDA Assessment of Its Growing Biosimilar Regulatory Experience](https://ipq.org/user-fee-reauthorization-prompts-more-intensive-fda-assessment-of-its-growing-biosimilar-regulatory-experience/) - The Biosimilar User Fee Act (BsUFA) reauthoritization process has driven an intensive assessment by FDA of its growing body of regulatory experience to determine where the difficulties have been in the first five years of the user fee program and what can be done to address them. The current initial authorization for collecting the biosimilar user
- [Review/Inspection Control Strategy Communications Key in Advancing Biotech Regulation, FDA Biotech Official Stresses](https://ipq.org/reviewinspection-control-strategy-communications-key-to-advancing-biotech-regulation-fda-biotech-official-stresses/) - Biotech product and process knowledge has created the foundation for regulatory changes, but close communication and coordination between manufacturers and regulatory agencies will be necessary to realize those changes while ensuring and advancing product quality, FDA Center for Drug Evaluation and Research (CDER) Office of Biotechnology Products (OBP) Review Chief Sarah Kennett emphasized at the
- [More Clarity Sought in FDA’s Inactive Ingredient Database Regarding Drug Delivery Devices](https://ipq.org/14018/) - FDA and the excipient industry are giving more thought to how the inactive ingredient database (IID) can be improved to better support the development of emerging dosage forms, including drug delivery devices such as transdermal patches, metered dose inhalers, nasal sprays, and implants. A session was held at the 2016 IPEC-Americas/ExcipientFest Conference, held in late
- [Procedures, Eligibilities and Goals of EMA’s Accelerated Access Efforts Are Taking More Concrete Shape](https://ipq.org/procedures-eligibilities-and-goals-of-emas-accelerated-access-efforts-are-taking-more-concrete-shape/) - The procedures, eligibilities and goals of EMA’s accelerated access approaches for new medicines that fill unmet medical needs, including “Priority Medicines” (PRIME) and “Adaptive Pathways” (AP), have been taking more concrete shape, informed by the European agency’s growing implementation experience. Since March 2016, there has been a wave of EMA releases on the different facets
- [FDA Efforts Continue to Make its Inactive Ingredient Database More Functional](https://ipq.org/fda-efforts-continue-to-make-its-inactive-ingredient-database-more-functional/) - FDA’s Office of Pharmaceutical Quality (OPQ) is sharpening its vision of how to increase the reliability and user input in its Inactive Ingredient Database (IID) to make it more beneficial to both internal and external users. The ongoing improvement efforts include eliminating the backlog of entries, refining the data collection and change processes, and standardizing
- [Continuous Manufacturing/QbD Relationship Explored by Industry and Regulators at FDA/PQRI Conference](https://ipq.org/continuous-manufacturingqbd-relationship-explored-by-industry-and-regulators-at-fdapqri-conference/) - The impact of continuous manufacturing (CM) on the ability of pharma to fully implement quality by design (QbD) and realize its benefits is becoming clear as the technology moves into full operation. The potential for QbD to come to fruition in the process understanding- and data-rich environment of continuous manufacturing was highlighted by both FDA
- [IPEC Continues to Urge Family Approach in Dialogue with FDA on Improving Inactive Ingredient Database](https://ipq.org/ipec-continues-to-urge-family-approach-in-dialogue-with-fda-on-improving-inactive-ingredient-database/) - IPEC-Americas and the Generic Pharmaceutical Association (GPhA) are continuing their advocacy of FDA incorporating a family approach in the toxicology assessment of excipients as they work with the agency on further improving the inactive ingredient database (IID) to support better drug development and more efficient FDA reviews. In a session on the IID at the
- [Risk Assessments, Data Integrity, Documentation, and Deviations Will be High on EU Radar Screen in Auditing Process Validation With Revised GMP Annex 15 In Effect](https://ipq.org/risk-assessments-data-integrity-documentation-and-deviations-will-be-high-on-eu-radar-screen-in-auditing-process-validation-with-revised-gmp-annex-15-in-effect/) - Risk assessments, data integrity, documentation organization and deviation handling are issues that will be high on the radar screen of European inspectors in reviewing how companies are validating their processes, in accord with the increased emphasis the issues have received in the revision of EU GMP Annex 15. Annex 15, which covers the qualification and
- [PIC/S Relationship is Impacting Process Validation Expectations in Asia Pacific Region, Although They Vary in Practice, ISPE’s Asia Network is Reporting](https://ipq.org/pics-relationship-is-impacting-process-validation-expectations-in-asia-pacific-region-although-they-vary-in-practice-ispes-asia-network-is-reporting/) - The strong influence of PIC/S in the Asia Pacific region is impacting the expectations for process validation, although those expectations vary significantly in practice, the ISPE Asia network is reporting. Process validation has been an active area of both benchmarking and training in the ISPE Asia network, which includes 14 affiliates. Valuable insights have
- [Clarifying Questions Upfront is Key in Process Validation, US and EU PV Principles in Alignment, CDER’s McNally Stresses ](https://ipq.org/clarifying-questions-upfront-is-key-in-process-validation-us-and-eu-pv-principles-in-alignment-cders-mcnally-stresses/) - FDA is advising industry to ensure that their process validation teams clearly articulate and document the questions they are seeking to answer up front, prior to collecting data or executing process qualification (PQ). Beginning with the questions in mind and following up with supporting sampling plans and statistical tools will increase the chances for a
- [Wave 2 of ISPE’s Quality Metrics Pilot Will Explore Metric Relationships and How to Deepen Industry’s Role in Advancing the Regulatory Process](https://ipq.org/wave-2-of-ispes-quality-metrics-pilot-will-explore-metric-relationships-and-how-to-deepen-industrys-role-in-advancing-the-regulatory-process/) - Wave 2 of ISPE’s quality metrics pilot is being designed to enhance the understanding of the relationships between the metrics that emerged into relief during Wave 1 and to provide further support for FDA in developing a more data-driven regulatory process. To help enrich the data set and its value, ISPE is seeking to: ●
- [Culture and Process Capability Continue In Focus as FDA Releases Its Draft Quality Metrics Guidance](https://ipq.org/culture-and-process-capability-continue-in-focus-as-fda-releases-its-draft-quality-metrics-guidance/) - FDA is asking for industry input on how quality culture and process capability evaluations can contribute to the “baseline” metrics it has put on the table for review in its draft quality metrics guidance. Released in late July, the draft guidance and the accompanying Federal Register announcement point to the importance of quality culture and
- [Relationship with Excipient Providers Drawing Increasing Pharma Attention, BMS Exec Stresses; IPEC Urges Regulatory Pathway for New Excipients in GDUFA/PDUFA Comments](https://ipq.org/relationship-with-excipient-providers-drawing-increasing-pharma-attention-bms-exec-stresses-ipec-urges-regulatory-pathway-for-new-excipients-in-gdufapdufa-comments/) - An important component in the ability of pharmaceutical innovators to bring their new products to market in the eclipsed timelines in which they need to function will be their relationship with excipient providers, a top manufacturing executive from Bristol-Myers Squibb (BMS) stressed to participants at the International Pharmaceutical Excipients Council of the Americas (IPEC-Americas)/ExcipientFest conference
- [Phased Implementation, Reporting Burden Among Industry Focal Points in Initial Feedback on FDA’s Quality Metrics Draft Guidance](https://ipq.org/phased-implementation-reporting-burden-among-industry-focal-points-in-initial-feedback-on-fdas-quality-metrics-draft-guidance/) - Phased implementation, reporting burden, and the nuances of site versus product reporting were among the focal points of the comments by the various associations appearing at the public meeting held by FDA on August 24 to capture industry’s initial feedback on the agency’s quality metrics draft guidance. Also drawing industry attention at the meeting were
- [High Foreign Inspection Failure Rate Indicates Need for Better Pharma Risk Modeling and Supplier Oversight Abroad, FDA Compliance Official Stresses](https://ipq.org/high-foreign-inspection-failure-rate-indicates-need-for-better-pharma-risk-modeling-and-supplier-oversight-abroad-fda-compliance-official-stresses/) - The current high FDA foreign inspection failure rate points to the need for the pharmaceutical industry to develop better risk models and intensify supplier oversight abroad, a senior official at the Center for Drug Evaluation and Research (CDER) Office of Compliance (OC) is stressing....
- [Implementing the ANSI NSF-IPEC 363 Standard on Excipient GMPs Will Help Ensure Compliance with FDASIA, FMD and EU’s New Excipient Risk Assessment Guideline](https://ipq.org/implementing-the-ansi-nsf-ipec-363-standard-on-excipient-gmps-will-help-ensure-compliance-with-fdasia-fmd-and-eus-new-excipient-risk-assessment-guideline/) - Implementation of the ANSI NSF-IPEC 363 standard on GMPs for excipients by pharma and excipient manufacturers will help ensure that they are compliant with the supply chain mandates of the FDA Safety and Innovation Act (FDASIA), the EU Falsified Medicines Directive (FMD), and the newly-completed EU excipient risk assessment guideline....
- [Fear-based Relationships Antithetical to Progressing Quality Systems, While Measurement is Key, CDER’s Woodcock Stresses at ISPE Metrics Forum](https://ipq.org/fear-based-relationships-antithetical-to-progressing-quality-systems-while-measurement-is-key-cders-woodcock-stresses-at-ispes-metrics-forum/) - The principle that fear-based relationships are antithetical to progressing quality systems is pivotal as FDA reshapes its quality regulatory approach, CDER Director Janet Woodcock is stressing....
- [FDA Urges Improving Characterization, Manufacturing Control, and Potency Assay Design for Cell and Gene Therapies](https://ipq.org/fda-urges-improving-characterization-manufacturing-control-and-potency-assay-design-for-cell-and-gene-therapies/) - FDA is advising companies developing cell and gene therapy (CGT) products to focus on improving the characterization of products, control of the manufacturing process, and design of the related potency assays....
- [ICH’s Lifecycle Management Initiative Q12 is Targeting the Tough Regulatory Issues, With Patient Supply a Driving Concern; Analytical QbD Also on Expanded ICH Agenda](https://ipq.org/ichs-lifecycle-management-initiative-q12-is-targeting-the-tough-regulatory-issues-with-patient-supply-a-driving-concern-analytical-qbd-also-on-expanded-ich-agenda/) - The ICH Q12 effort to create a more improvement-friendly and harmonized regulatory approach to pharmaceutical product lifecycle management is being driven by concern about the availability and reliability of supply as well as product quality and will address the “tough” regulatory issues involved, GSK CMC Regulatory Strategy VP Moheb Nasr stressed in an update on the ICH initiative in December. Nasr has been appointed to serve as Q12 rapporteur....
- [FDA Field Operation 2015 Priorities Include Alignment with Centers and Lab Optimization](https://ipq.org/oras-2015-priorities-include-centerfield-alignment-and-lab-restructuring/) - Top priorities for FDA’s Office of Regulatory Affairs (ORA) in 2015 include closer functional alignment with the agency’s reviewing centers and a major restructuring and optimization of its laboratory operations....
- [Allotrope Analytical Lab Data Standardization Effort Gaining Momentum with Better Analytical and Control Processes at Stake](https://ipq.org/allotrope-analytical-lab-data-standardization-effort-gaining-momentum-with-better-analytical-and-control-processes-at-stake/) - The industry-based Allotrope Foundation is picking up momentum in its ambitious effort to create a framework for standardizing and sharing lab data, with more effective analytical and manufacturing control processes at stake....
- [Allotrope’s Vision of the Laboratory of the Future Aligns Closely with FDA's Regulatory Objectives, Senior Industry Players Maintain](https://ipq.org/allotropes-vision-of-the-laboratory-of-the-future-aligns-closely-with-fda-regulatory-objectives-senior-industry-players-maintain/) - The effort of the Allotrope Foundation to create a common lab data format that is instrument and vendor “agnostic,” allowing for more efficient and compliant analytical and manufacturing control processes, aligns closely with FDA’s lab regulatory objectives, senior industry players involved are stressing....
- [Comment Review, Public Meetings, Supply Chain Pilot to Follow 2014 Bolus of FDA DQSA Track & Trace Guidances](https://ipq.org/public-meetings-supply-chain-pilot-to-follow-2014-bolus-of-fda-dqsa-track-trace-guidances/) - In the wake of having issued a series of guidances in the latter part of 2014 to enable implementation of the 2013 Drug Supply Chain Security Act (DSCSA), FDA is now concentrating on: ● reviewing the comments and finalizing the guidances ● issuing required regulations ● scheduling public meetings ● performing a supply chain pilot program, and ● developing a licensing program for the various trading partners in the supply chain....
- [Advanced Therapy Classification System on Regulatory Front Burner in Europe as Product Wave Builds Globally](https://ipq.org/cellgenetissue-therapy-classification-system-on-regulatory-front-burner-in-europe-as-advanced-therapy-wave-builds-globally/) - As the wave of highly diverse cell/tissue/gene therapies under development continues to build globally, establishing a viable and mutually agreed upon classification system has become a top regulatory priority....
- [FDA’s Center for Veterinary Medicine Using QbR and Other CDER-Tested Approaches to Decrease Review Times; CVM User Fees Drive Guidance Development](https://ipq.org/fdas-center-for-veterinary-medicine-dramatically-decreases-application-review-time-using-question-based-review/) - The use by FDA’s Center for Veterinary Medicine (CVM) of a question-based review (QbR) approach in CMC submissions over the past three years has resulted in significantly decreased review times for both new and abbreviated new animal drug applications (NADAs and ANADAs) for multiple dosage forms, including sterile products – in many cases with the reviews accomplished in a single cycle....
- [Global Excipient Databases Are Advancing That Will Fill Content and Functionality Gaps in Existing Regulatory Efforts and Further Industry/Regulator Communication](https://ipq.org/global-excipient-databases-are-advancing-that-will-fill-content-and-functionality-gaps-in-existing-regulatory-efforts-and-further-industryregulator-communication/) - FDA is working with industry, academia, and other regulators globally on major information management initiatives intended to help industry and regulators communicate about pharmaceutical excipients and fill gaps in existing regulatory database efforts, such as the agency’s Inactive Ingredients Database (IID)....
- [New FDA Biotech Inspection Program Will Mine Ten Years of Industry Data to Enhance Targeting and Execution; Field Refining Risk Ranking Process Across Pharma Spectrum](https://ipq.org/new-fda-biotech-inspection-program-will-mine-ten-years-of-industry-data-to-enhance-targeting-and-execution-field-refining-risk-ranking-process-across-pharma-spectrum/) - The Center for Drug Evaluation and Research (CDER) is working to update its biotech inspection compliance program to make better use of the process, product, and compliance information it has collected from the industry in the decade since the previous version went into effect and better target its inspection efforts....
- [IPEC Seeks to Improve Excipient Maker/User Communications on Visible Particles](https://ipq.org/ipec-seeks-to-narrow-excipient-makeruser-communication-gap-on-visible-particles/) - The International Pharmaceutical Excipients Council of the Americas (IPEC-Americas) is spearheading an effort to strengthen the communication pathway between excipient makers and users about the significance of benign visible particles in excipients....
- [FDA’s New Office of Program and Regulatory Operations Will Assume Pivotal Role in CMC Review](https://ipq.org/fdas-new-office-of-program-and-regulatory-operations-will-assume-pivotal-role-in-cmc-review/) - FDA’s Office of Program and Regulatory Operations (OPRO) – part of the new Office of Pharmaceutical Quality (OPQ) at the Center for Drug Evaluation and Research (CDER) – will be responsible for co-leading and facilitating the review of the quality portions of new and abbreviated new drug applications (NDAs/ANDAs)....
- [Implementation Challenges for ICH’s New M7 Guideline on Mutagenic Impurities Will Present Themselves at Both the Development and Post-Approval Levels](https://ipq.org/implementation-challenges-for-ichs-new-m7-guideline-on-mutagenic-impurities-will-present-themselves-at-both-the-development-and-post-approval-levels/) - Among the challenges that will present themselves to pharma companies in implementing ICH’s new M7 guideline on mutagenic impurities is the use of quantitative structure-activity relationship [QSAR] predictions in assessing the risks during development and for post-marketing changes....
- [Team-Based Quality Assessment Approach Among Key Changes Underway as CDER’s Office of Pharmaceutical Quality Comes to Life](https://ipq.org/team-based-quality-assessment-approach-among-key-changes-underway-as-cders-office-of-pharmaceutical-quality-comes-to-life/) - FDA’s Center for Drug Evaluation and Research (CDER) is finding that its new “team-based integrated quality assessment” model makes the review process more efficient and effective, and the model is winning the praise of team members involved....
- [CDER’s Office of Pharmaceutical Quality Will Become Functional in January Following Commissioner’s Call for Commodity-Oriented Center/Field Alignment](https://ipq.org/cders-office-of-pharmaceutical-quality-will-become-functional-in-january-following-commissioners-call-for-commodity-oriented-centerfield-alignment/) - The initiatives underway at FDA’s Center for Drug Evaluation and Research (CDER) that its new Office of Pharmaceutical Quality (OPQ) will help drive include expertise-based team reviews, closer review/inspection alignment, an auditable quality management system (QMS), a comprehensive pharmaceutical quality IT platform, and new preapproval and surveillance inspection approaches....
- [Transparent Discussions, Long-term Relationships and Global Event Monitoring Mark Amgen’s Supply Oversight Program](https://ipq.org/transparent-discussions-long-term-relationships-and-global-event-monitoring-mark-amgens-supply-oversight-program/) - Detailed, transparent technical discussions with suppliers, long-term supplier relationships, and a wide-ranging event monitoring system are three prongs in Amgen’s intensive effort to avoid supply disruptions and improve quality assurance....
- [Amgen “Analytics of the Future” Initiative Develops MS-based “Multi-Attribute Methodology” to Streamline Biotech Development and QC Testing](https://ipq.org/amgen-analytics-of-the-future-initiative-develops-ms-based-multi-attribute-methodology-to-streamline-biotech-development-and-qc-testing/) - Amgen is among the major biotech companies working hard on empowering, while at the same time streamlining, their analytical toolbox at the development and quality control testing levels as the next frontier of quality by design....
- [ICH Q3D Could Provide Model for More Inclusive ICH Process; Focus Continues on Q3D Implementation Challenges, Including Risk Assessments](https://ipq.org/ich-q3d-could-provide-model-for-more-inclusive-ich-process-focus-continues-on-q3d-implementation-challenges-including-risk-assessments/) - The development and implementation of the ICH Q3D guideline on elemental impurities could provide a model for a more inclusive ICH process....
- [CDER’s Office of Surveillance Will Oversee Expanding FDA’s QA Assessment Capabilities and Reshaping Inspections](https://ipq.org/cders-office-of-surveillance-will-oversee-expanding-fdas-qa-assessment-capabilities-and-reshaping-inspections/) - The analysis that FDA’s Center for Drug Evaluation and Research (CDER) is conducting to lay the foundation for a more comprehensive assessment of a manufacturer’s quality assurance (QA) capabilities is showing that the results of one inspection are not a reliable predictor of the outcome of a subsequent inspection at the same facility....
- [Pharmacopeial Modernization and Harmonization Efforts Spurred by Global Supply Chain Regulatory Needs; China’s Pharmacopeia Among Asian Participants](https://ipq.org/pharmacopeial-modernization-and-harmonization-efforts-spurred-by-global-supply-chain-regulatory-needs-chinas-pharmacopeia-among-asian-participants/) - The risks to product quality in an increasingly globalized supply chain – a prime driver of the CMC and GMP agendas of regulatory agencies – are also pushing pharmacopeias around the world to speed up their efforts to harmonize and modernize the compendial standards that support these regulatory processes....
- [FDA Cautioning Industry on Looming Initial Track and Trace Deadlines](https://ipq.org/9867/) - FDA is cautioning industry stakeholders that the initial implementation phase for the track and trace provisions in the Drug Quality and Safety Act (DQSA) is rapidly approaching, with interoperable product transaction requirements for manufacturers, distributors, and repackagers kicking in on January 1, 2015....
- [APEC’s Assessment of Gaps in Supply Chain Regulation Reveals Surprising Differences in Country Approaches](https://ipq.org/apecs-assessment-of-gaps-in-supply-chain-regulation-reveals-surprising-differences-in-country-approaches/) - The assessment by the Asia Pacific Economic Cooperation (APEC) organization of the gaps in the ability of regulatory agencies to address the problems of an international supply chain has revealed some surprising differences in their practices....
- [FDA Will Support Efforts to Upgrade Micro Methods and Processes, CDER Reviewer Affirms](https://ipq.org/fda-will-support-efforts-to-upgrade-micro-methods-and-processes-cder-reviewer-affirms/) - FDA Center for Drug Evaluation and Research (CDER) microbiology reviewers are assuring companies that they will be supportive of efforts to upgrade lab methods and manufacturing processes to take advantage of post-approval scientific advancements....
- [Top Deficiencies Found in CDER’s Micro Review of Regulatory Submissions Include Incomplete Information on Validation of Aseptic and Terminal Processes](https://ipq.org/top-deficiencies-found-in-cders-micro-review-of-regulatory-submissions-include-incomplete-information-on-validation-of-aseptic-and-terminal-sterilization-processes/) - Incomplete media fill information for aseptic processes and an inadequate comparison between production and validation conditions for terminal sterilization are among the microbiology concerns in regulatory submissions that most frequently generate information requests and deficiency letters from FDA’s Center for Drug Evaluation and Research (CDER)....
- [IPEC and IQ Consortium Team Up to Push for an Independent Pathway for New Excipient Review](https://ipq.org/ipec-and-iq-consortium-team-up-to-push-for-excipient-approval-pathway/) - A call to action is reverberating through the pharmaceutical community for the establishment of a viable regulatory pathway for new or modified excipients, which would empower industry to develop more quality-by-design-based formulations....
- [Progress of FDA’s Compliance/Enforcement Data Transparency Initiative Will Be Spurred by Refined Road Map from Working Groups](https://ipq.org/progress-of-fdas-complianceenforcement-data-transparency-initiative-will-be-spurred-by-refined-road-map-from-working-groups/) - The impact of FDA’s compliance/enforcement data “transparency initiative” will continue to increase with the help of a road map released by the initiative’s working groups in late April....
- [Success of Eight-Year Amgen Effort to Improve Deviation Investigations and Follow-up Actions Writ Large on Quality Metrics and Bottom Line](https://ipq.org/success-of-eight-year-amgen-effort-to-improve-deviation-investigations-and-follow-up-actions-writ-large-on-quality-metrics-and-bottom-line/) - The results of an eight-year program at Amgen to improve its deviation investigations and follow-up actions demonstrate how concentrating on finding and addressing root causes can have a substantial impact on a firm’s quality assurance and bottom-line....
- [FDASIA Heightens Focus on Proactive Communications with FDA; Timeliness, Accuracy and Transparency are Key, GMP Compliance Experts Advise](https://ipq.org/fdasia-heightens-focus-on-proactive-communications-with-fda-timeliness-accuracy-and-transparency-are-key-gmp-compliance-experts-advise/) - The provisions in the FDA Safety and Innovation Act (FDASIA) for communicating with FDA about manufacturing issues that could play out in drug shortages or facilitate regulatory surveillance are heightening industry’s focus on the agency’s expectations for proactive communications....
- [FDA Deploys Risk Ranking Process to Streamline ANDA Review](https://ipq.org/ogds-deploys-risk-ranking-process-to-streamline-anda-review/) - FDA’s generics office has developed a risk assessment algorithm for the review of abbreviated new drug applications (ANDAs) to help address the challenges of balancing more extensive quality-by-design-based submissions with the foreshortened review timelines mandated under the Generic Drug User Fee Act (GDUFA)....
- [Top Excipient DMF Problem Areas for FDA Include Authorization Letters, Paper Filings, and Annual Reports](https://ipq.org/top-excipient-dmf-problem-areas-for-fda-include-authorization-letters-paper-filings-and-annual-reports/) - FDA wants the excipient industry to better understand the challenges that the agency faces in reviewing drug master files (DMFs) and to improve their filings so that they do not impede the drug application process....
- [China’s FDA Voices Interest in Developing an Excipient DMF System at Meeting with IPEC China; India Among Countries Reviewing Excipient Regulatory Upgrades](https://ipq.org/chinas-fda-voices-interest-in-developing-an-excipient-dmf-system-at-meeting-with-ipec-china-india-and-brazil-among-countries-reviewing-excipient-regulatory-upgrades/) - China is among countries giving consideration to establishing a drug master file (DMF) system for excipients, as regulators world-wide seek to rationalize and improve their approaches to excipient oversight....
- [UK MHRA's Compliance Management Upgrade Includes "Risk Intelligence IT System" for Drug Inspection Targeting](https://ipq.org/u-ks-mhra-risk-intelligence-it-system-hones-inspection-scheduling-process-complementary-efforts-aimed-at-improving-compliance-communications-with-industry/) - U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) is creating a comprehensive “Risk Intelligence IT System” for determining where to deploy its inspection resources that captures and analyzes a wide variety of inputs from industry, public, and agency information sources....
- [Warning Letters from 2012 – Q1 2014 Show FDA’s GMP Enforcement Focus Shifting Overseas; Foreign Labs Draw Particular Attention](https://ipq.org/warning-letters-from-2012-q1-2014-show-fdas-gmp-enforcement-focus-shifting-overseas-foreign-labs-draw-particular-attention/) - An analysis of FDA drug GMP warning letters issued since the beginning of 2012 highlights the agency’s increasing focus on enforcement outside the US – and on laboratory practices at foreign facilities, in particular....
- [FDA Data Integrity Findings Continue at Indian Firms, Highlighting Challenges in Changing a Facility’s Quality Culture](https://ipq.org/fda-data-integrity-findings-continue-at-indian-firms-highlighting-challenges-in-changing-a-facilitys-quality-culture/) - FDA investigators are continuing to uncover serious data integrity issues at facilities in India, including repeat citations – highlighting the challenges regulators face in getting companies to make changes in their quality culture....
- [Component Testing Gains Prominence in Drug Product GMP Warning Letters as FDA Focus Intensifies on OTC Topicals and Upstream Supply Chain](https://ipq.org/component-testing-gains-prominence-in-2012-2014-drug-product-gmp-warning-letters-as-fda-focus-intensifies-on-otc-topicals-and-upstream-supply-chain/) - Inadequate testing of incoming components is a leading problem area being cited by FDA on finished drug product GMP warning letters and is particularly prevalent in the expanding number of those addressing compliance at topical manufacturers worldwide....
- [Wave of FDA Warning Letters to Injectable Compounders in Q1 2014 Follows 2013 Inspection Blitz and Legislative Empowerment; Recipients Among Those Applying for Outsourcing Status](https://ipq.org/wave-of-fda-warning-letters-to-injectable-compounders-in-q1-2014-follows-2013-inspection-blitz-and-legislative-empowerment-recipients-among-those-applying-for-outsourcing-status/) - A bolus of FDA warning letters to injectable compounding operations in the first quarter of 2014 has followed in the wake of the agency’s 2013 inspection blitz of high-volume sterile pharmacy compounding operations nationwide and legislative empowerment through the Drug Quality and Safety Act (DQSA), signed into law in November....
- [Comments on FDA’s Draft Compounding Guidances Reflect Complex Factors and Varied Stakeholders Involved](https://ipq.org/comments-on-fdas-draft-compounding-guidances-reflect-complex-factors-and-varied-stakeholders-involved/) - Draft guidances and Federal Register (FR) notices issued by FDA in December to help implement the compounding provisions in the Drug Quality and Safety Act (DQSA) drew a wide array of comments that reflect the complexity of the factors that need to be considered in advancing the regulatory processes for compounding....
- [Compounding Drivers and Problems Dissected by Merck Pharmacy Expert at April PDA Annual Meeting](https://ipq.org/compounding-drivers-and-problems-dissected-by-merck-pharmacy-expert-at-april-pda-annual-meeting/) - Root causes of the problems in the pharmacy compounding arena range from the absence of training in pharmacy schools to commercial pressures that prompt established pharmaceutical firms to leave the market and force hospitals to rely on less qualified providers to fill their immediate patient needs, Merck Engineering BioSterile Validation Director Chris Smalley commented at the April PDA annual meeting held in San Antonio, Texas....
- [ICH Q8-11 Oriented Submission and GMP Expectations for Process Validation and Other Quality Issues Taking Shape in Europe](https://ipq.org/ich-q8-11-oriented-submission-and-gmp-expectations-for-process-validation-and-other-quality-issues-taking-shape-in-europe/) - The effort in Europe to update its expectations for process validation (PV) to reflect the quality management principles underpinning ICH Q8-11 moved closer to completion in late February with the issuance of a final guideline on PV submissions for medicinal products and a draft revision of EU GMP Annex 15....
- [International Panel of Regulators Spotlights Current Biotech CMC Regulatory Problems and Convergence Pathways](https://ipq.org/global-regulator-panel-spotlights-current-biotech-cmc-regulatory-problems-and-convergence-pathways-forward/) - The limitations, constraints and disconnects in the current CMC regulatory processes around the world are emerging into high relief as the biopharmaceutical community wrestles with how to get new medicines that fill critical healthcare gaps more rapidly to patients and how to facilitate manufacturing adjustments that better assure the quality of marketed products....
- [Global Quality Regulatory Maze Jeopardizes Vaccine Supply, IFPMA is Stressing](https://ipq.org/global-quality-regulatory-maze-jeopardizes-vaccine-supply-ifpma-is-stressing/) - The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) is throwing a spotlight on the impact that the current tangled global regulatory web is having on the ability to supply vaccines to the people who need them....
- [Post-Approval Change Regulatory Burden Draws Heat at Japan Biotech CMC Strategy Forum](https://ipq.org/post-approval-change-regulatory-burden-draws-heat-at-japan-cmc-strategy-forum/) - Industry associations have been meeting with Japanese regulators to highlight the problems they are experiencing in Japan’s process for regulating post-approval manufacturing changes, including a lack of flexibility around biotech product changes that results in most requiring prior approval as well as meetings with the agency to resolve unclear expectations....
- [Top Analytical Method Problems in INDs and BLAs Include Not Enough Detail for FDA Replication and Inadequate Suitability Controls](https://ipq.org/top-analytical-method-problems-in-inds-and-blas-include-not-enough-detail-for-fda-replication-and-inadequate-suitability-control/) - Insufficient detail to allow FDA to replicate an analytical method, and failure to include appropriate system suitability controls, are two prominent analytical method problem areas that FDA is finding in reviewing investigational new drug (IND) and biologic license application (BLA) submissions....
- [CDER Compliance Office Quality Regulatory Priorities for 2014 Include Implementing DQSA, FDASIA and Reorganization Plans](https://ipq.org/cder-compliance-office-quality-regulatory-priorities-for-2014-include-implementing-dqsa-fdasia-and-reorganization-plans/) - The top priorities at FDA’s Center for Drug Evaluation and Research (CDER) compliance office in 2014 will include implementing the compounding (Title I) and track and trace (Title II) provisions of the Drug Quality and Security Act (DQSA), signed into law in late 2013, along with the ongoing implementation efforts on the generic drug user fee (Title I), supply chain (Title VII) and drug shortage (Title X) facets of the 2012 FDA Safety and Innovation Act (FDASIA)....
- [Biotherapeutics Developers Are Wrestling with Challenges of Connecting Quality Attributes to Immunogenicity](https://ipq.org/biotherapeutics-developers-are-wrestling-with-challenges-of-connecting-quality-attributes-to-immunogenicity/) - The developers of biotherapeutics are intensifying their efforts to understand the complex relationships between the structure of their molecules and immunogenicity and to expand the predictive power of their CMC toolbox. However, there is also a growing recognition of the long-term nature of the project and the difficulties in validating the quality analytical tools against the less than solid ground of immunogenicity assessments in the clinic....
- [FDA Moves Quickly to Implement Compounding Provisions of Drug Quality and Security Act](https://ipq.org/fda-moves-quickly-to-implement-compounding-provisions-of-drug-quality-and-security-act/) - FDA is moving quickly to give regulatory flesh to the compounding provisions of the new Drug Quality and Security Act of 2013 (DQSA), signed into law by President Obama on November 27....
- [A Well-Thought-Out Immunogenicity Clinical Evaluation is Needed to Overcome Prediction Limitations for MAbs, NIBSC Expert Cautions](https://ipq.org/a-well-thought-out-immunogenicity-clinical-evaluation-is-needed-to-overcome-prediction-limitations-for-mabs-nibsc-expert-cautions/) - A well-thought-out clinical evaluation of the immunogenicity of monoclonal antibodies is a critical component of the regulatory clearance pathway and making predictions and generalizations short of this clinical analysis is dangerous, UK’s National Institute for Biological Standards and Control Biotherapeutics Group Head Robin Thorpe cautioned the attendees at a PDA MAb workshop in Basel, Switzerland in September....
- [Industry is Exploring How to Empower Pharmacovigilance Programs to Find GMP Root Causes](https://ipq.org/industry-is-exploring-how-to-empower-pharmacovigilance-programs-to-find-gmp-root-causes/) - Building a system capable of finding quality problems through a firm’s pharmacovigilance program must begin early in development, one of the leading experts in the field, Lilly Global Patient Safety Senior Director John Ayres, is advising industry....
- [Interactions Between OGD’s Inactive Ingredients Database Working Group and IPEC on IID Content and Functionality Bearing Fruit](https://ipq.org/interactions-between-ogds-inactive-ingredients-database-working-group-and-ipec-on-iid-content-and-functionality-bearing-fruit/) - The cooperative effort between FDA’s Inactive Ingredients Database (IID) Working Group and the International Pharmaceutical Excipients Council (IPEC) to improve the IID’s content and functionality is beginning to bear fruit and will gain further momentum from the extra resources that will become available to the Office of Generic Drugs (OGD) to support projects that meet the Generic Drug User Fee Act (GDUFA) goals of creating a more efficient review process....
- [Transformation in Industry Practice Must Accompany FDA’s Generics Program Overhaul to Meet GDUFA Goals, OGD Stresses](https://ipq.org/transformation-in-industry-practice-must-accompany-fdas-generics-program-overhaul-to-meet-gdufa-goals-ogd-stresses/) - A core message emerging from the presentations by FDA management at the GPhA/FDA Fall Technical Conference in Bethesda, MD in late October is that the transformation underway in the agency’s generic drug review program will need to be matched by an equivalent transformation in industry practice for the goals of the Generic Drug User Fee Act (GDUFA) to be achieved....
- [Level of Industry Response to FDA’s Quality Agreement Draft Guidance Reflects Contracting Challenges; Terminology at Issue](https://ipq.org/level-of-industry-response-to-fdas-quality-agreement-draft-guidance-reflects-contracting-challenges-terminology-at-issue/) - The raft of industry comments FDA has received on its draft guidance on “Quality Agreements for Contract Manufacturing Arrangements for Drugs” underscores the importance of having clear terminology when addressing the complexities in the contracting arena....
- [Successful Tech Transfer to a CMO Depends on a Strong Quality Agreement and Open Communication Pathways, FDA Asserts](https://ipq.org/successful-tech-transfer-to-a-cmo-depends-on-a-strong-quality-agreement-and-open-communication-pathways-fda-asserts/) - A detailed description of how a drug product owner will transfer technical knowledge to a contract manufacturer needs to be part of a quality agreement, FDA officials are stressing....
- [Joint Drafting of Contract Manufacturing Quality Agreements Needed to Reflect Shared Quality Ownership, FDA Stresses](https://ipq.org/joint-drafting-of-quality-agreements-needed-to-reflect-shared-quality-ownership-fda-stresses/) - FDA is stressing that quality agreements between product owners and the contract manufacturing organizations (CMOs) they work with should be drafted jointly by both parties and reflect the depth of understanding each has regarding their roles and responsibilities in the intimate relationship they share....
- [Comment Process on FDA’s Proposed Rule on Product Detention During Inspections Reflects Industry Support](https://ipq.org/comment-process-on-fdas-proposed-rule-on-product-detention-during-inspections-reflects-industry-support/) - The comment process on FDA’s proposed rule on “Administrative Detention of Drugs Intended for Human Animal Use” as authorized under Title VII of the FDA Safety and Innovation Act (FDASIA) has indicated industry’s comfort level with extending the detention authority the agency already had for foods and devices to drug products....
- [Vetting of ICH Q3D Pre-Step 2 Impacts Final Draft; LVP and E&L Issues Could Warrant Further Public Comment](https://ipq.org/vetting-of-ich-q3d-pre-step-2-draft-impacts-final-version-lvp-and-el-issues-could-warrant-further-public-comment/) - Large volume parenterals (LVPs) and extractables and leachables (E&Ls) from container closure systems were two issues on which the ICH Q3D Expert Working Group (EWG) requested input from stakeholders during the Step 2 drafting process without getting much feedback, and may warrant attention during the draft’s public comment phase that runs through December, EWG members are advising....
- [IPEC and a Broader Coalition of Industry Associations Identify ICH Q3D Implementation Challenges and What is Needed to Meet Them](https://ipq.org/ipec-and-a-broader-coalition-of-industry-associations-identify-ich-q3d-implementation-challenges-and-what-is-needed-to-meet-them/) - The International Pharmaceutical Excipients Council (IPEC) and the Coalition for Rational Implementation of the USP Elemental Impurities Requirements, of which IPEC is a member, have been taking a hard look at where the key challenges lie in implementing the elemental impurity standards in the new Step 2b draft of ICH Q3D and what tools they can provide to assist the pharmaceutical regulatory community in addressing them....
- [CBER Focus Intensifying on Export Certification, Adverse Event Databases, and Lab Help in Product Development](https://ipq.org/cber-focus-intensifying-on-export-certification-adverse-event-databases-and-lab-help-in-product-development/) - Initiatives that will be on the front burner at the Center for Biologics Evaluation and Research (CBER) over the next year include: ● the completion of an electronic export certification system ● the increased use of databases to identify and confirm adverse events with vaccines and blood products, and ● using its extensive laboratory facilities and expertise to help in the development of novel products....
- [FDASIA Section 707 Draft Guidance on Obstructing Inspections Draws Industry Comments; Investigator Subjectivity Among Issues Raised](https://ipq.org/fdasia-section-707-draft-guidance-on-obstructing-inspections-draws-industry-comments-investigator-subjectivity-among-issues-raised/) - FDA’s new draft guidance on “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection” has drawn some industry concern regarding the degree of subjectivity it affords investigators in determining when the lines have been crossed....
- [Industry Asks FDA to Clarify How Current CMC Submission Paradigm Can Flex to Accommodate Breakthrough Therapy Development Timelines](https://ipq.org/industry-asks-fda-to-clarify-how-current-cmc-submission-paradigm-can-flex-to-accommodate-breakthrough-therapy-development-timelines/) - Industry is looking for more clarity from FDA on those aspects of the CMC program that can be completed either during application review or post-approval to allow the expedited clearance goals for breakthrough therapies to be realized....
- [EDQM Amends CEP Submission and Revision Process; Starting Materials Remain at Issue; Risk-Based CEP Inspection Approach is Finding Problems](https://ipq.org/edqm-amends-cep-submission-and-revision-process-starting-materials-remain-at-issue-risk-based-cep-inspection-approach-is-finding-problems/) - A revised process for amending or renewing certificates of suitability (CEPs) put in place by the European Directorate for the Quality of Medicines and Healthcare (EDQM) mandates that some major changes previously filed as revisions will now require applying for a new CEP. The revised process went into effect on September 1....
- [Compressed Breakthrough Therapy Timelines Require Intensified Upfront Sponsor Dialogue on CMC Plans Internally, With Contractors and With FDA](https://ipq.org/compressed-breakthrough-therapy-timelines-require-intensified-upfront-sponsor-dialogue-on-cmc-plans-internally-with-contractors-and-with-fda/) - FDA is stressing that the ability to meet the aggressive expedited review goals of the breakthrough therapy pathway will hinge on the sponsor intensifying its upfront CMC coordination and communication internally, with outside contractors involved with drug substance and product manufacturing, testing and packaging, and with the agency....
- [Industry Weighs in on FDASIA Title VII Importation Provisions; Participants Sought for Secure Supply Chain Pilot](https://ipq.org/industry-weighs-in-on-fdasia-title-vii-importation-provisions-participants-sought-for-secure-supply-chain-pilot/) - Confirming a manufacturer’s state of compliance in advance of its product entering the US, and establishing a risk-based tiered system with correspondingly different documentation requirements for each tier, are among the suggestions the pharma industry is making to FDA regarding the implementation of the importation provisions in Title VII of the FDA Safety and Innovation Act (FDASIA)....
- [FDA Data Integrity Concerns Continue in India as Three More Firms Draw GMP Warning Letters](https://ipq.org/fda-data-integrity-concerns-continue-in-india-as-three-more-firms-draw-gmp-warning-letters/) - Three warning letters recently issued on findings at facilities in India indicate FDA’s continued focus on data integrity as a central concern of its international inspection program – and in the Indian arena, in particular....
- [NSF-IPEC 363 GMP Standard Will Provide Risk-Based Approach for Auditing and Certifying Excipient Manufacturers](https://ipq.org/nsf-ipec-363-gmp-standard-will-provide-risk-based-approach-for-auditing-and-certifying-excipient-manufacturers/) - NSF International is working with the International Pharmaceutical Excipients Council (IPEC) and FDA to turn the IPEC excipient GMPs into a risk-based, certifiable standard with global applicability by the end of 2013, as recognition of the importance of excipient control continues to grow....
- [Revision of EU Annex 16 Clarifies QP Responsibilities in the Face of an Increasingly Complex Supply Chain](https://ipq.org/revision-of-eu-annex-16-clarifies-qp-responsibilities-in-an-increasingly-complex-supply-chain/) - A clear distinction between the release of a batch and its certification by the Qualified Person (QP), directions for what responsibilities the QP can share and how, and a template for use by a QP to sign off on a subset of manufacturing steps are among the significant changes EMA has incorporated into a revision of its Annex 16, which was released for public comment in early July....
- [FMD Implementation in Europe Drives Better API Sourcing Knowledge and Interagency Communications](https://ipq.org/fmd-implementation-drives-better-api-sourcing-knowledge-and-interagency-communications/) - Implementation of Europe’s Falsified Medicines Directive (FMD) has shed important light on what the active pharmaceutical ingredient (API) part of the global pharmaceutical supply chain actually looks like and has led to enhanced communication between the countries that participate in it....
- [FDA Piloting Electronic FARs as Focus Intensifies on Defect Data Mining](https://ipq.org/fda-piloting-electronic-fars-as-focus-intensifies-on-defect-data-mining-2/) - FDA is piloting an electronic Field Alert Report (FAR) system that could help foster improved defect detection, prevention, and mitigation, and further empower the agency’s ability to understand where the industry shortfalls are and the particular firms that need heightened enforcement attention....
- [Analyses of Defect Reports by Ireland’s IMB and FDA Highlight Packaging and Labeling as Key Pharma Manufacturing Problem Area](https://ipq.org/analyses-of-defect-reports-by-irelands-imb-and-fda-highlight-packaging-and-labeling-as-key-pharma-manufacturing-problem-area/) - Analyses by the Irish Medicines Board (IMB) and FDA of their data on deviation reporting over the past few years indicate the prominence of packaging and labeling as a problem area in the pharmaceutical manufacturing arena....
- [FDA is Working to Expand Question-Based Review Approach From Generic to Innovator Applications](https://ipq.org/fda-is-working-to-expand-question-based-review-approach-from-generic-to-innovator-applications/) - A working group that spans the new drug and generic reviewing offices at FDA’s Center for Drug Evaluation and Research (CDER) is nearing release of a proposed revision of the questions it developed under its question-based review (QbR) approach for generics that is designed to be applied to innovator applications as well....
- [Pharmacy Compounding Legislation Introduced in Both Houses of Congress Provides for FDA Regulatory Flexibility and Inspection Authority](https://ipq.org/pharmacy-compounding-legislation-introduced-in-both-houses-of-congress-provides-for-fda-regulatory-flexibility-and-inspection-authority/) - Legislation has been introduced in both houses of Congress that would provide FDA with the power and flexibility it needs to define the regulatory requirements for high-risk compounding operations and the authority to inspect those that engage in interstate commerce....
- [APEC Supply Chain Regulatory Harmonization Effort Gaining Traction](https://ipq.org/apec-supply-chain-regulatory-harmonization-effort-gaining-traction/) - The Asia Pacific Economic Cooperation (APEC) organization is developing and implementing a five-year plan cutting across GMPs, GDPs, pharmacy practices and Internet sales that could have a powerful influence on global regulatory harmonization in the pharmaceutical supply chain arena....
- [Compounder Recalls, 483s and Warning Letters Continue in Wake of FDA Inspection Blitz](https://ipq.org/compounder-recalls-483s-and-warning-letters-continue-in-wake-of-fda-inspection-blitz/) - The wave of recalls of contaminated preparations and FDA-483s is continuing as FDA’s extensive inspection blitz of compounding pharmacies across the US hits the four-month mark....
- [The Sterility Risks in Pharmacy Compounding Can Be Limited, Not Eliminated, Experts Stress at USP Forum](https://ipq.org/the-sterility-risks-in-pharmacy-compounding-can-be-limited-not-eliminated-experts-stress-at-usp-forum/) - The sterility control challenges that pharmacy compounding presents stretch from practitioners trying to handle continually changing procedures and preparations, to the laboratories trying to do quality control testing in the context of these shifting targets and sample constraints, to the array of distribution and storage avenues – and limiting the risks rather than eliminating them should be the goal, participants at a US Pharmacopeia (USP) forum agreed....
- [FDASIA Title VII Implementation Priorities and Action Plans Taking Shape](https://ipq.org/fdasia-title-vii-implementation-priorities-and-action-plans-taking-shape/) - FDA has been sorting through the multi-faceted supply chain provisions of Title VII of the FDA Safety and Innovation Act (FDASIA) to identify which should be tackled first and to put action plans in place to implement them....
- [Pharmacy Compounding Will Remain Center Stage as FDA’s Focus Intensifies on Drug Quality, Hamburg Tells FDLI](https://ipq.org/pharmacy-compounding-will-remain-center-stage-as-fdas-focus-intensifies-on-drug-quality-hamburg-tells-fdli/) - Pharmacy compounding will remain center stage as FDA’s focus on drug quality continues to intensify, FDA Commissioner Margaret Hamburg told attendees at the 2013 Food and Drug Law Institute (FDLI) Annual Conference in late April in Washington, D.C....
- [FDASIA Implementation and a Sharpened Focus on Quality Head Center for Drugs’ Agenda](https://ipq.org/fdasia-implementation-and-a-sharpened-focus-on-quality-dominating-center-for-drugs-agenda/) - The impact of the Food and Drug Administration Safety and Innovation Act (FDASIA) on the Center for Drug Evaluation and Research (CDER) is beginning to be felt as the center comes to grips with implementing the requirements of the Act and the organizational effort it will take to meet them....
- [FDA Draft Guidance on Quality Agreements for Drug Contract Manufacturing Nears Release](https://ipq.org/fda-draft-guidance-on-quality-agreements-for-drug-contract-manufacturing-nears-release/) - An FDA cross-center working group has developed a draft guidance on quality agreements for drug contract manufacturing that is undergoing the final stages of FDA internal review and is expected to be released for public comment this summer....
- [Contaminated Injectables Recalled by Another Two Compounders; Avastin Again Involved](https://ipq.org/contaminated-injectables-recalled-by-another-two-compounders-avastin-again-involved/) - Recalls of aseptic products due to sterility concerns produced by compounding pharmacies in Georgia and New Jersey represent the latest in a string of quality problems found at compounders across the country. Clinical Specialties of Martinez, Ga., is recalling all of its sterile products, including 40 lots of Avastin distributed to doctors’ offices in Georgia,
- [The Accelerated Recovery Initiative on Drug Shortages is Gaining Momentum – Pilot Program Underway](https://ipq.org/the-accelerated-recovery-initiative-on-drug-shortages-is-gaining-momentum-pilot-program-underway/) - The Accelerated Recovery Initiative (ARI) – an FDA/industry partnership being coordinated by pharma data manager IMS – is gaining momentum in its effort to forecast, prevent, and mitigate the impact of drug shortages, and a pilot program is now underway....
- [FDA and EU Inspectors Draw Insight at Contract Manufacturers Into GMP Enforcement/Drug Shortage Crosscurrents](https://ipq.org/fda-and-eu-inspectors-gaining-insight-at-contract-manufacturers-into-gmp-enforcementdrug-shortage-complications/) - U.S. and European health agency inspectors are gaining more insights during their inspections of contract manufacturers into the complexities of balancing GMP enforcement with drug shortage prevention....
- [FDA Inspection Blitz Reveals Weakness in Sterile Practices at Large Compounders](https://ipq.org/fda-inspection-blitz-reveals-weakness-in-sterile-practices-at-large-compounders/) - A review of the initial results from an inspection blitz of about 30 high-volume sterile pharmacy compounding operations nationwide launched by FDA in late February shows a clear pattern of weakness in their sterile practices including environmental monitoring, gowning, personnel practices and sterility/endotoxin testing....
- [Letter from CDER’s Woodcock to PharMEDium Serves as Notice to Compounders and Hospitals on Need for Product/Patient Linkage](https://ipq.org/letter-from-cders-woodcock-to-pharmedium-serves-as-notice-to-compounders-and-hospitals-on-need-for-productpatient-linkage/) - An early February letter from CDER Director Janet Woodcock to hospital infusion/admixture supplier PharMEDium Services puts compounders and the hospitals they serve on notice that the agency will expect compounded preparations to be linkable to the specific patient using them....
- [Debate Continues Among Stakeholders on Framework for Regulating Pharmacy Compounding; Legislative Options Reviewed at FDLI Forum](https://ipq.org/debate-continues-among-stakeholders-on-framework-for-regulating-pharmacy-compounding-legislative-options-reviewed-at-fdli-forum/) - Congress, FDA, and the states, together with a wide mix of other stakeholders, are wrestling with how to define a more viable and coherent model for regulating pharmacy compounding – where the boundaries should be placed between state and federal oversight and what the respective regulatory structures and rules should look like....
- [Iowa, Massachusetts, California and Virginia Intensify Compounding Pharmacy Crackdown](https://ipq.org/iowa-massachusetts-california-and-virginia-intensify-compounding-pharmacy-crackdown/) - The crackdown on pharmacy compounding in the wake of the fungal meningitis crisis continues to intensify as states such as Iowa, Massachusetts, California and Virginia pursue a combination of tougher licensing requirements, more frequent inspections, aggressive enforcement, and a better understanding of the operations of compounders selling in their states....
- [EC Releases Outcome of Late-2011 Variations Consultation](https://ipq.org/ec-releases-outcome-of-late-2011-variations-consultation/) - The European Commission (EC) has released the outcome of the proposed changes to its variations rules in early February. The proposed changes as described “were not considered sufficiently clear and clarification has been requested” by the 40 stakeholders, the EC summarized. The commission notes that the contributions received were “extensive and detailed,” adding that the
- [FDA and ISPE Seek Stakeholder Input to Improve Drug Shortage Prevention and Mitigation Strategies](https://ipq.org/fda-and-ispe-seek-stakeholder-input-to-improve-drug-shortage-prevention-and-mitigation-strategies/) - FDA and the International Society for Pharmaceutical Engineering (ISPE) are both surveying stakeholders in the pharmaceutical supply chain to help shed light on the causes of drug shortages and formulate better prevention and mitigation strategies....
- [QP Review of More Complex Supply Chains and Applications, EU Member State Differences, Among Issues Facing EMA in Annex 16 Revision](https://ipq.org/qp-review-of-more-complex-supply-chains-and-applications-eu-member-state-differences-among-issues-facing-ema-in-annex-16-revision/) - EMA’s GMP/GDP Inspectors Working Group (IWG) is wrestling with how to build into EU GMP Annex 16 the assurance that the Qualified Person (QP) understands the complexities of a globalized supply chain in certifying that a batch complies with GMP/GDP requirements and the new mandates of the Falsified Medicines Directive (FMD)....
- [EMA Guidelines on Process Validation Filings for Biotech Substances and Drug Products Advancing Along with GMP Annex 15 Revision](https://ipq.org/ema-guidelines-on-process-validation-filings-for-biotech-substances-and-drug-product-advancing-along-with-gmp-annex-15-revision/) - A guideline on what the European Medicines Agency (EMA) wants to see in marketing authorization applications (MAAs) regarding process validation for biotech drug substances is advancing as a third prong in the agency’s effort to strengthen its PV guidance portfolio....
- [CDER Officials Shed Light on Forces Impacting Generic Injectable GMP Compliance and Drug Shortages](https://ipq.org/cder-officials-shed-light-on-forces-impacting-generic-injectable-gmp-compliance-and-drug-shortages/) - FDA’s current engagement with the GMP compliance problems in the generic injectable arena illustrates the tightrope the agency is walking in trying to protect patients against substandard, high-risk products, while at the same time trying to assure that they have access to the critical medicines they need...
- [Ben Venue Consent Decree Traces History of Injectable GMP Noncompliance and Defines Remediation Pathway](https://ipq.org/ben-venue-consent-decree-traces-history-of-injectable-gmp-noncompliance-and-defines-remediation-pathway/) - FDA findings at Ben Venue’s Bedford, Ohio injectable manufacturing facility in 2011 that GMP problems cited in a 2007 warning letter had still not been corrected resulted in a consent decree, approved by the US District Court of Northern Ohio on January 31....
- [EMA GMP Chapter Draft Revisions Focus on Current Compliance Focal Points from Shared Facilities to Defect Investigations](https://ipq.org/ema-gmp-chapter-draft-revisions-focus-on-current-compliance-focal-points-from-shared-facilities-to-defect-investigations/) - The European Medicines Agency (EMA) has released draft revisions of four of its GMP chapters, intended to communicate its expectations regarding current compliance focal points including supply chain oversight, shared facilities, starting materials, lab method transfers, and investigating and reporting quality defects....
- [Revamped EudraGMP Database May Make GMP Noncompliance Statements Public](https://ipq.org/revamped-eudragmp-database-may-contain-publicly-available-gmp-noncompliance-statements/) - In the revamp of its EudraGMP database, the European Medicines Agency (EMA) is considering making GMP noncompliance statements publicly available....
- [Better Glycosylation Understanding Would Further International Biotech Regulatory Convergence Efforts, CMC Strategy Forum Participants Agree](https://ipq.org/better-glycosylation-understanding-would-further-international-biotech-regulatory-convergence-efforts-cmc-strategy-forum-participants-agree/) - Regulators are highlighting a better understanding of protein glycosylation – its linkage to product safety and efficacy and what constitutes appropriate characterization – as an important element in developing a more internationally-aligned approach to regulating biotech products....
- [ICH Vets Another Pre-Step 2 Q3D Draft to Strengthen Consensus on Heavy Metal Standards](https://ipq.org/ich-vets-another-pre-step-2-q3d-draft-to-strengthen-consensus-on-heavy-metal-standards/) - In mid-December, the ICH Q3D Expert Working Group (EWG) sent out a second, pre-Step 2 draft of its elemental impurities guideline to draw further input from constituent organizations on the challenging, broadly impactful issues it encompasses, with the target of achieving a draft that meets the Step 2 ICH consensus criteria by mid-2013....
- [Congressional Hearings Expand Meningitis/NECC Probe; More Light Shed on Regulatory Gaps](https://ipq.org/congressional-hearings-expand-meningitisnecc-probe-more-light-shed-on-regulatory-gaps/) - The Congressional investigation into the fungal meningitis outbreak caused by contaminated injectable methylprednisolone acetate (MPA) made and distributed by the New England Compounding Center (NECC) continued to expand in depth and breadth with a pair of hearings held in the House and Senate, respectively, in mid-November....
- [FDA Inspection Findings of Sterile Practice Breeches at Ameridose Mirror Those at NECC](https://ipq.org/fda-inspection-findings-of-sterile-practice-breeches-at-ameridose-mirror-those-at-necc/) - A resource-intensive investigation by FDA of Ameridose’s sterile manufacturing operations has found a markedly similar gap from acceptable practice to that agency investigators found at the New England Compounding Center (NECC) – the sister company to Ameridose responsible for the fungal meningitis outbreak....
- [FDASIA Title VII Empowers FDA in Supply Chain Arena; Congress Adds Other Tools to Help on Drug Shortages and Theft](https://ipq.org/fdasia-title-vii-empowers-fda-in-supply-chain-arena-congress-adds-other-tools-to-help-on-drug-shortages-and-theft/) - Title VII of the Food and Drug Administration Safety and Innovation Act (FDASIA) gives FDA additional tools it has been seeking to better confront the challenges of regulating a global supply chain....
- [ICH Q10’s Role as Guidepost on Pharma Journey from “Blind Compliance” to Operational Excellence Affirmed at PDA/FDA Workshop](https://ipq.org/ich-q10s-role-as-guidepost-on-pharma-journey-from-blind-compliance-to-operational-excellence-affirmed-at-pdafda-workshop/) - ICH Q10 is serving as an important guidepost on pharma’s journey from “blind compliance” to operational excellence, NSF-DBA Senior Partner Neil Wilkinson affirmed in his opening presentation at a PDA/FDA workshop in mid-September....
- [New FDA Field Alert Report System Provides for Electronic Submission and Unique Identifiers](https://ipq.org/new-fda-field-alert-report-system-provides-for-electronic-submission-and-unique-identifiers/) - FDA is upgrading its field alert report (FAR) system to provide for secure electronic submission of the reports, simultaneous transmittal to the appropriate district office and the Center for Drug Evaluation and Research (CDER), and unique identifiers for each report....
- [Supply Chains and Customer Service Need Prompt Shoring Up, Veteran Pharma Exec Warns](https://ipq.org/supply-chains-and-customer-service-need-prompt-shoring-up-veteran-pharma-exec-warns/) - A veteran pharma executive is sounding a warning call to industry that its current approach to supply chains, outsourcing and customer service needs to be overhauled quickly to address the disruptions causing drug shortages, advance operational excellence, and restore its reputation....
- [GPhA Weighs In On API and QbD Issues Needing Clarification for Generics; OGD Outlines Starting Material Expectations](https://ipq.org/gpha-weighs-in-on-api-and-qbd-issues-needing-clarification-for-generics-ogd-outlines-starting-material-expectations/) - The designation of drug substance starting materials and the information that will need to be provided on them in Drug Master Files are among the issues on which members of the Generic Pharmaceutical Association (GPhA) are asking for further clarification from FDA’s generics office as it moves forward in upgrading its review processes with the support of quality-by-design (QbD) principles and user fee resourcing....
- [New FDA ANDA Stability Guidance Will Embody ICH Standards; GPhA Supportive With Some Adjustments](https://ipq.org/new-fda-anda-stability-guidance-will-embody-ich-standards-gpha-supportive-with-some-adjustments/) - The Office of Generic Drugs will be issuing a new draft stability guideline that will more formally align the expectations for Abbreviated New Drug Applications (ANDAs) and Drug Master Files (DMFs) with ICH and a QbD-oriented regulatory paradigm....
- [GDUFA Expectations for Fee Payment and Facility Registration Out for Comment; Public Meeting Scheduled](https://ipq.org/gdufa-expectations-for-fee-payment-and-facility-registration-out-for-comment-public-meeting-scheduled/) - FDA has put on the table its expectations for complying with the Generic Drug User Fee Amendments (GDUFA) – including two draft guidances clarifying the payment of fees and registration of manufacturing facilities – and is asking for quick industry feedback as the beginning of the implementation process for GDUFA draws near....
- [Initiatives to Strengthen FDA's Generic Drug Review Process Include OGD Supplement and Peptide Teams](https://ipq.org/initiatives-to-strengthen-generic-drug-review-process-include-ogd-supplement-and-peptide-teams/) - FDA’s Office of Generic Drugs (OGD) has created dedicated teams for the review of supplements and peptide drugs as part of an office-wide effort to improve the efficiency and effectiveness of its review processes and explore where policy and resource improvements are needed....
- [Changes to OGD’s API DMF Process Target Submission Quality and Review Streamlining](https://ipq.org/changes-to-ogds-api-dmf-process-target-submission-quality-and-review-streamlining/) - Significant changes are being made by FDA’s Office of Generic Drugs (OGD) to its active ingredient Drug Master File (DMF) review program to improve the quality of industry submissions and streamline the review process so that DMFs are not a rate-limiting factor in ANDA clearance....
- [FDA’s Generics Office is Revising its QbR Questions to Sharpen Focus on QbD and Control Strategy](https://ipq.org/fdas-generics-office-is-revising-its-qbr-questions-to-sharpen-focus-on-qbd-and-control-strategy/) - FDA’s Office of Generic Drugs (OGD) is revising the questions underpinning its Question-based Review (QbR) approach to sharpen their focus on the quality-by-design (QbD) and control strategy information the office wants industry to provide in Abbreviated New Drug Applications (ANDAs)....
- [Biosimilar Developer May Gain Edge Over Originator on Structure/Function and Process/Product Knowledge, Sandoz Maintains](https://ipq.org/biosimilar-developer-may-gain-edge-over-originator-on-structurefunction-and-processproduct-knowledge-sandoz-maintains/) - Sandoz has been making the case in recent public presentations, publications and regulatory guidance comments that companies developing biosimilars may end up knowing more about structure/function and product/process relationships than the companies originating the products they are targeting....
- [Regulatory Pathways Are Opening Up Globally for Biosimilars](https://ipq.org/regulatory-pathways-are-opening-up-globally-for-biosimilars/) - Implementation of biosimilar legislation in India and Brazil, an increase in drug review staff in Japan, and the publication of a draft monograph for monoclonal antibodies to be included in the Chinese pharmacopeia are among the regulatory efforts taking place across the globe that expand the opportunities for biosimilars....
- [MedImmune’s Agreement to Produce Merck's Biosimilars Exemplifies Shifting Biotech Manufacturing Sands](https://ipq.org/medimmunes-agreement-with-merck-to-produce-its-biosimilars-exemplifies-shifting-biotech-sands/) - MedImmune’s long-term, “trusted partner” agreement with Merck to produce Merck's biosimilars exemplifies the shifting sands of biotech production capability and need and the different relationships that are being explored to handle that flux....
- [Raft of Comments on FDA Biosimilar Draft Guidances Draw Attention to Protein Definition, Interchangeability and Naming](https://ipq.org/raft-of-comments-on-fda-biosimilars-draft-guidances-draw-attention-to-protein-definition-interchangeability-and-naming/) - The definition of “protein,” the requirement for a “higher standard” for interchangeability, and the use of international nonproprietary names (INNs) for biosimilars were issues drawing particular attention from industry in commenting on FDA’s biosimilars draft guidances....
- [Glass Integrity Threats for Injectables Probed at Wholesale and Specialty Pharmacy Levels](https://ipq.org/glass-integrity-threats-for-injectables-probed-at-wholesale-and-specialty-pharmacy-levels/) - Pharmaceutical manufacturers are beginning to probe deeper into the glass integrity threats to injectable products occurring downstream at the wholesale and specialty pharmacy levels, beyond their traditional reach....
- [IQ Consortium Creates Foundation to Address Pharma Lab Data Disconnects as Momentum Builds in Second Year](https://ipq.org/iq-consortium-creates-foundation-to-address-pharma-lab-data-disconnects-as-momentum-builds-in-second-year/) - The “International Consortium on Innovation and Quality in Pharmaceutical Development” (IQ Consortium) is putting in place a separate foundation to focus on developing a common format for generating, storing, retrieving, transmitting, analyzing and archiving pharmaceutical analytical lab data and the reports generated from that data....
- [China Projected to Become Major Global Vaccine Supplier with WHO Imprimatur and Overhauled Regulatory Infrastructure](https://ipq.org/china-projected-to-become-major-global-vaccine-supplier-with-who-imprimatur-and-overhauled-regulatory-infrastructure/) - The World Health Organization (WHO) certification of China’s FDA (SFDA) as a “competent authority,” and the quality regulatory upgrades the WHO imprimatur reflects, have opened the door for China to become a major player in the global marketplace for vaccines, WHO Director-General Margaret Chan said at the 65th World Health Assembly held in late May in Geneva, Switzerland....
- [Vertex Harnesses QbD to Solve Difficult Formulation and Manufacturing Issues](https://ipq.org/vertex-harnesses-qbd-to-solve-difficult-formulation-and-manufacturing-issues/) - Vertex’ experience with the development and approval of its oral solid hepatitis-C drug Incivek (telaprevir) testifies to the power of quality by design (QbD) to solve the problems posed by molecules that are difficult to develop, formulate and manufacture....
- [Virtual Innovator Vertex Pioneers New QbD Course with CMO Partners](https://ipq.org/virtual-innovator-vertex-charts-new-qbd-course-with-cmo-partners/) - A clear communication pathway with contract partners for escalating issues during and after development has been key to Vertex’ success in building state-of-the-art, quality-by-design (QbD) applications as a virtual company....
- [Analysis of Post-Change Comparability and PEGylation Among Biotech CMC Concerns Drawing FDA Comment at AAPS National Biotech Conference](https://ipq.org/analysis-of-post-change-comparability-and-pegylation-among-biotech-cmc-concerns-drawing-fda-comment-at-aaps-national-biotech-conference/) - The expectations for pre- and post-change lot comparisons and for PEGylation analysis were among FDA CMC application filing concerns addressed by CDER Office of Biotechnology Products (OBP) official Susan Kirschner at an “ask the regulator” session at AAPS’ National Biotech Conference in late May in San Diego, California....
- [Genentech’s Experience with Rituxin Process Bacterial Contamination Reveals Biotech Industry Vulnerabilities and Defense Strategies](https://ipq.org/genentechs-experience-with-rituxin-process-bacterial-contamination-reveals-biotech-industry-vulnerabilities-and-defense-strategies/) - Genentech has been sharing its experience with a novel and difficult-to-detect bacterial contamination in its rituximab cell culture process in the effort to advance the related detection and control science and help arm industry against its recurrence....
- [FDA Expectations for Studying Human Factors in Pre-filled Syringes are Taking Shape](https://ipq.org/fda-expectations-for-studying-human-factors-in-pre-filled-syringes-are-taking-shape/) - FDA is increasing its pressure on sponsors to conduct pre-market human factors (HF) studies for combination products, including pre-filled syringes, and industry is getting clearer on the agency’s expectations as more experience is gained....
- [EMA’s Biotech CMC Focal Points Include Biosimilar Guideline Revisions and Joint Reviews with FDA](https://ipq.org/emas-biotech-cmc-focal-points-include-biosimilar-guideline-revisions-and-joint-reviews-with-fda/) - EMA is nearing release of revised drafts of its biosimilars guidelines to reflect experience gained and stakeholder input and is refining its cooperative application review process with FDA – two of the European agency’s focal points in the biotech CMC arena....
- [ISPE Updates Standards for Assessing Particulate Containment Performance of Pharmaceutical Equipment](https://ipq.org/ispe-updates-standards-for-assessing-particulate-containment-performance-of-pharmaceutical-equipment/) - ISPE has updated its good practice guide (GPG) on “Assessing the Particulate Containment Performance of Pharmaceutical Equipment” to address a broader array of containment technologies, cover new technologies introduced within the past 10 years, and introduce a methodology that can be applied to additional types of equipment other than those referenced in the document. The
- [EMA’s Finalized Biological IMP Quality Guideline Furthers European Clinical and Biotech Review Harmonization](https://ipq.org/emas-finalized-biological-imp-quality-guideline-furthers-european-clinical-and-biotech-review-harmonization/) - EMA’s finalized guideline on “the requirements for quality documentation concerning biological investigational medicinal products in clinical trials” reflects significant changes made to the draft resulting from extensive industry/regulator dialogue and marks an important step in the agency’s efforts to harmonize requirements in the clinical and biotech arenas across Europe....
- [EMA Process Validation Draft Targets Filing Requirements and Assessor Needs](https://ipq.org/ema-process-validation-draft-targets-filing-requirements-and-assessor-needs/) - The European Medicines Agency (EMA) has released a draft process validation (PV) guideline that mirrors FDA’s PV guide in principle, but is aimed more at the content and assessment of marketing authorization applications rather than the execution of validation in a manufacturing facility....
- [Uptick in Data Integrity Problems Leads FDA to Better Define Types and Red Flags](https://ipq.org/uptick-in-data-integrity-problems-leads-fda-to-better-define-types-and-red-flagsbb/) - Un uptick in the number of data integrity problems that FDA is finding at manufacturing and testing facilities is prompting the drug compliance office to better define the forms in which the integrity problems can appear and the red flags that will trigger more intensive investigations....
- [Former FDA Chief Counsels Examine the Shifting Sands of FDA Enforcement Policy](https://ipq.org/former-fda-chief-counsels-examine-the-shifting-sands-of-fda-enforcement-policy/) - The dramatic decline in the number of product seizures was cited as one indicator of the shifting sands of FDA enforcement policy by a panel comprising several decades of former FDA chief counsels at the Food and Drug Law Institute (FDLI) annual meeting in late April in Washington, DC....
- [FDA Field Alert Reports Required for Anomalies That Occur During Distribution](https://ipq.org/fda-field-alert-reports-required-for-anomalies-that-occur-during-distribution/) - FDA expects firms to submit field alert reports (FARs) for recurring technical defects discovered through the complaint process even when there is no evidence of the issues in site production records or retained samples....
- [Operations/Quality & Management/Equipment Disconnects Undermine Industry’s Performance, Manufacturing Veteran Kranking Maintains at ISPE Meeting](https://ipq.org/operationsquality-managementequipment-disconnects-undermine-industrys-performance-manufacturing-veteran-kranking-maintains-at-ispe-meeting/) - The current lack of shop-floor experience in the management ranks together with a lack of training of operations personnel and their disconnection from quality responsibility are manifesting themselves in inefficient processes and recalls and warning letters, veteran manufacturing operations director Larry Kranking stressed at the ISPE Tampa meeting in late February....
- [Inadequate Tech Transfer of Oral Contraceptive Prompts FDA Warning Letter to Warner Chilcott](https://ipq.org/inadequate-tech-transfer-of-oral-contraceptive-prompts-fda-warning-letter-to-warner-chilcott/) - A March warning letter to Warner Chilcott addressing the production of its norethindrone/ethinyl estradiol (EE) contraceptive Ovcon in Puerto Rico highlights FDA’s growing concern that design, development and technical knowledge is not being adequately transferred when products are shifted from one manufacturer to another....
- [PIC/S Provides Guidance to Inspectors on Assessing Quality Risk Management](https://ipq.org/pics-provides-guidance-to-inspectors-on-assessing-quality-risk-management/) - The inter-agency Pharmaceutical Inspection Cooperation Scheme (PIC/S) has released an “Aide-Memoire” intended to assist GMP inspectors in assessing industry’s implementation of quality risk management (QRM) and to help promote a harmonized approach among PIC/S member states....
- [FDA Releases Final Guidance on PET Drug Media Fills; Application Filing Deadline Extended](https://ipq.org/fda-releases-final-guidance-on-pet-drug-media-fills-application-filing-deadline-extended/) - FDA has finalized a guidance on positron emission tomography (PET) drug media fills that was released as a draft last September and has effectively extended the December 2011 deadline for PET drug application submissions until June....
- [FDA GMP Compliance Spotlight Will Remain Centered on Conventional Aseptic Processing](https://ipq.org/fda-gmp-compliance-spotlight-will-remain-centered-on-conventional-aseptic-processing/) - FDA is putting industry on notice that conventional aseptic processing lines not employing isolators or restricted access barrier systems (RABS) will get heightened scrutiny from agency investigators and that a convincing justification will have to be provided for their ability to consistently produce sterile product....
- [Generic Injectable GMPs Again Prompt FDA Warning – APP Added to Non-compliance Watch List](https://ipq.org/generic-injectable-gmp-problems-prompt-another-fda-warning-letter-app-added-to-non-compliance-watch-list/) - Consumer complaint handling and failure investigation issues have placed another large generic injectable drug manufacturer, American Pharmaceutical Partners (APP), onto FDA’s GMP non-compliance watch list....
- [FDA Would Like 483 Responses to Also Address Investigator Concerns Expressed Verbally](https://ipq.org/fda-would-like-483-responses-to-also-address-investigator-concerns-expressed-verbally/) - FDA field compliance officials are recommending that concerns raised verbally during a GMP inspection be addressed in writing by the firm either in its response to a 483 or independently, whether or not a 483 is issued....
- [Merck Serono Biotech API, Injectable and Testing Sites in Europe Draw FDA Warning Letter](https://ipq.org/warning-letter-to-merck-kgaa-draws-gmp-problem-thread-between-api-finished-product-and-testing-facilities-in-europe/) - An FDA warning letter to Darmstadt, Germany-headquartered Merck KGaA reflects GMP problems found during an FDA inspection tour that extended across three Merck Serono European sites involved with biotech products – an API facility, a pre-filled syringe filling plant and a testing lab....
- [FDA SOP on Drug Cargo Theft Includes Public Notification Provision](https://ipq.org/fda-sop-on-drug-cargo-theft-includes-public-notification-provision/) - FDA has published an internal SOP covering industry and agency responsibilities when pharmaceutical cargo thefts occur that provides for the agency to make the final decision regarding if and when the public will be notified of the thefts. The new SOP is included in the agency's “Staff Manual Guide.”...
- [EDQM’s Efforts to Clarify Starting Material Expectations Include Internal Policy Guide; SM Dialogue Continues](https://ipq.org/edqms-efforts-to-clarify-starting-material-expectations-include-internal-policy-guide/) - The European Directorate for the Quality of Medicines and Healthcare (EDQM) has been working hard to better define its policies around starting materials in view of their impact on the regulation of active pharmaceutical ingredients (APIs)....
- [Role of Drug GMP Compliance Problems in Drug Shortages and Plant Market Devaluation Explored at ISPE Conference](https://ipq.org/role-of-drug-gmp-compliance-problems-in-drug-shortages-and-plant-market-devaluation-explored-at-ispe-conference/) - GMP compliance problems at plants producing injectable products not only contribute to drug shortages but can also cause the manufacturing facility with the problems to become devalued and difficult to sell should the firm decide to put the facility on the market, industry experts are cautioning....
- [Control of Heparin Starting Material Draws Guidance from Both FDA and EMA](https://ipq.org/control-of-heparin-starting-material-draws-guidance-from-both-fda-and-emacontrol-of-heparin-starting-material-draws-guidance-from-both-fda-and-ema/) - Both FDA and EMA have issued guidance for industry focused on the control of the biological starting material, porcine mucosa, used to manufacture heparin, that clarifies testing and supply chain expectations....
- [An Upsurge in Recalls of Overweight Tablets and a Recent FDA Warning Letter Show Industry’s Process Understanding Shortcomings](https://ipq.org/an-upsurge-in-recalls-of-overweight-tablets-and-a-recent-warning-letter-show-industrys-process-understanding-shortcomings/) - A marked upswing in recalls of overweight tablets during the past few years and a recent warning letter from FDA point to a lack of understanding by pharma manufacturers of their processes and the many variables that can contribute to producing overweight tablets and not detecting them prior to shipping....
- [EDQM Intensifies Focus on Biotech; USP Also Advancing Biotech Coverage](https://ipq.org/edqm-intensifies-focus-on-biotech-usp-also-advancing-biotech-coverage/) - In mid-February, the European Directorate for the Quality of Medicines & HealthCare (EDQM) announced an ambitious set of efforts aimed at ensuring that the European Pharmacopeia (Ph. Eur.) texts and monographs appropriately cover biologic products, including cellular and gene transfer products and host cell-derived proteins....
- [FDA Commissioner Hamburg Highlights the Role of FDA and Regulatory Science in Drug Innovation](https://ipq.org/fda-commissioner-hamburg-highlights-the-role-of-fda-and-regulatory-science-in-drug-innovation/) - In a compelling speech delivered at the Commonwealth Club of San Francisco in early February, FDA Commissioner Margaret Hamburg cited the approvals of three innovative drugs over the previous month – Genentech’s Erivedge, Vertex’s Kalydeco, and BTG’s Voraxaze – as examples of how the agency is using the advancing regulatory science to create a more flexible and innovation-supportive process that “swiftly and surely reviews product applications that come before us.”....
- [FDA Expands Efforts on Drug Shortages with Cancer Drug Supply Approval Actions and Event Reporting Guidance](https://ipq.org/fda-expands-efforts-on-drug-shortages-with-cancer-drug-supply-approval-actions-and-event-reporting-guidance/) - FDA has announced additional steps to increase the supply of critically needed cancer drugs to help prevent current and future drug shortages, including approval of a foreign substitute product and accelerated approval of a new domestic supplier. The agency has also released a guidance clarifying agency expectations for reporting events that could result in shortages of prescription products....
- [EDQM Launches Harmonized Serialization Program eTACT to Strengthen Europe’s Anticounterfeiting Efforts](https://ipq.org/edqm-launches-harmonized-serialization-program-etact-to-strengthen-europes-anticounterfeiting-efforts/) - On January 26th and 27th, the European Directorate for the Quality of Medicines & Healthcare (EDQM) officially launched its “eTACT” anti-counterfeiting IT-based traceability service with a workshop and live demonstration at its Strasbourg, France headquarters....
- [FDA Release of Biosimilar Guidance Documents Opens Up New Chapter in Dialogue with Industry](https://ipq.org/fda-release-of-biosimilar-guidance-documents-opens-up-new-chapter-in-dialogue-with-industry/) - FDA has released the much-anticipated draft guidance documents on the scientific and quality considerations for registering biosimilar products through the abbreviated licensure pathway established by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) – opening up a new chapter in the dialogue with industry on the future shape of biosimilar regulation in the US....
- [FDA’s Proposed Biosimilar User Fee Structure Explained to Congress by CDER’s Woodcock](https://ipq.org/fdas-proposed-biosimilar-user-fee-structure-explained-to-congress-by-cders-woodcock/) - FDA is proposing to Congress that the initial and annual user fee for biosimilar products in development would be equal to 10% of the fee established for a human drug application under the Prescription Drug User Fee Act (PDUFA) for that fiscal year....
- [A Six-fold Increase in Manufacturing Discontinuance Notices Helps FDA Ease Drug Shortages, Agency Reports at House Hearing](https://ipq.org/increased-manufacturing-discontinuance-notices-help-fda-ease-drug-shortages-agency-reports-at-house-hearing/) - FDA has experienced a six-fold increase in notifications of product discontinuance or other problems that could cause a potential prescription drug supply disruption since an executive order and a follow-up agency letter to manufacturers were issued at the end of October....
- [Genzyme Viral Contamination Lessons Implemented in New Biotech Plant; Virus Control Draws Agency/Industry Dialogue](https://ipq.org/genzyme-viral-contamination-lessons-implemented-in-new-biotech-plant-virus-control-draws-agencyindustry-dialogue/) - FDA’s and EMA’s January inspection clearance of Genzyme’s new production facility in Framingham, Massachusetts marks another significant step in the firm’s recovery process from a viral contamination and GMP compliance problems cited in a consent decree....
- [GMP Consent Decrees Do Not Delimit Litigation and Financial Risks, Skadden, Arps Partner Stresses at FDLI Conference](https://ipq.org/gmp-consent-decrees-do-not-delimit-litigation-and-financial-risks-skadden-arps-partner-stresses-at-fdli-enforcement-conference/) - Consent decrees provide a resolution between FDA and a pharmaceutical manufacturer of the cGMP compliance commitments and non-conformance penalties but do not forestall other types of litigation and generally have a long tail of related liabilities and financial repercussions, Skadden, Arps, Slate, Meagher & Flom Partner Jennifer Bragg stressed at the annual Food & Drug Law Institute (FDLI) Enforcement, Litigation and Compliance Conference in Washington, D.C. in December....
- [Ranbaxy Consent Decree Fires FDA Warning Shot for Ex-US Pharma on Data Integrity](https://ipq.org/ranbaxy-consent-decree-provides-fda-warning-shot-for-ex-us-pharma-on-data-integrity/) - The consent decree signed between Indian generic drug manufacturer Ranbaxy and the US Department of Justice (DoJ) serves as a warning shot across the bow for companies supplying to the US market that FDA findings of falsified information in applications or CGMP records will have very substantial consequences....
- [USP and IPEC-Europe Weigh in on GDPs for Excipients](https://ipq.org/usp-and-ipec-europe-weigh-in-on-gdps-for-excipients/) - USP and the European branch of the International Pharmaceutical Excipients Council (IPEC-Europe) have both released guidance for pharmaceutical companies on the evaluation and handling of excipient distribution....
- [FDA Generic Drugs Office Advances QbD, Review Processes and Quality Management System in Anticipation of User Fees](https://ipq.org/fda-generic-drugs-office-advances-qbd-review-processes-and-quality-management-system-in-anticipation-of-user-fees/) - FDA’s Office of Generic Drugs (OGD) is making significant strides forward in its efforts to implement quality by design (QbD), refine its review processes and implement a quality management system, in anticipation of the resource underpinning that user fees will provide....
- [Consumer Complaints, FDA Inspection at Novartis Nebraska Plant Leads to Recalls and Temporary Manufacturing Shutdown](https://ipq.org/consumer-complaints-fda-inspection-at-novartis-nebraska-plant-leads-to-recalls-and-temporary-manufacturing-shutdown/) - Consumer complaints of bottles containing mixed-up or damaged tablets and capsules and an extended FDA 483 focused on complaint handling at a Lincoln, Nebraska facility where they were made prompted Novartis to recall a handful of its over-the-counter (OTC) products and temporarily cease operations at the plant....
- [Key Pillars of a Quality Culture are Management Commitment, Sharing Inspection Results and Early QbD, Industry Execs Affirm](https://ipq.org/a-quality-culture-is-built-on-management-commitment-sharing-inspection-results-and-early-qbd-industry-execs-affirm/) - Key pillars for global pharmaceutical companies in building effective quality cultures within their organizations and extending them to their contract partners are commitment and communication by senior management, openly sharing inspection information across sites, and a quality-by-design approach beginning in early development, industry executives maintain....
- [Not Keeping Current with Changing FDA Requirements and Slow Responses are Causing ANDA Approval Delays](https://ipq.org/not-keeping-current-with-changing-fda-requirements-and-slow-responses-are-causing-anda-approval-delays/) - Abbreviated New Drug Applications (ANDAs) are improving overall in content and submission format, but errors made due to not keeping up with changing requirements and applicants taking too long to respond to filing deficiencies found by reviewers are delaying some approvals, FDA’s Office of Generic Drugs (OGD) is reporting....
- [Generic Drug Manufacturing Issues Draw FDA Warning Letters at Sandoz and Mylan](https://ipq.org/generic-drug-manufacturing-issues-draw-fda-warning-letters-at-sandoz-and-mylan/) - Oral solid manufacturing drew FDA warning letters in the fourth quarter of 2011 at two of the largest generic companies – Sandoz and Mylan. Injectable production was also implicated in the warning letter received by Sandoz....
- [GDPs, APIs, and non-European GMPs on PIC/S Radar Screen as Membership Expands](https://ipq.org/gdps-apis-and-non-european-gmps-on-pics-radar-screen-as-membership-expands/) - The Pharmaceutical Inspection Cooperation Scheme (PIC/S) is taking a close look at the developing global guidance on good distribution practice (GDP), including the new guidance that has been emerging from Europe and WHO, in assessing its expansion into the GDP arena. Also on PIC/S’ radar screen are active pharmaceutical ingredients (APIs) and the organization’s relationship to the GMPs of its expanding membership – in particular, those of FDA....
- [Quality Culture Indicators Explored by UK Veteran Inspector Thrussell at ICH Q10 Conference](https://ipq.org/quality-culture-indicators-explored-by-uk-veteran-inspector-thrussell-at-ich-q10-conference/) - Key indicators of a healthy quality culture include a company’s understanding of ● the price of noncomformance ● the difference between change control and change management ● and the value of openness with regulators, UK Medicines and Health products Regulatory Agency (MHRA) Expert GMP Inspector Ian Thrussell stressed at a quality systems/ICH Q10 conference in Arlington, Virginia in early October....
- [PIC/S’ Voluntary, Non-Political Status Touted by Regulators Involved](https://ipq.org/pics-voluntary-non-political-status-tauted-by-regulators-involved/) - Regulators involved directly in the Pharmaceutical Inspection Cooperation Scheme (PIC/S) continue to view its voluntary, non-political status as a key component of its effectiveness and do not anticipate a move to change that status....
- [FDA Releases Biosimilar Authorization Performance Goals for Comment as Efforts to Implement the New Act Continue](https://ipq.org/fda-releases-biosimilar-authorization-performance-goals-for-comment-as-efforts-to-implement-the-new-act-continue/) - FDA has released for comment a draft of its 2012-2017 performance goals for authorizing biosimilar products as called for under the terms of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). Comments are due by January 6, 2012....
- [EC Publishes Concept Paper on Safety Features to Support Falsified Medicines Legislation](https://ipq.org/ec-publishes-concept-paper-on-safety-features-to-support-falsified-medicines-legislation/) - In mid-October, the European Commission (EC) published a concept paper for public consultation on proposed requirements for “safety features” for medicinal products as part of its implementation of the EU falsified medicines legislation. Comments are due by April 27, 2012....
- [Anticounterfeiting Initiatives on Criminal Penalties and Serialization Advance in the US and Europe](https://ipq.org/anticounterfeiting-initiatives-advance-in-the-us-and-europe-on-criminal-penalties-and-serialization/) - Lawmakers in the US and Europe are moving forward with initiatives to significantly increase criminal and monetary penalties for the manufacture and distribution of counterfeit drugs and to create an internationally-harmonized serialization system....
- [Growing Cooperation Between FDA and EMA Highlighted in Recent Ben Venue Inspections](https://ipq.org/growing-cooperation-between-fda-and-ema-highlighted-in-recent-ben-venue-inspections-3/) - The mutual focus of FDA and EMA on aseptic processing compliance at Ben Venue’s Bedford, Ohio plant – which has resulted in an EMA recommendation to recall three oncology drugs contract-manufactured by Ben Venue and the firm's decision to cease operations at the facility while the issues raised are being addressed – illustrates the increasing level of cooperation among international agencies in the GMP arena....
- [EMA Scales Back its Roadmap Vision to Match Resource Reality](https://ipq.org/ema-scales-back-its-roadmap-vision-to-match-resource-reality/) - EMA is scaling back the number of projects it will be working on outside of its core business as economic realities and flat staffing levels impact its ability to pursue some longer-term objectives....
- [FDA's ONDQA Bolsters its QbD Review Effectiveness](https://ipq.org/ondqa-bolsters-its-qbd-review-effectiveness/) - FDA is continuing to refine its quality-by-design (QbD ) review framework by creating QbD “CMC lead” and “liaison” positions within the Office of New Drug Quality Assessment (ONDQA), instituting an internal database of QbD application elements for use by reviewers, and increasing collaborative research between ONDQA and academia on QbD-focused topics....
- [Current Staffing Levels at China’s SFDA May Hinder QbD Submissions; Investigational-Stage Changes and Timelines Also at Issue](https://ipq.org/chinas-current-review-policies-and-staffing-levels-at-odds-with-its-ich-q8-10-objectives/) - International pharma is expressing concern that the ability to put ICH Q8-10 principles into practice in China is hampered by the significant limitations in its current review manpower....
- [China’s CMC Harmonization Efforts Provide Opportunities for Industry Input](https://ipq.org/chinas-efforts-to-harmonize-with-international-cmc-regulatory-norms-provides-opportunities-for-industry-input/) - The China State Food and Drug Administration (SFDA) initiative to adopt selected international guidelines offers significant opportunities for industry to work closely with the agency to help it move toward a more science and risk-based approach to its CMC review process in line with the ICH model, industry regulatory experts are stressing....
- [China’s SFDA Begins Inspections of Overseas Manufacturers](https://ipq.org/chinas-sfda-begins-inspections-of-overseas-manufacturers/) - China’s State Food and Drug Administration (SFDA) is initiating inspections of pharmaceutical manufacturing facilities overseas that sell products in China as part of its ongoing effort to modernize and harmonize regulatory practices with international standards and ensure the quality and safety of medicines sold in its country.
- [Airport Radiation Screening-Induced Recall Highlights PET Drug GMP Challenges; FDA Releases PET Media Fill Guidance](https://ipq.org/airport-radiation-screening-induced-recall-highlights-pet-drug-gmp-challenges-fda-releases-pet-media-fill-guidance/) - The challenge and importance of GMP management of positron emission tomography (PET) drug processes is underscored by FDA in a new guidance released in October on PET media fills and exemplified by a recent recall of a prominent PET generator...
- [Significance of 483 Observations Depends on Product Impact, FDA Compliance Officials Explain](https://ipq.org/significance-of-483-observations-depends-on-product-impact-fda-compliance-officials-explain/) - FDA compliance officials are stressing that their judgment of the significance of an investigator's 483 observation is case-specific, reflecting its implications for the quality of product(s) and the firm’s transparency with the agency about that potential impact....
- [Suppliers See Cost/Quality Disconnect in Big Pharma Decision Making](https://ipq.org/suppliers-see-costquality-disconnect-in-big-pharma-decision-making/) - Suppliers are experiencing a significant disconnect between big pharma’s avowed quality-by-design-based supply chain objectives and the actual purchasing decisions it is making based only on price....
- [Pharma Purchasing and Outsourcing Approach Needs Overhauling, Supply Chain Expert Asserts](https://ipq.org/pharma-purchasing-and-outsourcing-approach-needs-overhauling-supply-chain-expert-asserts/) - Regulatory pressure and “true cost” understanding will push pharmaceutical firms to reverse the current outsourcing trend and gain back more control of their critical ingredients and components, supply chain expert Andrew Cox asserts....
- [Congressional and FDA Hearings Throw Spotlight on Drug Shortage Problems and Potential Solutions](https://ipq.org/congressional-and-fda-hearings-throw-spotlight-on-drug-shortage-problems-and-potential-solutions/) - The increasing number of shortages of medically-necessary pharmaceuticals, and of generic injectable drugs in particular, drew the attention of the US Congress and FDA in separate public hearings held in late September....
- [BLA CMC Problem Areas Include Lack of Transparency in Supplement Cover Letters, FDA Reports](https://ipq.org/bla-cmc-problem-areas-include-lack-of-transparency-in-supplement-cover-letters-fda-reports/) - FDA is urging sponsors filing Biologic License Application (BLA) supplements to clearly highlight the significant changes and their scope in the cover letter to expedite the agency review and approval process....
- [FDA Renews Request to Congress for Additional Supply Chain Authorities](https://ipq.org/fda-renews-request-to-congress-for-additional-supply-chain-authorities/) - At a US Senate hearing on September 14, FDA renewed its request for new tools to more effectively and efficiently oversee the global supply chain and better protect the public from substandard, adulterated and counterfeit drug products....
- [Early Attention to Analytical Method Development Can Be Critical to Product Success Later, FDA Cautions](https://ipq.org/early-attention-to-analytical-method-development-can-be-critical-to-product-success-later-fda-cautions/) - FDA is cautioning firms to pay close attention to analytical method development early in the product lifecycle to avoid the problems the agency is seeing during application review stemming from poorly validated methods....
- [FDA’s Foreign Office Experience Supports Their Benefit to Global Supply Chain Regulation](https://ipq.org/experience-at-fdas-foreign-offices-supports-their-benefit-to-global-supply-chain-regulations/) - FDA’s growing experience with the field offices it has established in India, China and eight other countries is substantiating their benefit in boosting the agency’s efficiency and effectiveness in regulating a global supply chain....
- [International Information Sharing is Impacting FDA Inspection and Enforcement Decision-Making](https://ipq.org/international-information-sharing-impacting-fda-inspectionsenforcement-abroad/) - The deepening channels of international information sharing are having an increasing impact on inspection decision-making and activities at FDA....
- [Latin America Diverges Widely on CMC Requirements; Harmonization Effort Continues Through PAHO](https://ipq.org/latin-america-diverges-widely-on-cmc-requirements-harmonization-effort-continues-through-paho/) - While momentum is growing in Latin America for more harmonization around the technical requirements for registering pharmaceuticals, currently there are significant divergences among the countries in the region regarding the expectations for the form and content of CMC submissions....
- [Amgen Glass Lamellae Investigation Sheds Light on Biopharma’s Control Challenges and Solutions](https://ipq.org/amgen-glass-lamellae-investigation-sheds-light-on-biopharmas-control-challenges-and-solutions/) - Amgen’s extensive investigation into the glass lamellae problems it experienced with Epogen, which has included the development of characterization techniques, narrowing down of causal factors, and evaluation of glass manufacturing processes, sheds new light on biopharma’s glass control challenges and the approaches to addressing them....
- [Drug Industry Survey Reveals Wide Disparity in Approaches to Controlling Glass Quality](https://ipq.org/drug-industry-survey-reveals-wide-disparity-in-approaches-to-controlling-glass-quality/) - A PDA-sponsored survey of drug and biologic manufacturers reveals a wide disparity among the practices and approaches being taken to ensure the quality of glass vials and syringes and the products they contain....
- [Sharp Uptick in Recalls for Glass Lamellae Problems Under Scrutiny](https://ipq.org/sharp-uptick-in-recalls-for-glass-lamellae-problems-under-scrutiny/) - A sharp uptick in the number of sterile product recalls due to glass breakage, defects and delamination have the industry, their glass suppliers, and FDA taking a hard look at the reasons for the increase and what can be done to reverse the trend....
- [J&J Board Report Explores Causes of McNeil’s Compliance Breakdowns](https://ipq.org/jj-board-report-explores-causes-of-mcneils-compliance-breakdown/) - A report on an inquiry by a committee of J&J board members into the firm’s recent compliance problems provides insights into how staff reduction, acquisition integration, and communication gaps between operations, company management and the board can contribute to compliance breakdowns in a big pharma organization....
- [New EU Draft Guideline Clarifies, Broadens and Deepens Expectations for GDPs](https://ipq.org/new-eu-draft-guideline-clarifies-broadens-and-deepens-expectations-for-gdps/) - The EU’s new draft guideline on Good Distribution Practices (GDPs) makes a substantial contribution to the product manufacturer-to-patient component of the global regulatory community’s effort to clarify, broaden and deepen GDP regulatory expectations....
- [ICH “Points to Consider” on Implementing Q8-10 Addresses Control Strategy Development and Filing](https://ipq.org/ich-points-to-consider-on-implementing-q8-10-addresses-control-strategy-development-and-filing/) - ICH’s newly-released “Points to Consider” (PTC) on implementing Q8-10 underscores the need for QbD-based marketing applications to provide a scientific justification for the proposed control strategy, including enough information, clearly enough organized, for regulators to understand how the firm developed it....
- [Control Strategy is Nexus for QbD Regulatory Paradigm, US and EU Regulators Affirm](https://ipq.org/control-strategy-is-nexus-for-qbd-regulatory-paradigm-us-and-eu-regulators-affirm/) - CMC review policy makers in the US and Europe are focusing increasing attention on the control strategy as the nexus for the advancing pharmaceutical quality-by-design regulatory paradigm....
- [QbD Imperatives Reaffirmed by Industry Expert Berridge at ISPE Conference](https://ipq.org/qbd-imperatives-reaffirmed-by-industry-expert-berridge-at-ispe-conference/) - Quality by design is a critical tool in navigating the complex manufacturing and supply chain shoals through which pharma is now moving, expert John Berridge reaffirmed at the ISPE Washington Conference in June.
- [ISPE and PDA Initiatives on ICH Q8-10 Implementation Begin Bearing Fruit](https://ipq.org/ispe-and-pda-q8-10-implementation-initiatives-begin-bearing-fruit/) - The parallel efforts by ISPE and PDA to provide practical assistance to industry on how to implement the QbD, risk management and quality system principles outlined in ICH Q8-10 are starting to bear substantial fruit....
- [FDA Micro Lab Data Concerns Continue with Warning Letter to Second Indian Firm](https://ipq.org/fda-micro-lab-data-concerns-continue-with-warning-letter-to-second-indian-firm/) - A warning letter to Ahmedabad, India-based Cadila Healthcare, issued by FDA’s drug compliance office in late June, is the second in as many months to cite an Indian sterile product manufacturer for recording air sampling plate counts that did not match what agency investigators observed during the inspection....
- [EU Moves to Revise its GMP Annex 16 to Clarify QP Role](https://ipq.org/qp-role-under-review-as-eu-moves-to-revise-its-gmp-annex-16/) - The EMA’s Inspector’s Working Group (IWG) is working on a concept paper for revising EU Annex 16 with the aim of better defining and harmonizing the role of the QP across the EU member states....
- [Early Dialogue on Annex 16 Revision Raises Questions About QP/Quality System Relationship](https://ipq.org/early-dialogue-on-annex-16-revision-raises-questions-about-qpquality-system-relationship/) - Key issues for industry as the EU moves to revise Annex 16 will include how much responsibility can reasonably be placed on the QP, how those responsibilities dovetail with the quality system and its management, and the definition of the term “personal knowledge” as used in the current version of the annex and its relationship to auditing....
- [OOS Result Handling Continues as Dominant Theme in FDA Warning Letters Issued Abroad](https://ipq.org/oos-result-handling-continues-as-dominant-theme-in-fda-warning-letters-issued-abroad/) - Giving adequate attention to out-of-specification (OOS) results in batch release decision making and investigation follow up continues as the dominant theme in 2011 in GMP warning letters issued to foreign companies by FDA’s drug and biologic compliance offices....
- [Warning Letter to API Contract Testing Lab Cites Data Misrepresentation to Customers](https://ipq.org/warning-letter-to-api-contract-testing-lab-cites-data-misrepresentation-to-customers/) - A recent FDA warning letter to US-based API contract testing lab Toxin Technologies highlights the agency’s ongoing concern with the communication between contractors and their customers....
- [Lab Data Integrity at Issue in FDA Warning Letters Sent to China and India](https://ipq.org/lab-data-integrity-at-issue-in-fda-warning-letters-sent-to-china-and-india/) - Evidence of unreliable laboratory data has prompted the Office of Compliance at FDA’s Center for Drug Evaluation and Research (CDER) to issue warning letters over the past few months to drug manufacturers in China and India....
- [Multifaceted Falsified Medicines Directive Cleared in Europe; Implementation Will Pose Challenges for Industry and Regulators](https://ipq.org/multifaceted-falsified-medicines-directive-cleared-in-europe-implementation-will-pose-challenges-for-industry-and-regulators/) - Legislation adopted by the EU Council on May 27 will significantly strengthen the EU’s ability to detect falsified medicines and prevent their entry into the legitimate supply chain by adding new requirements in four main areas: ● safety features ● supply chain and good distribution practices (GDPs) ● active substances, and ● Internet sales....
- [EMA’s IMP Guideline Will Provide Shelf-Life Flexibility and EU Harmonization](https://ipq.org/emas-imp-guideline-will-provide-shelf-life-flexibility-and-eu-harmonization/) - Two key thrusts of EMA’s “Guideline on the Requirements for Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials” will be to provide flexibility in shelf-life determination for IMPs and to facilitate harmonization of the clinical trial application process across the EU....
- [FDA May Ask for More Data on Higher Order Protein Structure in Biotech Applications](https://ipq.org/fda-may-ask-for-more-data-on-higher-order-protein-structure-in-biotech-applications/) - As methods and technologies designed to unravel the complexities and intricacies of protein folding, three-dimensional structure and function become more reliable and available, FDA is looking at whether it is time to begin requiring more detailed information on higher order protein structure in biotech product applications....
- [IPAC-RS is Advancing GMP Consciousness Among Inhalation Product Component Suppliers; New PS 9000 Will Allow Certification](https://ipq.org/ipac-rs-is-advancing-gmp-consciousness-among-inhalation-product-component-suppliers-new-ps-9000-will-allow-certification/) - The multi-faceted effort by the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) to instill the quality management concepts detailed in its component GMP guidelines into the complex supply chain for orally inhaled and nasal drug products (OINDPs) is continuing to bear fruit....
- [Complying With Serialization Mandates Requires Long Lead Times, Experts Warn](https://ipq.org/complying-with-serialization-mandates-requires-long-lead-times-experts-warn/) - Serialization experts are warning pharma companies that compliance with looming serialization requirement deadlines will require long lead times....
- [“Stability Budget” to Assure Quality During Drug Distribution Proposed by PDA Task Force with ICH Adoption in Mind](https://ipq.org/stability-budget-to-assure-quality-during-drug-distribution-proposed-by-pda-task-force-with-ich-adoption-in-mind/) - A “stability budget” is being proposed by a PDA task force as a viable approach for industry in its efforts to fill an important gap in assuring the quality of pharmaceutical products through the full-length of their distribution process....
- [ICH Position Papers Will Address Pressing Issues in Q8-10 Implementation; EU Experience Helps Shed Light](https://ipq.org/ich-position-papers-will-address-pressing-issues-in-q8-10-implementation-eu-experience-helps-shed-light/) - The ICH Quality Implementation Working Group (IWG) is progressing in its effort to develop a series of six position papers covering issues identified by the industry and health agency participants at the 2010 ICH Q8-10 training sessions as needing further clarification. The IWG is planning to complete the six papers by the end of 2011....
- [GS1 Global Standards Gaining Traction as Drug Serialization Deadlines Loom](https://ipq.org/gs1-global-standards-gaining-traction-as-drug-serialization-deadlines-loom/) - GS1’s globally harmonized serial number approach continues to gain traction as pharmaceutical manufacturers seek to navigate the complicated maze of international regulatory requirements and comply with their looming deadlines....
- [More Guidance Forthcoming from FDA’s Office of Combination Products on CMC & GMP Expectations](https://ipq.org/more-guidance-forthcoming-from-fdas-office-of-combination-products-on-cmc-gmp-expectations/) - FDA’s Office of Combination Products (OCP) will be sharing its growing knowledge base through new guidances and updates to its existing library that will help CP manufacturers better understand the regulatory expectations and navigate the shoals of marketing clearance....
- [Communication with Reviewing Authorities Key to Combination Product Success in Europe and Japan](https://ipq.org/communication-with-reviewing-authorities-key-to-combination-product-success-in-europe-and-japan/) - Communication with reviewing authorities is critical in navigating the combination product regulatory shoals in Europe and Japan as it is in the US. However, the communication channels are not always well-marked, and they differ in each of the three ICH regions....
- [Risk-based Approach to Combination Products Advocated to Improve Communications with Regulators and Streamline Filing](https://ipq.org/risk-based-approach-to-combination-products-advocated-to-improve-communications-with-regulators-and-streamline-filing/) - A risk-based approach could clarify and simplify the regulatory pathway for combination products, Lilly CMC Regulatory Affairs Principle Consultant LeAnn Chambers maintained at a DIA CMC Workshop in February....
- [Year-End Filing Deadline Causing a Flurry of Activity for PET Drug Makers and Regulators](https://ipq.org/year-end-filing-deadline-causing-a-flurry-of-activity-for-pet-drug-makers-and-regulators/) - A December 12, 2011 filing deadline for new and abbreviated new drug applications (NDAs/ANDAs) for all positron emission tomography (PET) drugs currently in commercial clinical use is putting heat on manufacturers and FDA to address the outstanding quality regulatory issues for this unique and challenging class of high-tech injectable products....
- [Recent PET Drug Inspection Findings Shed Light on Upcoming FDA Focal Points](https://ipq.org/recent-pet-drug-inspection-findings-shed-light-on-upcoming-fda-focal-points/) - Recent inspection findings at positron emission tomography (PET) drug manufacturing facilities regarding sterility assurance, testing, training and quality oversight provide insight into what FDA investigators will be looking for when inspecting these manufacturers – most for the first time....
- [Relationships, Communication Gaps for Atypical Actives Aired at PDA/FDA Workshop](https://ipq.org/relationships-communication-gaps-for-atypical-actives-aired-at-pdafda-workshop/) - The relationships and the communication gaps between ingredient producers, distributors, dosage form manufacturers and regulators when atypical actives are involved received a public airing at a workshop cosponsored by PDA and FDA in March in Bethesda, Maryland....
- [Insights from Atypical Actives Workshop Could Drive Needed Technical/Regulatory Guidance, Participants Affirm](https://ipq.org/insights-from-atypical-actives-workshop-could-drive-needed-technicalregulatory-guidance-participants-affirm/) - The insights that emerged at a PDA/FDA workshop on atypical active ingredients could form the basis for guidance that would clarify the regulatory expectations involved and help close the existing communication gaps in the manufacturing and distribution chain....
- [McNeil Consent Decree Reflects Previous Big Pharma Injunctions Minus Disgorgement](https://ipq.org/mcneil-consent-decree-reflects-previous-big-pharma-injunctions-minus-disgorgement/) - The consent decree signed between McNeil and the U.S. Department of Justice on March 10 covering its Fort Washington, Lancaster and Las Piedras facilities contains the standard CGMP injunction provisions for independent expert consultant oversight and monetary penalties if the specified remediation timetables are not met. However, it does not include the large “disgorgement” fines characteristic of similar big pharma injunctions over the past decade....
- [FDA Unapproved Drugs Initiative Orders Hundreds of Cough/Cold Products off the Market](https://ipq.org/deltex-injunction-follows-history-of-lab-gmp-and-unapproved-drug-compliance-problems-2/) - FDA is taking another significant step in its unapproved drug enforcement initiative by ordering that hundreds of oral prescription (Rx) drugs used to treat coughs and colds be taken off the market....
- [Deltex Injunction Follows History of  Lab GMP and Unapproved Drug Compliance Problems](https://ipq.org/deltex-injunction-follows-history-of-lab-gmp-and-unapproved-drug-compliance-problems/) - An injunction against Texas-based prescription and over-the-counter (OTC) drug contract manufacturer Deltex is forcing the firm to shut down operations and recall all products manufactured since it received an FDA warning letter in 2008....
- [Continuous Manufacturing does not Present Regulatory Hurdles, FDA Experts Say](https://ipq.org/continuous-manufacturing-does-not-present-regulatory-hurdles-fda-experts-say/) - The regulatory definitions of “batch” and “lot” do not present hurdles for implementing continuous manufacturing, FDA is stressing in highlighting the potential the new processing approaches offer to advance the objectives of its 21st Century quality initiative....
- [Quality System Adjustments Needed for Continuous Manufacturing](https://ipq.org/quality-system-adjustments-for-continuous-manufacturing-explored-by-fda/) - The quality system adjustments needed to accommodate continuous manufacturing are getting attention at regulator/industry forums where the dialogue on how to drive forward the new processing technologies is underway....
- [Extensive Vetting of FDA’s Draft Process Validation Guidance Smoothes Its Transition to Final Form](https://ipq.org/extensive-vetting-of-fdas-draft-process-validation-guidance-smoothes-its-transition-to-final-form/) - The extensive vetting process on FDA’s draft process validation guidance confirmed to the agency that only a relatively few clarifications were needed to bring the draft into final form....
- [California’s Findings of Gaps in Heparin Recalls Highlighted at FDA Track and Trace Workshop](https://ipq.org/californias-findings-of-gaps-in-heparin-recalls-highlighted-at-fda-track-and-trace-workshop/) - Evidence of the gaps in the 2008 heparin recall process uncovered by the State of California underscores the need for a track and trace system for prescription drug products, CA State Board of Pharmacy Executive Officer Virginia Herold maintained at an FDA-sponsored public workshop on February 15-16 at its White Oak, MD campus....
- [Korea is Pressing Forward on CMC/GMP Harmonization Quest](https://ipq.org/korea-is-pressing-forward-on-cmcgmp-harmonization-quest/) - Korea’s quest to more closely harmonize its CMC and GMP quality regulatory processes with ICH/global norms is creating openings for outside companies and regulators to work with the Korean FDA (KFDA) to resolve remaining differences.
- [Baxter Puerto Rico Warning Letter, Recalls Follow FDA Findings of Problems with Complaint Investigations](https://ipq.org/baxter-puerto-rico-warning-letter-recalls-follow-fda-findings-of-problems-with-complaint-investigations/) - FDA findings during a mid-2010 inspection at Baxter’s facility in Jayuya, Puerto Rico that appropriate action had not been taken to resolve problems reported in complaints and confirmed in the firm’s own internal investigations resulted in a multi-product recall the following month, a follow-up inspection of a companion facility in Puerto Rico two weeks after the recall, and an FDA warning letter covering both facilities three months later in late January....
- [Heparin API Manufacturer SPL Draws Warning for Complaint Handling and Supplier Auditing](https://ipq.org/heparin-api-manufacturer-spl-draws-warning-for-complaint-handling-and-supplier-auditing/) - Inadequate follow up to customer complaints – a key theme in recent FDA drug GMP warning letters – was again on the front burner in a warning letter issued in late January to Scientific Protein Laboratories (SPL) in the wake of the agency’s continuing investigation into the 2008 heparin contamination crisis....
- [Value of Attribute Risk Ranking in Process Development Recognized by ICH Q11 EWG](https://ipq.org/value-of-attribute-risk-ranking-in-process-development-recognized-by-ich-q11-ewg/) - The current working draft of ICH Q11 promotes the use of risk ranking of quality attributes as a valuable tool in applying quality-by-design (QbD) principles to biotech drug substance development and manufacturing....
- [EU Documentation GMPs Updated to Reflect Electronic Records and Quality Systems Mindset](https://ipq.org/eu-documentation-gmps-updated-to-reflect-electronic-records-and-quality-systems-mindset/) - The European Union has updated its GMP expectations for documentation to reflect the realities of electronic record keeping and the evolving quality systems-based regulatory framework....
- [EU GMP Annex 11 Revision Adds Risk Assessment, Contractor and Validation Coverage for Computer Systems](https://ipq.org/eu-annex-11-revision-adds-risk-assessment-contractor-and-validation-coverage/) - The revision of Annex 11 to the EU GMPs on computerized systems, released in mid-January, calls for the application of risk management principles through the system lifecycle and clarifies the expectations for third party service providers and validation....
- [ICH Q11 Process Validation Discussion Will Be at High Level Given Guideline’s Scope](https://ipq.org/q11-process-validation-discussion-will-be-at-high-level-given-guidelines-scope/) - The ICH Q11 Expert Working Group (EWG) is settling on a high level approach to addressing process validation in its drug substance development and manufacturing guideline, reflecting the challenges of encompassing drug and biotech products and the evolving expectations across the three regions....
- [ICH Q11 Draft Gelling On Lifecycle/Change Management and Control Strategy Components](https://ipq.org/q11-draft-gelling-on-lifecyclechange-management-and-control-strategy-2/) - The lifecycle management section of the newest working draft of ICH’s Q11 guideline on drug substance development and manufacturing provides allowance for applicants to include change management proposals in their original submissions....
- [McNeil Recalls Products for Cleaning Concerns Based on “Comprehensive Action Plan” Review](https://ipq.org/mcneil-recalls-products-for-cleaning-concerns-based-on-comprehensive-action-plan-review/) - McNeil’s findings under its “Comprehensive Action Plan” (CAP) of cleaning issues at its Fort Washington, PA plant has resulted in another round of over-the-counter (OTC) product recalls....
- [FDA’s Focus On Lab Practices Abroad Continues in Four Recent API Warning Letters](https://ipq.org/fdas-focus-on-lab-practices-abroad-continues-in-four-recent-api-warning-letters/) - Laboratory practices – a recurrent area of concern in FDA inspections abroad – again took center stage in a series of warning letters issued by the Center for Drug Evaluation and Research (CDER) compliance office to four foreign active pharmaceutical ingredient (API) manufacturers in December....
- [FDA Re-inspection Findings at McNeil’s Fort Washington Plant Track Those at Las Piedras; Recall Problems Continue](https://ipq.org/fda-re-inspection-of-mcneils-fort-washington-plant-tracks-las-piedras-findings-recall-problems-continue/) - A similar litany of concerns centering on the handling of complaints, deviations and recalls and their interrelationship was raised during FDA’s follow-up investigation at McNeil’s Fort Washington facility completed in mid-December as was found in the follow-up at its Las Piedras, Puerto Rico plant that ended a few weeks earlier....
- [PIC/S Site Master File Guide Updated on Quality Management System Expectations](https://ipq.org/pics-site-master-file-guide-updated-on-quality-management-system-expectations/) - The Pharmaceutical Inspection Cooperation Scheme (PIC/S) has adopted a rewrite of its site master file (SMF) guide for industry that upgrades the expectations on quality management systems (QMS) – and the quality risk management (QRM) and supply chain components in particular – to keep pace with ICH Q9 and Q10....
- [Membership & US Entry, GDPs, QRM Guidance and Traditional/Herbal Medicine Inspections Draw PIC/S Attention](https://ipq.org/membership-applications-gdps-qrm-guidance-and-traditionalherbal-medicine-inspections-draw-pics-attention/) - FDA’s entry into the Pharmaceutical Inspection Cooperation Scheme (PIC/S) at the beginning of 2011 will be marked by the participation of Commissioner Margaret Hamburg at PIC/S’ upcoming 40th anniversary symposium on “Challenges and Future Perspectives” in Geneva, Switzerland in late May....
- [More Guidance on Transport Storage Conditions Targeted by EMA](https://ipq.org/more-guidance-on-transport-storage-conditions-targeted-by-ema/) - The European Medicines Agency (EMA) is proposing to expand its guidance on transport storage conditions to better address the challenges of an increasingly complex ingredient supply and product distribution chain....
- [Analytical Method Transfer In Focus in EU Effort to Revise GMP Chapter 6 on Quality Control](https://ipq.org/analytical-method-transfer-in-focus-in-eu-effort-to-revise-gmp-chapter-6-on-quality-control/) - The transfer of analytical laboratory methods within and between companies is being targeted by the European Medicines Agency (EMA) to receive more attention in a revision to its EU GMP Guide Chapter 6 on quality control....
- [McNeil's Compliance Problems Continue With New FDA Inspection Findings and a Recall](https://ipq.org/mcneils-compliance-problems-continue-with-new-fda-inspection-findings-and-a-recall/) - Compliance problems continued to plague J&J’s OTC drug subsidiary McNeil in November with the firm announcing the recall of another bolus of children’s medicines made at its Fort Washington plant and the receipt of a substantial 483 from FDA investigators at the conclusion of a lengthy inspection of its Las Piedras, Puerto Rico facility....
- [Active Ingredient and Starting Material Supply Chains in Focus in Draft Revision to EU GMP Guide Chapter 5](https://ipq.org/active-ingredient-and-starting-material-supply-chains-in-focus-in-draft-revision-to-eu-gmp-guide-chapter-5/) - The European Commission (EC) has released for comment a revision to EU GMP Guide Chapter 5 on production that provides new requirements for control of active ingredient and starting material supply chains, including reports documenting periodic supplier audits for inspector review....
- [Mold Contamination in Claris IV Bags Results in Class I Recalls, Warning Letter and Import Alert](https://ipq.org/mold-contamination-in-claris-iv-bags-results-in-class-i-recalls-warning-letter-and-import-alert/) - The findings of fungal contamination in IV bags contract-manufactured at Claris Lifesciences’ Ahmedabad, India facility has resulted in a three-product Class I recall, an FDA warning letter and a U.S. import alert on Claris products....
- [Contamination Control in Aseptic Processing Draws FDA Warning in U.K.](https://ipq.org/contamination-control-in-aseptic-processing-draws-fda-warning-in-u-k/) - FDA inspection observations in late July of evidence of mold contamination in a Class 100 aseptic suite and inadequate controls in place to prevent it led to a warning letter to Wrexham, U.K.-based CP Pharmaceuticals at the end of October....
- [China’s Quality Regulatory Process Evolving Toward the Western Model](https://ipq.org/chinas-quality-regulatory-process-evolving-toward-the-western-model/) - China’s quality regulatory process is evolving toward the Western model as it draws on and incorporates guidance from the EMA, WHO, FDA and ICH....
- [New Draft Broadens EU GMP Guide Chapter 7 from Contracting to All Outsourced Activities](https://ipq.org/new-draft-broadens-eu-gmp-guide-chapter-7-from-contracting-to-all-outsourced-activities/) - The European Commission has released for comment a revision to Chapter 7 of the EU GMP Guide on outsourced activities that expands the scope of coverage and incorporates quality system and risk management principles from ICH Q9&10....
- [FDA Preapproval Inspections Enhanced by New Guidance, Reviewer Participation](https://ipq.org/fda-preapproval-inspections-enhanced-by-new-guidance-reviewer-participation/) - Increased reviewer engagement with investigators is impacting the preapproval inspection (PAI) process and helping FDA address the growing complexity of products and processes it faces in reviewing new drug applications (NDAs) and their supplements (sNDAs)....
- [House Committee Surveying FDA’s Puerto Rico District 2000-2010 Oversight Activities](https://ipq.org/house-committee-surveying-fdas-puerto-rico-district-2000-2010-oversight-activities/) - The House Committee on Oversight and Government Reform is requesting that FDA provide a wide variety of documents pertaining to the last decade of compliance oversight by its Puerto Rico field office....
- [Make Interchangeability Decision After Biosimilar Approval, Amgen Urges FDA](https://ipq.org/make-interchangeability-decision-after-biosimilar-approval-amgen-urges-fda/) - A proposal for a two-tiered system that would require a biological product to be approved first as a biosimilar and then later become applicable for “interchangeable” status with a reference product using post-marketing data drew attention at an FDA public meeting on November 2-3 at the agency’s White Oak campus in Silver Spring, Maryland....
- [Japan’s Foreign Inspections Reveal Communication Chain Gaps](https://ipq.org/japans-foreign-inspections-reveal-communication-chain-gaps/) - Foreign inspections by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) are revealing gaps in the communication chain between marketing authorization holders in Japan, their overseas suppliers and the Japanese caretakers of the supplier’s master files, PMDA’s Liaison Officer with EMA Yoshikazu Hayashi reported at the annual meeting of the Active Pharmaceutical Ingredient Council (APIC) in Barcelona, Spain in late October....
- [Increasing Cargo Theft of Pharmaceuticals May Have Brand Impact and Result in Recalls](https://ipq.org/increasing-cargo-theft-of-pharmaceuticals-may-have-brand-impact-and-result-in-recalls/) - The significant increase in pharmaceutical cargo thefts in the US carries hidden consequences for drug firms beyond the dollar loss they incur, including damaged reputations and the need to perform product recalls....
- [New Warning Letters in US Focus on Process Validation and Sponsor/Contractor Relations](https://ipq.org/new-warning-letters-in-us-focus-on-process-validation-and-sponsorcontractor-relations/) - Drug GMP warning letters issued in mid-October to Hauppage, New York-based Contract Pharmacal and to Advanced Testing Laboratory in Cincinnati, Ohio shed light on FDA’s compliance expectations for two front-burner issues – process validation and sponsor/contractor communications....
- [FDA, USP and CHPA Team Up to Address OTC Drug Impurity Problems](https://ipq.org/fda-usp-and-chpa-team-up-to-address-otc-drug-impurity-problems/) - A committee comprised of experts representing FDA, the US Pharmacopeia (USP) and the Consumer Healthcare Products Association (CHPA) is considering how to strengthen the control of impurities in over-the-counter (OTC) products....
- [FDA Raises Tablet Contractor Validation, Aseptic Processing Concerns at Gilead](https://ipq.org/fda-raises-tablet-contractor-validation-aseptic-processing-concerns-at-gilead/) - Tablet contractor process revalidation and aseptic processing of injectible AmBisome were areas of concern addressed in a warning letter from FDA’s Los Angeles District office to San Dimas, CA-based Gilead Sciences in late September....
- [Product Quality Responsibilities Shared Between CMOs and Sponsor Firms Under FDA Scrutiny](https://ipq.org/product-quality-responsibilities-shared-between-cmos-and-sponsor-firms-under-fda-scrutiny/) - FDA is putting industry on notice that relationships between sponsors and contract manufacturing organizations (CMOs) will be receiving close attention during upcoming agency inspections....
- [J&J’s “Phantom Recall” and Communication with FDA Probed During House Hearing](https://ipq.org/jjs-phantom-recall-and-communication-with-fda-probed-during-house-hearing/) - Johnson & Johnson’s “phantom recall” of subpotent Motrin and its communications with FDA were focal points at a US House of Representatives Committee on Oversight and Government Reform hearing on September 30....
- [WHO Guideline on QRM Taking Shape](https://ipq.org/who-guideline-on-qrm-taking-shape/) - The World Health Organization (WHO) asked specific stakeholders in August to comment on a working draft of a detailed guideline it is preparing on the expectations for quality risk management (QRM) in pharmaceutical manufacturing. The guideline will update WHO’s advice to industry and regulatory bodies in the risk assessment area and align it with more recent documents published by other international regulatory authorities....
- [Congressional Committee Has More Questions for J&J’s Weldon](https://ipq.org/congressional-committee-has-more-questions-for-jjs-weldon/) - J&J’s CEO William Weldon has been invited to appear before the House Committee on Oversight and Government Reform to explain the contents of e-mail messages uncovered in the committee’s investigation into the company’s recall of children’s medicines earlier this year....
- [FDA Gathering Biosimilar Stakeholders for Input on Implementing the New Legislation](https://ipq.org/fda-gathering-biosimilar-stakeholders-for-input-on-implementing-the-new-legislation/) - FDA will be holding a two-day public hearing to obtain input on specific issues and challenges associated with the implementation of the new biosimilars legislation. The meeting is set for November 2-3 at FDA’s White Oak campus in Silver Spring, MD....
- [US House Proposing to Equip and Fund FDA for Increased Global Oversight](https://ipq.org/us-house-proposing-to-equip-and-fund-fda-for-increased-global-oversight/) - Key players in the US House of Representatives have put on the table a draft of comprehensive legislation aimed at strengthening FDA’s recall and overseas inspection authorities and requiring new supply chain accountability for drug companies. The bill is intended to help FDA respond to the increasing challenges it faces in regulating a global pharmaceutical marketplace....
- [Excipient Master File System Advocated for EU](https://ipq.org/excipient-master-file-system-advocated-for-eu/) - An excipient master file (EMF) system in the EU would facilitate the review process, spur excipient R&D and harmonize with other regulatory systems, advocates are saying....
- [KV Resumes Drug Shipments of Its First Product After Successful FDA Inspection](https://ipq.org/kv-resumes-drug-shipments-of-its-first-product-after-successful-fda-inspection/) - KV Pharmaceuticals announced on September 10 that it will restart shipment of its potassium chloride capsule product Micro-K after a successful inspection in August of its St. Louis facility and a letter from FDA this month giving the firm permission to resume manufacturing and distribution of the product....
- [McNeil’s 2000–2010 Inspection Record Shows a Mixed Bag of Compliance for its PA and PR Sites](https://ipq.org/mcneils-2000-2010-inspection-record-shows-a-mixed-bag-of-compliance-for-its-pa-and-pr-sites/) - Since mid-July, FDA has made public 483s and establishment inspection (EIR) reports from 17 inspections of McNeil facilities, showing a mixed bag of compliance over the last decade....
- [Willing Parties, Quality Agreements and Information From Suppliers All Needed For Supply Chain Risk Management, CDER’s Friedman Stresses](https://ipq.org/willing-parties-quality-agreements-and-information-from-suppliers-all-needed-for-supply-chain-risk-management-cders-friedman-stresses/) - Willing parties, quality agreements and information from suppliers are all needed along with auditing programs in managing pharmaceutical supply chain risks, CDER Office of Compliance Division of Manufacturing and Product Quality (DMPQ) Director Richard Friedman stressed in addressing industry/regulator initiatives to strengthen supply chain integrity....
- [Cooperative Supply Chain Integrity Efforts Important to Support Advancing Track-and-Trace/Authentication Technologies and QC Analytical Methods](https://ipq.org/track-and-traceauthentication-technologies-qc-analytical-methods-are-advancing-to-support-cooperative-supply-chain-integrity-efforts/) - Broad-based cooperation vertically across the supply chain and horizontally across organizations and regions is important to help support the advancements in track-and-trace/product authentication technologies and QC analytical methods, CDER compliance official Richard Friedman emphasizes....
- [Update From FDA on its Secure Supply Chain Pilot Coming Soon;  Regulation, Legislation and Guidance Efforts Advance in US and EU](https://ipq.org/update-from-fda-on-its-secure-supply-chain-pilot-coming-soon-regulation-legislation-and-guidance-efforts-advance-in-us-and-eu/) - A status update and further announcements from FDA on its “Secure Supply Chain” (SSC) pilot program, intended to help promote the safety of active ingredients and drug products imported into the US, is expected soon....
- [MHRA Has Been Rejecting One-Third of Type IA Variation Notifications Due to Information Shortcomings](https://ipq.org/mhra-finds-one-third-of-type-ia-variation-notifications-are-being-rejected/) - Almost one-third of Type IA variation notifications are being rejected by Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) due to not meeting the filing criteria or including the right administrative information, according to an assessment by MHRA covering the six months since the new EU variations regulations became effective....
- [Separate Review Track Proposed for Design Space to Avoid Marketing Application Approval Delays](https://ipq.org/separate-review-track-proposed-for-design-space-to-avoid-marketing-application-approval-delays/) - A separate review track for design spaces could allow more room for industry/regulator dialogue on the issues involved without delaying the clearance process for the marketing application, Health Canada Center for the Evaluation of Radiopharma-ceuticals and Biotherapeutics Director Anthony Ridgway suggested at a CMC Strategy Forum on implementing quality by design (QbD) cosponsored by the biotech science society CASSS and FDA in mid-July....
- [India Strengthening its Central Regulatory Authority to Keep Pace with Industry Expansion](https://ipq.org/india-strengthening-its-central-regulatory-authority-to-keep-pace-with-industry-expansion/) - India is working to strengthen its central drug regulatory authority and related laws and regulations in response to its rapidly expanding domestic industry and the need for more interaction with foreign regulatory counterparts....
- [FDA/EMA Joint Inspection Program for Finished Products Seeking Applicants](https://ipq.org/fdaema-joint-inspection-program-for-finished-products-seeking-applicants/) - The EMA is continuing to seek drug manufacturers willing to participate in its joint inspection program with FDA for finished products. In an August 11 announcement, EMA explained that companies that have submitted two equivalent applications for the same product to both EMA and FDA can request to participate in the pilot....
- [New Senate Bill Proposes Supply Chain Requirements for Drug Firms, Mandatory Recall Authority for FDA](https://ipq.org/new-senate-bill-proposes-supply-chain-requirements-for-drug-firms-mandatory-recall-authority-for-fda/) - A bill introduced in the Senate in early August would amend the Food, Drug and Cosmetic (FD&C) Act to provide FDA with new monetary penalty and recall tools and require drug firms to audit and document the steps in their product ingredient supply chains....
- [FDA Releases Q&A on Recalls, Holding and Distribution of Human Drugs](https://ipq.org/fda-releases-qa-on-recalls-holding-and-distribution-of-human-drugs/) - FDA provided on its website in early August a Q&A giving additional guidance on human drug recalls – their purpose, FDA’s authority to mandate them, over-the-counter (OTC) drug versus prescription drug recalls, and related investigations....
- [CDER Will Focus on Part 11 Compliance in Upcoming Inspections](https://ipq.org/cder-will-focus-on-part-11-compliance-in-upcoming-inspections/) - FDA’s Center for Drug Evaluation and Research (CDER) will be conducting a series of inspections of drug manufacturers that will evaluate the industry’s understanding of and compliance with the Part 11 regulations. The inspection findings will be used to assess whether or not its related regulations and guidance need to be adjusted....
- [MHRA Pursuing New Monetary and Statutory Sanctions for Non-compliance](https://ipq.org/mhra-pursuing-new-monetary-and-statutory-sanctions-for-non-compliance/) - The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is actively exploring the addition to its enforcement toolbox of a range of monetary and statutory sanctions for use against non-compliant drug manufacturers, similar to those available to FDA....
- [EU Restructuring PAT Team to Help Address Communication Challenges of the New Quality Paradigm](https://ipq.org/eu-restructuring-pat-team-to-help-address-communication-challenges-of-the-new-quality-paradigm/) - The EMA is restructuring its PAT Team to advance the team’s role in facilitating the communication within the agency and with industry needed to further the ICH Q8-10/QbD objectives....
- [ICH Q4B Annex 13 on Powder Density and Annex 14 on Bacterial Endotoxin Testing Out for Comment](https://ipq.org/ich-q4b-annex-13-on-powder-density-and-annex-14-on-bacterial-endotoxin-testing-out-for-comment/) - FDA has made available for comment the Step 2 drafts of ICH Q4B Annex 13 covering the bulk density and tapped density of powders and Annex 14 on bacterial endotoxin testing. The drafts were cleared for release by the ICH Steering Committee meeting in June....
- [WHO Proposes New Guideline for Microbiology Labs and Adjustments to Site Master File, Water and HVAC Guides](https://ipq.org/who-proposes-new-guideline-for-microbiology-labs-and-adjusts-site-master-file-and-water-guides/) - WHO is expanding its guidance library to focus specifically on GMP expectations for microbiology labs and is adjusting its existing guidelines on drafting site master files, on water used in pharmaceutical manufacturing and on heating, ventilation, and air-conditioning (HVAC) systems....
- [Complaint and Deviation Handling, Contamination Control Continue to Draw FDA Attention at Vaccine Plants](https://ipq.org/complaint-and-deviation-handling-contamination-control-continue-to-draw-fda-attention-at-vaccine-plants/) - Complaint and deviation handling/reporting and contamination control – concerns that have been in the forefront of FDA attention during vaccine manufacturing inspections – were again focal points at a March/April inspection of Sanofi Pasteur’s vaccine plant in Marcy l’Etoile, France that resulted in an “untitled letter” from the agency on July 22....
- [Potential GMP Trouble Spots at India’s API Firms Include Equipment Handling, CAPA, Documentation, and Training, India Auditing Expert Finds](https://ipq.org/potential-gmp-trouble-spots-at-indias-api-firms-include-equipment-handling-capa-documentation-and-training-india-auditing-expert-finds/) - Potential GMP concerns among India’s expanding number of API suppliers include equipment handling, CAPA, documentation and training, Semler Research Center COO/Director Gurudatta Gayatri reported at the DIA Annual Meeting in June....
- [J&J Tallies Up the Impact of its Compliance and Recall Problems in Quarterly Investor Update](https://ipq.org/jj-tallies-up-the-impact-of-its-compliance-and-recall-problems-in-quarterly-investor-update/) - During a July 20 J&J investor’s conference call covering the company’s second quarter results, Investor Relations VP Louise Mehrotra provided an update on J&J/McNeil’s current compliance situation and the significant financial and operational impact of the firm’s compliance and recall problems (IPQ “In the News” May 6, 2010)....
- [FDA Concern with McNeil’s Complaint Handling Extends to Lancaster, PA Facility](https://ipq.org/fda-concern-with-mcneils-complaint-handling-extends-to-lancaster-pa-facility/) - McNeil’s complaint handling – a problem area cited in FDA’s January warning letter to parent company J&J regarding their Las Piedras, Puerto Rico plant and in an April inspection at the OTC drug manufacturer’s Fort Washington facility (IPQ “In the News,” May 6, 2010) – was also of concern to agency investigators in an inspection completed July 9 at McNeil’s plant in Lancaster, PA.
- [International Joint API Inspection Pilot Program Sees Positive Results](https://ipq.org/international-joint-api-inspection-pilot-program-sees-positive-results/) - The international API pilot joint inspection program involving regulatory authorities in the EU, US, and Australia is resulting in rapid sharing of inspection reports for non-compliant sites, follow-up inspections at other facilities owned by the companies found to have non-compliant sites, and prompt notification of regulatory actions taken....
- [Communication Between CMC and Clinical Groups is Key in IND Phase, FDA says](https://ipq.org/communication-between-cmc-and-clinical-groups-is-key-in-ind-phase-fda-says/) - FDA Center for Drug Evaluation and Research (CDER) is stressing that communication problems between the CMC and clinical groups working in Phase I can result in important risks not being identified and can impede IND/Phase I progress....
- [Preparing for and Communicating Manufacturing Changes During Late Stage Development Smoothes Biotech Clearance Process with FDA](https://ipq.org/preparing-for-and-communicating-manufacturing-changes-during-late-stage-development-smoothes-biotech-clearance-process-with-fda/) - Comparability studies for changes which inevitably occur during Phases II and III for biotech products must be planned for by the firms conducting them, FDA is stressing. The agency is also cautioning that communication with FDA during the end-of-Phase-II and pre-Biologic License Application (BLA) meetings and through the submission and preapproval inspection process.is important to understand common expectations and make it easier to work through issues that will arise due to these changes....
- [ICH Q11 Guideline Structure and Content Taking Shape](https://ipq.org/ich-q11-guideline-structure-and-content-taking-shape/) - The structure and content of ICH Q11 on drug substance development and manufacturing is taking shape as the Expert Working Group (EWG) resolves the challenging issues around the guideline’s breadth and depth and its relationship to the other guidelines in the ICH quality family....
- [Regulatory Transparency vs. Industry Flexibility at Issue for Starting Materials in ICH Q11](https://ipq.org/regulatory-transparency-vs-industry-flexibility-at-issue-for-starting-materials-in-ich-q11/) - The ICH Q11 Expert Working Group (EWG) has been wrestling with balancing regulatory transparency with industry flexibility in defining the starting material as it moves forward in drafting the guideline on drug substance development and manufacturing....
- [Regulatory Import of Non-critical Parameters Among Issues Under Debate at ICH Q8-10 Workshop](https://ipq.org/regulatory-import-of-non-critical-parameters-among-issues-under-debate-at-ich-q8-10-workshop-in-estonia/) - The expectations for non-critical parameters in communicating with regulators on process design, control and change management drew significant attention at the ICH Quality Implementation Working Group (IWG) training workshop in Tallinn, Estonia in early June....
- [Generics Industry Outreach Urged at Q8-10 Implementation Workshop in Estonia](https://ipq.org/generics-industry-outreach-urged-at-q8-10-implementation-workshop-in-estonia/) - The importance of pulling the generics industry more directly into the QbD/ICH Q8-10 implementation process was stressed by key regulatory and industry officials during the concluding session at the ICH Quality Implementation Working Group (IWG) workshop in Tallinn, Estonia in early June. The workshop was sponsored by the associations PDA and ISPE....
- [Senior Management Involvement is Critical for ICH Q8-10 Implementation Success, Regulators Affirm](https://ipq.org/senior-management-involvement-is-critical-for-ich-q8-10-implementation-success-regulators-affirm/) - Regulators from all three ICH regions participating in a Q8-10 training workshop in Estonia in early June stressed the need for pharma company senior management support of quality system principles – pointing to the improved quality, compliance, communication and relationships with regulators that result from this commitment....
- [ICH Q8-10 IWG Making Adjustments Based on Estonia Workshop and Follow-up ICH Meeting](https://ipq.org/ich-q8-10-iwg-making-adjustments-based-on-estonia-workshop-and-follow-up-ich-meeting/) - The ICH Q8-10 Implementation Working Group (IWG) has concluded, based on its industry/regulator workshop in Tallinn, Estonia in early June and the IWG’s internal meeting the following week, that refinement of the training model used in the workshop, additional Q&As, and further evaluation of the other ICH quality guidelines for inclusion of Q8-10 principles are needed....
- [Genzyme Allston Plant Resumes Normal Operations Although Shortages Continue](https://ipq.org/genzyme-allston-plant-resumes-normal-operations-although-shortages-continue/) - In a June 29 update, Genzyme clarified its current production status and the impact remediation efforts are having on its ability to release product and supply the market....
- [Consulting Firms Are Busy in Wake of Stronger FDA Enforcement, Lachman’s Sturgeon Reports](https://ipq.org/consulting-firms-are-busy-in-wake-of-stronger-fda-enforcement-lachmans-sturgeon-reports/) - Heightened scrutiny of drug manufacturers by FDA has led to an increase in warning letters, injunctions, and import alerts, and in turn has significantly increased the demand for consulting services, Lachman Consultants’ President Roy Sturgeon told the participants in an investor “conference call” sponsored by New York-based Lazard Capital Markets on June 22....
- [FDA Tabling Public Biosimilar Discussions While Digesting Complexities of New Legislation](https://ipq.org/fda-tabling-biosimilar-discussions-while-digesting-complexities-of-new-legislation/) - FDA speakers at recent conferences have been open about their inability to discuss biosimilar issues at this time, while they digest the implications of the recently-passed Patient Protection and Affordable Care Act (PPACA)....
- [Pfizer Finds QbD a “Large Value Proposition,” VP Migliaccio Tells DIA Annual Meeting](https://ipq.org/pfizer-finds-qbd-a-large-value-proposition-vp-migliaccio-tells-dia-annual-meeting/) - Pfizer’s assessment of its data on the impact of implementing quality by design indicates that QbD is “a very large value proposition,” Global Manufacturing Network Performance Senior VP Gerald Migliaccio reported at DIA’s Annual Meeting in Washington, D.C. on June 16....
- [FDA Wants to See More Transparency Between Drug Companies and Contractors on Sponsor’s Application and Contractor’s GMP Status](https://ipq.org/fda-wants-to-see-more-transparency-between-drug-companies-and-contractors-on-sponsors-application-and-contractors-gmp-status/) - FDA investigators will be looking for more transparency between a sponsor and its contract sites regarding the sponsor’s drug application commitments and the contractor's plant-wide GMP status, FDA Cincinnati District Investigator and Preapproval Manager Kathleen Culver emphasized at a Global Outsourcing Conference at Xavier University on June 14....
- [EU Moving to Tighten GMP Requirements on Outsourcing and Supply Chain Control](https://ipq.org/eu-moving-to-tighten-gmp-requirements-on-outsourcing-and-supply-chain-control/) - Changes to the EU regulations that govern technical agreements, outsourced activities, active pharmaceutical ingredient (API) supply chains, and the storage and transit of medicines are in progress and expected to be released soon for public consultation....
- [WHO Updating Sterile Processing Guide to Align with US, EU, and Japan](https://ipq.org/who-updating-sterile-processing-guide-to-align-with-us-eu-and-japan/) - The World Health Organization (WHO) is updating its Annex 4 “Good Manufacturing Practices for Sterile Pharmaceutical Products,” replacing its 1999 version of that document to align with more recent guidance issued by the three ICH countries....
- [USP Seeks Help from Industry for its Monograph Modernization Effort](https://ipq.org/usp-seeks-help-from-industry-for-its-monograph-modernization-effort/) - The US Pharmacopeia (USP) is seeking help from drug manufacturers in its effort to update monographs for small molecules and excipients that use outdated technology, have safety/environmental concerns, or are missing key aspects. The focus for “modernization” of excipient monographs will be to replace relatively non-specific identification procedures with more specific tests such as infrared spectroscopy....
- [Novo Nordisk QbD Initiative Gaining Traction Faster Than Anticipated](https://ipq.org/novo-nordisk-qbd-initiative-gaining-traction-faster-than-anticipated/) - Novo Nordisk’s broad-reaching quality-by-design (QbD) initiative for protein development is gaining traction faster than the company had anticipated, fueled by buy-in from top management and the production department....
- [EU and Cambodia Take Steps to Fight Counterfeit Drugs](https://ipq.org/eu-and-cambodia-take-steps-to-fight-counterfeit-drugs/) - The EU and Cambodia have recently taken additional steps in the fight against counterfeit drugs: the Council of Europe (EC) updated the EU draft guidance on “falsified medicines,” and Cambodia initiated a crackdown on illegal pharmacies operating in their country.....
- [Congressional Investigation into J&J Recall Actions Widens to Include Contractors](https://ipq.org/congressional-investigation-into-jj-recall-actions-widens-to-include-contractors/) - Contract firms identified as helping Johnson & Johnson with what House Oversight committee chair Edolphus Towns (D-NY) has referred to as a “phantom recall” have now received letters from the committee from asking them to detail their roles in the action....
- [House Committee Chair Towns Asks J&J’s CEO for Detailed Information on McNeil Recall Actions](https://ipq.org/house-committee-chair-towns-asks-jjs-ceo-for-detailed-information-on-mcneil-recall-actions/) - House Committee on Oversight and Government Reform Chair Edolphus Towns (D-NY) has sent a letter to Johnson & Johnson (J&J) CEO William Weldon requesting additional specific information on a market action taken regarding one of its Motrin products last year. Information requested on what Towns terms a “phantom recall” includes the names of J&J employees who were involved in making the decision to pursue this action, names of the contractors involved, and all records related to the action....
- [FDA Proposing More Transparency on Inspection Findings, Recalls, and Drug Filings](https://ipq.org/fda-proposing-more-transparency-on-inspection-findings-recalls-and-drug-filings/) - An FDA task force released on May 19 a set of transparency principles for public comment which propose to change what GMP and CMC documents and information are available to the public and with what timing. The proposals include making more information available more rapidly regarding GMP inspections, enforcement activities, and investigational, marketing and supplemental filings....
- [House Committee Hears from J&J and FDA on McNeil’s Recall and Compliance Problems](https://ipq.org/house-committee-hears-from-jj-and-fda-on-mcneils-recalls-and-compliance-problems/) - The House Committee on Oversight and Government Reform brought Johnson & Johnson (J&J) and FDA to the table on May 27 to take a hard look at J&J’s recent recall and GMP compliance problems. In focus at the Congressional hearing were J&J’s actions – including what was referred to by the committee as a “phantom recall” – FDA inspection findings, and possible further GMP and criminal investigations....
- [Teva Discontinues Propofol in the Wake of FDA GMP Concerns and Lawsuit Verdict](https://ipq.org/teva-discontinues-propofol-in-the-wake-of-fda-gmp-concerns-and-lawsuit-verdict/) - In the wake of GMP concerns resulting in an FDA warning letter and recall, and a clinical practice-related lawsuit verdict involving heavy punitive damages, Teva announced on May 28 that it will discontinue manufacturing its generic injectable emulsion version of the sedative propofol....
- [Genzyme Consent Decree Results in $175 Million Fine, Drug Shortages Will Continue](https://ipq.org/genzyme-consent-decree-results-in-175-million-fine-drug-shortages-will-continue/) - Genzyme’s consent decree for GMP violations at its Allston, Massachucetts plant will require it to pay a $175 million “disgorgement fee” and bring the plant back into compliance with applicable regulations within a specified time frame, during which time shortages of several of its drugs will continue. The consent decree was filed in the U.S. District Court for the District of Massachusetts on May 24, 2010, and is subject to court approval....
- [European Trade Associations Step Up to the Plate on Drug Counterfeiting](https://ipq.org/european-trade-associations-step-up-to-the-plate-on-drug-counterfeiting/) - Two trade associations in Europe, through separate but related efforts, are advancing the dialogue on preventing counterfeit medicines from entering the legitimate drug supply chain: one by publishing a set of guiding principles to call attention to the issue; the other by successfully executing a pilot program on security of drug products in the supply chain....
- [FDA to Partner with State Agencies on Recalls and Regulatory Actions](https://ipq.org/fda-to-partner-with-state-agencies-on-recalls-and-regulatory-actions/) - FDA is developing national procedures for engaging state agencies in the follow-up to recalls and moving toward partnerships with state agencies to allow the use of state data to support other regulatory actions....
- [Particulates in Biotech Products: Standard Setting Effort Gaining Traction](https://ipq.org/particulates-in-biotech-products-standard-setting-effort-gaining-traction/) - Visible and sub-visible particles in parenteral products and the need for developing measurement standards is drawing attention from regulators and industry at biotech conferences....
- [Process Modeling in Focus for EU and US Reviewers](https://ipq.org/process-modeling-in-focus-for-eu-and-us-reviewers/) - The understanding of the potential uses and value of models in facilitating manufacturers’ development efforts and helping regulators understand their complex processes is growing....
- [FDA Views Clinical Linkages as Key QbD Implementation Gap](https://ipq.org/fda-views-clinical-linkages-as-key-qbd-implementation-gap/) - As quality-by-design (QbD) implementation progresses, FDA is becoming aware of the scientific gaps that still need to be filled in. One area in particular that has generated considerable attention among industry and regulators is “understanding the link between what that product is and how it works in the patient – that is, integrating the field of biopharmaceutics into QbD,” ONDQA Acting Deputy Director Christine Moore stressed at a recent conference.
- [FDA Touting Benefits of Continuous Manufacturing](https://ipq.org/fda-touting-benefits-of-continuous-manufacturing/) - One area, in particular, that FDA is focusing on as a significant opportunity for advancing its quality-by-design objectives is continuous manufacturing. CDER officials’ have been highlighting their interest in continuous manufacturing at recent conferences, noting the recent progress that has been made in converting the concept into practice....
- [ICH Moves to Estonia in June: Heavy Metals, APIs, Implementing Q8-10 in Focus](https://ipq.org/ich-moves-to-estonia-in-june-heavy-metals-apis-implementing-q8-10-in-focus/) - ICH is gathering in Tallinn, Estonia in early June to focus on advancing its quality guidance harmonization initiatives on heavy metals (Q3D), drug substances (Q11), pharmacopeial methods (Q4B), and ICH Q8-10 implementation....
- [Human Factors/Usability Gaining Prominence in Combination Product Review](https://ipq.org/human-factorsusability-gaining-prominence-in-combination-product-review/) - Human factors/usability analysis is gaining prominence in the dialogue between combination product manufacturers and regulators. At issue is an effective pathway for companies to follow in conducting and submitting the analysis and for regulators to follow in reviewing it....
- [Better Human Factors Analysis is Driving New Combination Product Technologies Designed to Reduce User Errors](https://ipq.org/better-human-factors-analysis-is-driving-new-combination-product-technologies-to-reduce-user-errors/) - Multi-sensory training tools and design features for auto-injectors, including audio instructions, are among the error-reduction technologies being driven by better human factors (HF) analysis in the drug/device combination product arena....
- [FDA-Wide Effort Underway to Clarify and Harmonize CAPA Definitions in Line with New GHTF Guide](https://ipq.org/fda-wide-effort-underway-to-clarify-and-harmonize-capa-definitions-in-line-with-new-ghtf-guide/) - FDA Center for Devices and Radiological Health (CDRH) GMP expert Kimberly Trautman is spearheading an effort to clean up and harmonize the definitions around corrective and preventive action (CAPA) across the agency in line with a Global Harmonization Task Force (GHTF) guideline on CAPA that is nearing release....
- [Europe is Assessing Challenges of Implementing Combination Product Regulatory Changes; Attention on CPs Increasing Globally](https://ipq.org/europe-is-assessing-challenges-of-implementing-combination-product-regulatory-changes-attention-on-cps-increasing-globally/) - The stress on the resources and expertise of the European notified bodies in taking on the assessment of the device component of higher-risk drug/device combination products is among the significant challenges the EU faces as it enters the implementation phase of its new medical device and in vitro diagnostic regulations (MDR/IVDR). The new regulations, which
- [Contracting Relationships and Quality Agreements Are High on FDA's Inspection Radar Screen](https://ipq.org/godwin/) - The Office of Compliance (OC) at FDA’s Center for Drug Evaluation and Research (CDER) is making clear in its public presentations, compliance actions, and guidance to industry that the relationship between contract manufacturers and product owners – and the quality agreements they have in place to facilitate this relationship – will be a key focal
- [Improving Communications on Drug/Device Combination Product Quality and Performance is an Increasing Priority in the US and Europe](https://ipq.org/improving-communications-on-drugdevice-combination-product-quality-and-performance-is-an-increasing-priority-in-the-us-and-europe/) - Industry and regulators in the US and Europe are wrestling with how best to interpret and communicate drug quality-by-design (QbD) concepts, device design controls (DC) and overall final product risk management in the drug/biologic/device combination product context. At issue are the CMC development, control strategy, and submission requirements for bringing combination products (CPs) to the
- [EMA’s Draft Guideline on Drug-Device Combinations Sheds Needed Light on Expectations for Device Assessment](https://ipq.org/emas-draft-guideline-on-drug-device-combinations-sheds-needed-light-on-expectations-for-device-assessment/) - EMA’s draft guideline on quality requirements for drug-device combination (DDC) products provides a template for the new concept of the notified body opinion (NBOp), intended to help ensure a consistent interpretation by individual assessors, notified bodies, and industry.
- [Asian Agencies Report on Progress in Addressing Emerging Regulatory Challenges at CASSS Biotech CMC Strategy Forum in Japan](https://ipq.org/asian-agencies-report-on-progress-in-addressing-emerging-quality-regulatory-challenges-at-casss-cmc-strategy-forum-in-japan/) - Asian medicines agencies are joining those in the US and Europe in seeking to address the emerging regulatory challenges posed by: ● new classes of products such as cell-based regenerative medicines and engineered antibodies ● accelerated approval pathways ● biosimilars ● international convergence, and ● validation lifecycle management....
- [New CMC Submission Approach Needed to Foster Transparency and Continuous Improvement, PhRMA Team Says; Embedding Control Strategy as Regulatory Commitment in QOS Proposed](https://ipq.org/new-cmc-submission-approach-needed-to-foster-transparency-and-continuous-improvement-phrma-team-says-embedding-control-strategy-as-regulatory-commitment-in-qos-proposed/) - A working group of prominent CMC experts across the member companies of the Pharmaceutical Research and Manufacturers of America (PhRMA) has formulated a proposal for a more performance and risk-based regulatory approach to CMC submissions that would better accommodate post-approval manufacturing and control improvements....
- [Guides on FDA’s Generic Drug Review Process Continue Apace in July; EU Pilot Pursues Generic Drug Review Streamlining Internationally](https://ipq.org/guides-on-fdas-generic-drug-review-process-continue-apace-in-july-eu-pilot-pursues-generic-drug-review-streamlining-internationally/) - The efforts by the Office of Generic Drugs (OGD) to clarify and streamline the Abbreviated New Drug Application (ANDA) process and facilitate the implementation of the Generic Drug User Fee Act (GDUFA) continued apace in mid-July with the release of draft guidances on post-approval supplements and easily correctable deficiencies. Comments on the drafts are due by mid-September....
- [FDA and EMA Finalize Guidances to Help in Postapproval Change Management](https://ipq.org/fda-and-ema-finalize-guidances-to-help-in-postapproval-change-management/) - FDA and EMA have issued final guidances intended to help industry better understand and manage the regulatory expectations for postapproval CMC changes....
- [Industry Proposals for Addressing Post-Approval Change Burdens Include Harmonizing on Commitments and Classifications](https://ipq.org/industry-proposals-for-addressing-post-approval-change-burdens-include-harmonizing-on-commitments-and-classifications/) - Biopharmaceutical firms are calling for a global effort to decrease their heavy post-approval change filing burdens that would clarify and harmonize change classification and submission requirements on a risk-based foundation....
- [FDA Draft Guidance on Syringe Connection Problems Reemphasizes Need for Early Agency/Sponsor Dialogue on Combo Products; Postapproval Change Guide Issued](https://ipq.org/fda-draft-guidance-on-syringe-connection-problems-reemphasizes-need-for-early-agencysponsor-dialogue-on-combo-products-postapproval-change-guide-issued/) - A new draft guidance from FDA on glass syringe connection problems, which have been associated with serious adverse events and quality issues over the past few years, reemphasizes the need for early dialogue between combination product sponsors and the agency to avoid potential design and development pitfalls....
- [FDA’s Center for Drugs Redoubles Effort to Achieve 21st Century Quality Vision and Foster Continuous Process Improvement](https://ipq.org/fdas-center-for-drugs-redoubles-effort-to-achieve-21st-century-quality-vision-and-foster-continuous-process-improvement/) - FDA’s Center for Drug Evaluation and Research (CDER) is wrestling with how to reshape its quality regulatory system to foster rather than impede continuous improvement across the lifecycle of a process....
- [International Dialogue Should Focus on Harmonizing Control Strategy Filings and CMC Change Requirements, Moheb Nasr’s Industry Experience Confirms](https://ipq.org/international-dialogue-should-focus-on-harmonized-control-strategy-filings-and-cmc-change-requirements-moheb-nasrs-industry-experience-confirms/) - Moheb Nasr’s recent experience as a leader of global CMC strategy for GlaxoSmithKline (GSK) has reinforced his conviction that the international quality regulatory dialogue should focus on clarifying and harmonizing the filing expectations for the control strategy as a lynchpin in the advancement of the quality-by-design/continuous improvement paradigm....
- [EMA’s Biosimilar Quality Guideline Redraft Sharpens Focus on Target Profiles and Lifecycle Changes of Reference Product](https://ipq.org/emas-biosimilar-quality-guideline-redraft-sharpens-focus-on-target-profiles-and-lifecycle-changes-of-reference-product/) - The new draft of EMA’s biosimilars quality guideline includes a heightened focus on understanding the quality target product profile (QTPP) of the reference product and the changes that have occurred to the quality attributes over the reference product’s lifecycle....
- [Divergent Global Change Filing Requirements Present Continuous Improvement Roadblocks, Experts Stress at ICH Q10 Conference](https://ipq.org/divergent-global-change-filing-requirements-present-continuous-improvement-roadblocks-experts-stress-at-ich-q10-conference/) - The power of the advancing pharmaceutical quality systems to manage change and drive continuous improvement is being hampered by the disharmony and inflexibility of the CMC filing requirements across the globe, prominent industry and regulatory experts reemphasized at a quality systems/ICH Q10 conference in Arlington, Virginia in early October....
- [Europe Asks for Stakeholder Input in Refining and Harmonizing Its Variations Rules Across Member States](https://ipq.org/europe-asks-for-stakeholder-input-in-refining-and-harmonizing-its-variations-rules-across-member-states/) - The European Commission (EC) has asked stakeholders to weigh in on its effort to further rationalize and harmonize the handling of variation filings across Europe....
- [Emergency Preparations Draw Heightened Industry and Regulator Attention as Natural and Man-Made Disasters Proliferate](https://ipq.org/emergency-preparations-draw-heightened-industry-and-regulator-attention-as-natural-and-man-made-disasters-proliferate/) - Extreme weather events, political instability, and economic disruptions are prompting the pharmaceutical community to heighten its focus on emergency preparedness. The following four-part report focuses on conference presentations and discussions during 2018 that have made a significant contribution to understanding the increasing challenges that industry and regulators are now facing around the world and how they are being addressed.
- [CMC Priorities of EFPIA’s European Biopharmaceutical Enterprises Include ADCs, Drug/Device Combos and Statistics](https://ipq.org/cmc-priorities-of-efpias-european-biopharmaceutical-enterprises-include-adcs-drug-device-combos-and-statistics/) - Drug device combinations (DDCs), antibody drug conjugates (ADCs), and the use of statistics in comparability assessments are among the current focal points of the European Biopharmaceutical Enterprises (EBE) in its efforts to identify and build consensus around the most pressing issues on the global regulatory agenda for biotech manufacturing and control.
- [FDA Inspection Findings Provide Additional Insight on CGMP Expectations for Combination Product Manufacturers](https://ipq.org/fda-inspection-findings-provide-additional-insight-on-cgmp-expectations-for-combination-product-manufacturers-2/) - The light being shed on the current GMP regulatory expectations for risk management and manufacturing control of combination products by FDA’s inspection engagement with pharma sponsors and their device partners has been a focal point at recent conferences in the US and Europe. Coming into relief in these conference discussions is the importance of the
- [FDA’s Office of Pharmaceutical Quality Advances Review/Inspection Integration](https://ipq.org/fdas-office-of-pharmaceutical-quality-continues-to-advance-reviewinspection-integration/) - FDA has put in place an umbrella “Concept of Operations” (ConOps) intended to support the Office of Pharmaceutical Quality (OPQ) in its efforts to ensure consistency, efficiency, and transparency in facility evaluations, inspections, and regulatory decision-making for marketing applications and create a more cohesive review/inspection process. During the summer, FDA released a ConOps white paper
- [Tension Between Quality Regulatory Paradigm and Pharma’s Innovation, Acceleration and Harmonization Imperatives in Spotlight](https://ipq.org/tension-between-quality-regulatory-paradigm-and-pharmas-innovation-acceleration-and-harmonization-imperatives-in-spotlight/) - Pfizer VP and Global CMC Head Roger Nosal is among prominent pharma thought leaders who are articulating the growing tension between the existing quality regulatory paradigm and the pharma imperatives of innovation, development/review acceleration, continuous improvement and regulatory harmonization. In a keynote presentation at the ISPE/FDA/PQRI Quality Manufacturing Conference in June in Alexandria, Virginia, Nosal
- [Impact of Accelerated Pathways on Method Development, Inter-Agency Collaboration Draw Regulator Discussion at Europe Biotech CMC Strategy Forum](https://ipq.org/impact-of-accelerated-pathways-on-method-development-and-inter-agency-collaboration-draws-regulator-panel-discussion-at-europe-biotech-cmc-strategy-forum/) - The impact of accelerated clearance pathways on the deployment of the analytical method toolbox for biotech products is among the issues drawing attention at industry/regulator conferences where the CMC challenges and the experience to date in accelerated review are being discussed. The compression of CMC timelines is putting additional stress on both companies and agency
- [Industry is Urging Latin American Agencies to Cooperate in Filling Lifecycle Management Regulatory Gaps for Biologics](https://ipq.org/fifarma-is-urging-latin-american-agencies-to-cooperate-in-filling-lifecycle-management-regulatory-gaps-for-biologics/) - The Latin America Federation of the Pharmaceutical Industry (FIFARMA) is advocating the need for the agencies in the region to extend the progress they have been making in regulating the approval process for biologics and cooperate on filling the regulatory gaps for their life-cycle management. As more biologics and biosimilars are approved in the region,
- [More Structured, Interactive Process To Drive Convergence in Latin America Advocated by Biotech Product Regulators and Industry at CMC Strategy Forum in Brasilia](https://ipq.org/more-structured-interactive-process-to-drive-convergence-in-latin-america-advocated-by-biotech-product-regulators-and-industry-at-cmc-strategy-forum-in-brasilia/) - The need for a more structured, interactive process to drive convergence and resource sharing among the regulatory agencies of Central and South America – potentially drawing on elements of the European model – was a dominant theme among the industry and regulator participants in the second annual CMC Strategy Forum Latin America held again in late August 2015 in Brazil’s capitol city Brasilia....
- [Global Change Protocols Proposed as Part of a More Standards-Based Approach to Regulating Life Cycle Management Internationally](https://ipq.org/global-change-protocols-proposed-as-part-of-a-more-standards-based-approach-to-regulating-life-cycle-management-internationally/) - Globally standardized change management protocols that would clarify the expectations internationally for implementing various types of manufacturing changes is among the proposals that are now on the table as industry and regulators explore what a more scientifically-based, efficient and harmonized quality regulatory paradigm could look like. The global change/comparability protocol (GCP) concept is being advocated
- [KASA and PQ/CMC Initiatives Gain Momentum in FDA’s Effort to Strengthen Quality Review Process](https://ipq.org/kasa-and-pq-cmc-initiatives-gain-momentum-in-fdas-effort-to-strengthen-quality-review-process/) - The efforts of FDA’s Office of Pharmaceutical Quality (OPQ) to standardize and streamline the CMC information in applications and how it is reviewed – initially for abbreviated new drug applications (ANDAs), and eventually for NDAs, and even biological license applications (BLAs) – is beginning to take concrete form.
- [IPQ Special Report -- September/October 2008 in Review](https://ipq.org/septemberoctober-2008/) - THE IMPACT OF QUALITY BY DESIGN ON BIOTECH REGULATION is growing. An FDA biotech QbD pilot and industry mock initiatives are getting underway that will build on the experience gained in the small molecule area. In the biotech context, the focus is shifting to the API and the challenges of defining critical quality attributes and design space for these complex molecules and processes.
- [IPQ Special Report -- July/August 2008 in Review](https://ipq.org/julyaugust-2008/) - THE IMPACT OF QUALITY SYSTEM PRINCIPLES ON INSPECTION PRAC­TICE IS EXPANDING in depth and breadth as EU and U.S. regulators seek to evolve their GMP guidance and compliance programs in line with the new ICH Q8­-10 paradigm. Reflcting Q10’s focus on the responsibilities of company management, inspectors will assess the level of management’s engagement with the quality system as a barometer of the system’s potential effectiveness.
- [IPQ Special Report -- May/June 2008 in Review](https://ipq.org/mayjune-2008/) - EXPANDED FDA RESOURCES AND ENFORCEMENT TOOLS ARE NEEDED to allow the agency to handle the challenges of overseeing a global marketplace, FDA and its stakeholders are telling a newly receptive U.S. Congress. In the wake of a series of serious health threats from quality breakdowns in the global supply chain, including deaths from adulterated heparin, Congress has been holding hearings to assess the implications and is developing legislation to help FDA catch up with its health protection mandates and complete its transition into an international regulatory authority.
- [IPQ Special Report -- March/April 2008 in Review](https://ipq.org/marchapril-2008/) - THE CHALLENGES IN CONTROLLING EXTRACTABLES AND LEACHABLES are driving drug and biologic manufacturers and their vendors to explore new ways of comparing experience and sharing information. As product, process, packaging and delivery materials and systems evolve and their interactions grow more complex, industry is looking for pathways to make the E&L evaluation process more efficient and effective, and new collaborations are being formed that reach across the supply chain and the product lifecycle.
- [IPQ Special Report -- January/February 2008 in Review](https://ipq.org/januaryfebruary-2008/) - THE REACH OF QUALITY SYSTEMS INTO THE SUPPLY CHAIN is drawing FDA attention as it looks for industry support in assuring ingredient quality in a complex global marketplace. As the regulator/industry relationship evolves, the agency may need to follow the lead of other regulators and review the audit reports and management reviews done by pharmaceutical manufacturers to make sure that their quality systems have the necessary self-assessment and response capabilities.
- [IPQ Special Report -- November/December 2007 in Review](https://ipq.org/novemberdecember-2007/) - THE EU IS ASSESSING ITS API QUALITY INITIATIVES to see how they are working in practice. An inspection survey of finished product manufacturers in the EU shows general compliance with the new expectations for supplier auditing and supply chain traceability. The European API industry, however, continues to lobby for more foreign inspection coverage to reflect the risks and level the GMP playing field. A new GMP database is part of an EMEA effort to strengthen compliance information sharing within and outside the EU.
- [IPQ Special Report -- July/August 2009 in Review](https://ipq.org/july-august-2009/) - THE PROCESS VALIDATION PARADIGM IS CHANGING and the implications for the way manufacturers control their process and regulators inspect them is being assessed. An FDA draft guideline has made clear that validation is a journey that extends across the process lifecycle from design to qualification to continued verification. Regulators will be expecting a more coherent and transparent approach to assuring process and product performance and managing the relevant knowledge.
- [IPQ Special Report -- November/December 2008 in Review](https://ipq.org/novemberdecember-2008/) - A GLOBALLY COORDINATED RESPONSE TO THE DRUG SUPPLY CHAIN PROBLEMS is being called for, as the realization takes hold among the various stakeholders that the only effective and affordable option is a unified effort. The call for collaborative action to better assure pharmaceutical ingredient quality and supply chain integrity has been forcefully sounded at recent regulator/ industry conferences, and momentum for an international consortium is rapidly building.
- [IPQ Monthly Update – October/November 2016 in Review](https://ipq.org/ipq-monthly-update-october-november-2016-in-review/) - In October and November, IPQ was focused heavily on the experience and learnings FDA has gained in the first five years of its biosimilars review program and the improvements that the agency and industry want to see happen with user fee help in moving forward. Also in focus in the international section of the Update are: ● advancing and harmonizing other aspects of the biotech product CMC review process, including accelerated pathways, and ● the current pressure and incentives to apply QRM to excipients.
- [IPQ Monthly Update – October / November 2017 in Review](https://ipq.org/ipq-monthly-update-october-november-2017-in-review-2/) - The first two stories in this issue explore the drug GMP compliance concerns that are most pressing on the FDA agenda as 2018 approaches. The third story returns to the intensifying global dialogue on the stresses industry and regulators are feeling as they wrestle with how to advance drug/biologic/device combination products in the context of regulatory structures and processes not very well adapted to handle them.
- [IPQ Monthly Update – August / September 2017 in Review](https://ipq.org/ipq-monthly-update-august-september-2017-in-review-2/) - The three stories in this issue provide insights from industry and agency thought leaders on how the pharma imperatives of innovation, acceleration and regulatory harmonization are putting pressure on the existing regulatory processes and quality systems and what industry and agencies such as FDA are doing to try to evolve them.
- [IPQ Monthly Update – December 2018 in Review](https://ipq.org/ipq-monthly-update-december-2018-in-review/) - The December issue provides updates on FDA/CDER’s Office of Generics Drugs and Office of Pharmaceutical Quality – what have been the key areas of focus over the past year and what the top priorities are going forward. The third story crosses the Atlantic to explore how Brexit is impacting the MHRA in the medicines arena and what the agency is doing to prepare for what may happen.
- [IPQ Monthly Update – November 2018 in Review](https://ipq.org/ipq-monthly-update-november-2018-in-review/) - The November Update provides a four-part report exploring the increasing challenges that industry and regulators around the world are now facing from climatic, demographic, political, and economic disruptions, and how they are being addressed. The four parts focus on: ● pharma company investment in disaster preparation ● FDA’s emergency response efforts ● the mega-trends putting supply chains at risk, and ● a panel discussion on Hurricane Maria’s impact.
- [IPQ Monthly Update – September/October 2018 in Review](https://ipq.org/ipq-monthly-update-september-october-2018-in-review/) - The first two stories in the September/October issue offer a wealth of insights from the compliance staff at FDA’s centers for drugs and biologics on their respective front-burner concerns and the actions they are taking. Both the CDER and CBER reviews include the office management perspective as well as what the compliance problems look like at the GMP facility inspection level. The third story shifts focus onto the learnings CDER’s Office of Biotechnology Products (OBP) has garnered from reviewing its BLA experience over the past two decades about how analytics and the regulatory expectations for them have evolved.
- [IPQ Monthly Update – July/August 2018 in Review](https://ipq.org/ipq-monthly-update-july-august-2018-in-review/) - The July/August issue begins with an exploration of how the ICH process has been evolving and the challenges and opportunities that are now presenting themselves. The second story then takes a deep dive into the intensive dialogue taking place on implementing ICH Q12 and its established conditions provisions, in particular. A series of three stories follows on the problems created by the different excipient regulatory frameworks and requirements around the world for both suppliers and users in their efforts to assure and improve the quality and availability of medicines.
- [IPQ Monthly Update – March/April 2018 in Review](https://ipq.org/ipq-monthly-update-marchapril-2018-in-review-2/) - Industry and regulators in the US and Europe are making a concerted effort to improve the depth and clarity of their communications on the manufacturing and control of drug/biologic/device combination products. The three stories in this issue explore the challenges of melding the drug and device regulatory worlds and what is being done to address them.
- [IPQ Monthly Update – January/February 2018 in Review](https://ipq.org/ipq-monthly-update-januaryfebruary-2018-in-review/) - During January and February, IPQ was focused heavily on the emerging challenges faced by regulators due to the rapidly increasing number of applications encompassing new products and therapies, technologies and processes. The three stories in this issue explore: ● how FDA’s generic drug review process is evolving with user fee support to address the increasing number and complexity of products emerging through it ● how CBER is responding to the wave of advanced therapies it is now facing, and ● a CDER/CBER view of the current biologic product CMC review landscape and the BLA challenges, accomplishments, and learnings.
- [IPQ Monthly Update – December 2017 in Review](https://ipq.org/ipq-monthly-update-december-2017-in-review-2/) - During the latter part of 2017, IPQ’s attention returned to the complex CMC challenges that the new, widely-diverse cell and gene therapies (CGTs) are presenting. In this Monthly Update, we share insights that have been offered at recent public forums by leading agency and industry experts on these challenges. [See IPQ’s March 2015 Monthly Update for our last in-depth review of CGT regulatory developments.]
- [IPQ Monthly Update – January 2019 in Review](https://ipq.org/ipq-monthly-update-january-2019-in-review/) - The January 2019 issue explores: ● the mission, process, and rapidly expanding project portfolio of the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) ● the significant efforts of the Gates Foundation, and its newly formed, biotech product-oriented Gates Medical Research Institute, to support CMC innovation that will increase developing world medicines access ● the issues that pharmacopoeial and registration divergences create globally, and the pathways for addressing them, and ● what it takes for biotech companies to avoid GMP compliance problems that can jeopardize application approvals and create manufacturing pitfalls.
- [IPQ Monthly Update – February 2019 in Review](https://ipq.org/ipq-monthly-update-february-2019-in-review/) - The February 2019 issue provides an in-depth review of: ● FDA’s increased focus on water systems as microbial contamination problems, particularly with B. cepacia, continue to surface around the world in non-sterile as well as sterile products and drive changes to the US and European pharmacopeias, and ● the role of the U.S. National Institute of Standards (NIST), in collaboration with a host of stakeholders, in creating a more robust standards infrastructure to support the complex development, manufacturing, and control challenges presented by rapidly evolving biotech products and processes.
- [Protecting the Public Health Trumps Explicit Legislative Mandate, FDA’s Chief Counsel Tells FDLI](https://ipq.org/protecting-the-public-health-trumps-explicit-legislative-mandate-fdas-chief-counsel-tells-fdli/) - FDA’s mandate to protect the public health requires making decisions in situations where there is no law explicitly empowering it to act, FDA Chief Counsel Ralph Tyler stressed at the Food and Drug Law Institute (FDLI) Annual Meeting in late April. In turn, Tyler explained that a key role for FDA lawyers is to be advocates for the agency in helping it reach its policy and enforcement goals in situations where waiting for approval from Congress does not allow a timely enough decision....
- [QbD is Changing the CMC Regulatory Landscape in the US and EU](https://ipq.org/ipq-may-2010-front-page/) - The May 2010 issue of International Pharmaceutical Quality (IPQ) provides an in-depth analysis of how quality by design and the new Q8-10 regulatory paradigm is transforming the CMC review process at the agency and international levels....
- [SFDA Releases Revised “Good Supply Practices” Guideline](https://ipq.org/sfda-releases-revised-good-supply-practices-guideline/) - China’s State Food and Drug Administration (SFDA) has released a revision of its good distribution practices guideline – which SFDA terms “good supply practices” (GSPs) – that will take effect at the beginning of June. Firms will have three years to come into full compliance. After that time, non-compliant firms will no longer be able
- [Russia Prefers Release Testing for Imported Drug Products to be Performed in Europe](https://ipq.org/russia-prefers-release-testing-for-imported-drug-products-to-be-performed-in-europe/) - Industry and EMA officials are reporting that for products marketed both in the EU and in Russia, Russian regulatory officials prefer release testing to be done in the EU. The issue of release testing for drug products going to Russia received attention during a panel discussion at a “European GMPs and the Role of the
- [New ISPE CEO Nancy Berg Announces ISPE Mission Refinements](https://ipq.org/new-ispe-ceo-nancy-berg-announces-ispe-mission-changes/) - At an ISPE conference on pharmaceutical supply chains in early June in Baltimore, Maryland, new ISPE President and CEO Nancy Berg explained to the attendees that the ISPE board at its meeting the previous weekend made some “subtle, but at the same time very significant changes in the mission of the society.” Here is what
- [Regulatory Focus on Good Distribution Practices Intensifying Across the Globe](https://ipq.org/regulatory-focus-on-good-distribution-practices-intensifying-across-the-globe/) - The focus on good distribution practices (GDPs) during regulatory inspections has increased dramatically recently, and the global regulatory community is working on a variety of fronts to refine GDP guidance, standards, regulations and the legislative framework to support them....
- [Immunogenic Potential of Aggregates Affirmed at Biotech CMC Forum](https://ipq.org/immunogenic-potential-of-aggregates-affirmed-at-biotech-cmc-strategy-forum/) - The clear potential for aggregates of subvisible particles (SVPs) to cause immunogenic responses in both animals and humans was affirmed at the biotech “CMC Strategy Forum” held in Washington, DC, in mid-January.
- [CMC/GMP Procedures and Interpretations Can Pose Challenges For Foreign Firms in ICH Member Japan](https://ipq.org/cmcgmp-procedures-and-interpretations-can-pose-challenges-for-foreign-firms-in-ich-member-japan/) - While ICH has had a strong harmonizing influence on Japan’s CMC review process, outside pharmaceutical firms continue to wrestle with understanding and implementing the interpretations and expectations around timeframes, formatting, level of detail and procedural requirements for licensing products in Japan....
- [Uncertainties in Subvisible Particulates Need to Be Understood, FDA Tells Biotech CMC Strategy Forum](https://ipq.org/uncertainties-in-subvisible-particulates-need-to-be-understood-fda-tells-biotech-cmc-strategy-forum/) - The uncertainties around subvisible particles (SVPs) may warrant their being controlled as a critical quality attribute, FDA Office of Biotechnology Products Division of Therapeutic Proteins (DTP) Deputy Director Barry Cherney stressed at a CASSS/FDA CMC Strategy Forum in Washington, D.C in January....
- [USP Upgrading Bioassay Coverage; FDA Weighs In on Bioassays at AAPS’ National Biotech Meeting](https://ipq.org/usp-upgrading-bioassay-coverage-fda-weighs-in-on-bioassays-at-aaps-national-biotech-meeting-2/) - The US Pharmacopeia (USP) is upgrading its coverage related to bioassays to keep pace with the evolving science and technology. In its July/August Pharmacopeial Forum, USP is proposing revisions for public comment to General Chapters , , and , which address the design, validation, and analysis of bioassays respectively....
- [FDA Seeing Wide Variation in Drug Application Manufacturing Submissions, Causing Approval Delays](https://ipq.org/fda-seeing-wide-variation-in-drug-application-manufacturing-submissions-causing-approval-delays/) - Manufacturing information that is inaccurate, incomplete, inconsistent, or in the wrong section in new and abbreviated new drug applications (NDAs/ANDAs) as well as facilities not being ready for an inspection continue to be problem areas causing delays in application approvals, Center for Drug Evaluation and Research (CDER) officials are reporting....
- [Facility Listing Errors and Missing Development Data Draw Withhold Recommendations From FDA’s NJ District](https://ipq.org/facility-listing-errors-and-missing-development-data-draw-withhold-recommendations-from-fdas-nj-district/) - Facility listing errors on the application and a lack of availability of development data source documents during pre-approval inspections are causing the New Jersey District to recommend withholding drug approvals, its investigations branch director Myriam Sosa told DIA’s June Annual Meeting....
- [Understanding Biosimilar/Biobetter Approval Pathways and Differences Key to Success, Merck Exec Says](https://ipq.org/understanding-biosimilarbiobetter-approval-pathways-and-differences-key-to-success-merck-exec-says/) - Success for both biotech innovator companies and biosimilar manufacturers under the new health care legislation will require working with FDA to optimize the regulatory approval pathways and understanding the key differences between biosimilars and biobetters, a Merck executive maintained in a recent interview....
- [EMA Issues Q&A on Supply Chain Traceability to Support Revised Medicinal Gas Annex](https://ipq.org/ema-issues-qa-on-supply-chain-traceability-to-support-revised-medicinal-gas-annex/) - EMA recently issued a Q&A addressing supply chain traceability expectations for medicinal gases to support the revision to Annex 6 to the EU GMP Guide. The revised annex on “The Manufacture of Medicinal Gases” was adopted by the European Commission at the end of January and became effective at the beginning of August....
- [FDA Releases Guideline on Animal Drug Substance CMC Filings in CTD Format](https://ipq.org/fda-releases-guideline-on-animal-drug-cmc-filings-in-ctd-format/) - FDA’s Center for Veterinary Medicine (CVM) has released a guideline on how to file drug substance CMC information for new and abbreviated new animal drug applications (NADAs/ANADAs) in the Common Technical Document (CTD) format. The CMC guideline was released as a final version rather than as a draft for comment....
- [Biosimilar Products, Guidelines and Requests for Scientific Advice Continue to Increase in EU](https://ipq.org/biosimilar-products-guidelines-and-requests-for-scientific-advice-continue-to-increase-in-eu/) - The European Medicines Agency (EMA) portfolio of approved biosimilar products and guidelines and the related requests for scientific advice continue to expand, with interest increasing in particular in monoclonal antibodies....
- [Increased EMA/Industry Dialogue Needed to Address Upcoming Biopharm Regulatory Challenges, Retiring Quality Director Purves Says](https://ipq.org/increased-emaindustry-dialogue-needed-to-address-upcoming-biopharm-regulatory-challenges-retiring-quality-director-purves-says/) - The biopharmaceutical regulatory challenges confronting the EMA over the next decade – from biosimilars, advanced therapies, personalized medicine and transgenics to variations and quality by design – will require close industry/regulator dialogue and new communication channels, recently retired EMA Quality of Medicines Head John Purves stressed at CASSS’ European CMC Strategy Forum in Vienna in late May....
- [New Oral Formulation Approaches Are Accelerating Product Movement Into the Clinic](https://ipq.org/new-oral-formulation-approaches-are-accelerating-product-movement-into-the-clinic/) - The use of micro-dosing in clinical formulations is increasing as firms wrestle with how to get their new oral drug products to the clinic as quickly as possible with the fewest regulatory hurdles....
- [FDA Draft Guidance Promotes the Use of QbD to Help Solve Residual Drug Problems in Transdermal Delivery Systems](https://ipq.org/fda-draft-guidance-promotes-the-use-of-qbd-to-help-solve-residual-drug-problems-in-transdermal-delivery-systems/) - FDA’s new draft guidance on transdermal and related drug delivery systems discusses the agency’s concerns with the residual drug left in the delivery systems after the intended use period and recommends manufacturers use quality-by-design (QbD) principles to minimize the problem for both new and existing products....
- [Warning Letters to Two Overseas Sterile Ophthalmic Manufacturers Cite Similar Microbial Control Practices](https://ipq.org/warning-letters-to-two-overseas-sterile-ophthalmic-manufacturers-cite-similar-microbial-control-practices/) - FDA has issued warning letters to two foreign-based aseptic ophthalmic firms citing a strikingly similar litany of problems with procedures and practices designed to prevent microbial contamination....
- [Gemfibrozil Manufacturing Problems at Sun’s NJ Facility Among Issues Prompting FDA Warning Letter](https://ipq.org/gemfibrozil-manufacturing-problems-at-suns-nj-facility-among-issues-prompting-fda-warning-letter/) - Gemfibrozil manufacturing problems resulting in imploding sample bottles and unknown impurities and how they were responded to were central concerns highlighted in an FDA warning letter to Sun Pharmaceuticals in late August regarding inspection findings at the Indian generic drug company’s Cranbury, New Jersey facility....
- [FDA and EMA Extend Confidentiality Agreement “Indefinitely”](https://ipq.org/fda-and-ema-extend-confidentiality-agreement-indefinitely/) - FDA and the European Medicines Agency (EMA) are extending their confidentiality agreement covering information-sharing on human and veterinary medicine products “indefinitely without the need for further renewal” due to positive experiences by both agencies during the seven years the agreement has been in place....
- [The Combination of GMP & Unapproved Drug Problems Continues to Prompt FDA Warning Letters](https://ipq.org/the-combination-of-gmp-unapproved-drug-problems-continues-to-prompt-fda-warning-letters/) - Warning letters to a pair of over-the-counter (OTC) drug manufacturers just released by FDA indicate that the marketing of unapproved drugs continues to escalate the agency’s response when GMP problems are found....
- [MHRA Inspectors Will Look For “Risk Registers,” SOPs and Periodic Review in Quality Risk Management Systems](https://ipq.org/mhra-inspectors-will-look-for-risk-registers-sops-and-periodic-review-in-quality-risk-management-systems/) - British inspectors when inspecting drug manufacturers will be looking for a “risk register” and a defined document management control system including periodic reviews of risk management assessments, according to a “frequently asked questions” (FAQ) document recently-published by the UK's Medicines and Healthcare products Regulatory Agency (MHRA)....
- [FDA Could be a PIC/S Member by Year’s End](https://ipq.org/fda-could-be-a-pics-member-by-years-end/) - The evaluation committee for the Pharmaceutical Inspection Cooperation Scheme (PIC/S) is expected to recommend FDA’s acceptance into the 37-member organization at the next PIC/S meeting in Kuala Lumpur, Malaysia in November. Membership accession could follow by year’s end.
- [Temperature and Storage Conditions Top the List of Major/Critical Deficiencies in MHRA GDP Inspections](https://ipq.org/temperature-and-storage-conditions-top-the-list-of-majorcritical-deficiencies-in-mhra-gdp-inspections/) - Temperature and storage conditions were the most common Good Distribution Practice (GDP) deficiencies ranked “major” and “critical” by the UK Medicines and Healthcare products Regulatory Agency (MHRA) during inspections conducted from January to June of 2010....
- [FDA Investigator Training Reflects Changing Technology, Regulatory Approaches and New Hire Profile](https://ipq.org/fda-investigator-training-reflects-changing-technology-regulatory-approaches-and-new-hire-profile/) - FDA’s Office of Regulatory Affairs (ORA) is adapting its training to reflect changing technologies and regulatory approaches, and a bolus of new investigators with divergent experience....
- [Ongoing FDA Concerns with Procedure Compliance, Media Fill Practices and Environmental Excursions at BMS’ Manati, PR Plant Draw Warning Letter](https://ipq.org/ongoing-fda-concerns-with-procedure-compliance-media-fill-practices-and-environmental-excursions-at-bms-manati-pr-plant-draw-warning-letter/) - Findings by FDA during a mid-March inspection at Bristol-Myers Squibb’s (BMS) injectable operations in Manati, Puerto Rico of problems with procedure and media fill compliance – previously noted in 2005 and 2009 inspections – contributed to a late-August warning letter to the firm....
- [China’s SFDA Moving Toward Expanding Supply Chain Auditing and Filing Requirements](https://ipq.org/chinas-sfda-moving-toward-expanding-supply-chain-auditing-and-filing-requirements/) - China’s State Food and Drug Administration (SFDA) has released a draft of a new regulation that would significantly expand the supply chain auditing and filing requirements for manufacturers of active pharmaceutical ingredients (APIs) and packaging as well as drug products....
- [Australia’s TGA Publishes Updated Draft Guidance on Clearance of Products Manufactured Overseas](https://ipq.org/australias-tga-publishes-updated-draft-guidance-on-clearance-of-products-manufactured-overseas/) - TGA has released for comment a draft guideline that clarifies its requirements for GMP compliance by overseas manufacturers and further harmonizes those requirements with other international regulatory bodies....
- [FDA Wants More Transparency on Drug Recall Data and Causes](https://ipq.org/fda-wants-more-transparency-on-drug-recall-data-and-causes/) - FDA is looking to create more transparency around the data it collects on product recalls and their underlying causes....
- [Laboratory Control Issues Prominent in Recent Warning Letters to Four Overseas Firms](https://ipq.org/laboratory-control-issues-prominent-in-recent-warning-letters-to-four-overseas-firms/) - Laboratory control problems are prominent in a bolus of FDA drug GMP warning letters recently issued to companies in Asia and Europe....
- [Regulatory Approach to Manufacturing and Control of Cell/Gene Therapies Draws International Discussion](https://ipq.org/regulatory-approach-to-manufacturing-and-control-of-cellgene-therapies-draws-international-discussion/) - Regulators around the world have been taking the opportunity at recent international forums to benchmark on their respective efforts to create a viable framework for regulating the manufacturing and control of cell/gene/tissue therapies and to consider harmonization possibilities....
- [Potency Assay Challenges and Pathways for Cell and Gene Therapies Explored by Industry/Regulator Expert Panel](https://ipq.org/potency-assay-challenges-and-pathways-for-cell-and-gene-therapies-explored-by-industryregulator-expert-panel/) - Putting in place a QC-friendly potency assay to support commercialization of cell and gene therapy (CGT) products will require an iterative process that needs to be thought out early in development with regulator input, experts involved are advising....
- [Novartis Exploring Boundaries of Biotech Manufacturing and Control to Make Cell and Gene Therapy Commercialization a Reality](https://ipq.org/novartis-exploring-boundaries-of-biotech-manufacturing-and-control-to-make-cell-and-gene-therapy-commercialization-a-reality/) - Novartis is among the major global pharmaceutical companies that are taking a hard look at how the advancements in biotech manufacturing and control technology and systems can be adapted to help make cell and gene therapy (CGT) commercialization a reality....
- [Sanofi is Coordinating the Lifecycle Management of its Automation Systems to Head Off Manufacturing Breakdowns](https://ipq.org/sanofi-is-prioritizing-implementation-of-coordinated-lifecycle-management-processes-for-automation-systems-to-head-off-manufacturing-breakdowns/) - Sanofi is focusing more attention on coordinating the lifecycle management of its automation systems to head off the major threats to the continuity of manufacturing operations that ensue from not having a well thought-out planning process in place....
- [Industry Experts Shed Hard Light on Negative Impacts of Current Complex Post-Approval Change Regulatory Situation Globally, with ICH Q12 in View](https://ipq.org/industry-experts-shed-hard-light-on-negative-impacts-of-current-complex-post-approval-change-regulatory-situation-globally-with-ich-q12-in-view/) - The vast resource drain that the current post-approval change regulatory situation globally is creating on both industry and regulators is in sharp relief at public venues where the future of pharmaceutical quality regulation is being discussed. With the ICH Q12 effort opening the door on a more efficient and improvement-friendly post-approval change paradigm, hard light
- [Novel Excipient Enables Successful MannKind Inhaled Insulin Formulation; Formulation/Device Inhalation Technology Offers Platform Potential](https://ipq.org/novel-excipient-enables-successful-mannkind-inhaled-insulin-formulation-formulationdevice-inhalation-technology-offers-platform-potential/) - The development, testing, and use of a novel excipient as part of its formulation enabled MannKind to develop a viable inhaled insulin product after other firms’ insulin inhalation projects had not been successful....
- [FDA CMC Reviewer Recommendations for New Drug Approval Depend on Control Strategy Understanding, CDER is Stressing](https://ipq.org/fda-cmc-reviewer-recommendations-for-new-drug-approval-depend-on-control-strategy-understanding-cder-is-stressing/) - CDER is stressing that a clear picture of the control strategy is pivotal for CMC reviewers to make a meaningful application approval recommendation and meet the shrinking timelines under which they are operating....
- [ICH’s API Coverage Deepening with a Newly Released Q&A on Q7 and a Q11 Q&A Project on Starting Materials Underway](https://ipq.org/ichs-api-coverage-deepening-with-a-newly-released-qa-on-q7-and-a-q11-qa-project-on-starting-materials-underway/) - A newly released Q&A from ICH on its active pharmaceutical ingredient (API) GMP guideline Q7 and another Q&A being prepared on the more recently issued API development and submission guideline Q11 are intended to address issues that have surfaced in implementing the two guidelines and drive more uniform interpretation across industry and regulators worldwide....
- [FDA’s “New Inspection Protocol Project” will Impact How Inspections Are Planned, Conducted, Reported On, and Assessed and Offers a Potential Global Model](https://ipq.org/fdas-new-inspection-protocol-project-will-impact-how-inspections-are-planned-conducted-reported-on-and-assessed-and-offers-a-potential-global-model/) - FDA’s Center for Drug Evaluation and Research (CDER), in conjunction with the agency’s field organization, has developed and is piloting a new inspection protocol that will impact the scope of what investigators are looking for and how they are assessing and reporting what they find. The “New Inspection Protocol Project” (NIPP) expands the investigator’s focus
- [Analytical Methods Handoff Pivotal to Successful Manufacturing Site Transfer, and Multiple Pitfalls Lurk, BCG Consultant Stresses at Latin America CMC Strategy Forum](https://ipq.org/analytical-methods-handoff-pivotal-to-successful-manufacturing-site-transfer-and-multiple-pitfalls-lurk-bcg-consultant-stresses-at-latin-america-cmc-strategy-forum/) - The analytical methods handoff is pivotal to the overall success of a manufacturing process transfer from one location to another, and multiple pitfalls lurk, Biologics Consulting Group’s Christina Vessely cautioned at the 2015 Latin America CMC Strategy Forum organized by CASSS in Brasilia, Brazil in late August. Vessely stressed that facility location transfers shed hard
- [Stress Studies Are Playing Key Role For Roche/Genentech in Assessing Biomanufacturing Process Site Transfers](https://ipq.org/stress-studies-are-playing-key-role-for-rochegenentech-in-assessing-biomanufacturing-process-site-transfers/) - Stress studies are playing a key role for Roche/Genentech in the comparability assessments needed to support its transfer of biomanufacturing processes between sites, reflecting the time savings, sensitivity to differences, and high level of stability assurance that they provide. At the 2015 Latin America CMC Strategy Forum held in Brazil’s capitol city Brazilia in late
- [Broad-Based ICH Q12 Expert Working Group Supporting Initiative’s Urgency and Viability, EWG Members Affirm at GPhA Conference](https://ipq.org/broad-based-ich-q12-expert-working-group-supporting-initiatives-urgency-and-viability-ewg-members-affirm-at-gpha-conference/) - The broadening of the ICH Q12 Expert Working Group (EWG) to include parties not traditionally associated with the ICH process may be facilitating, rather than hindering, the effort to meet the tight timelines set up for the guideline’s completion as well as enhancing its global relevance, EWG members are affirming. The recognition across the different
- [FDA is Advising Biotech Product Applicants to More Clearly Justify Their Excipient Usage](https://ipq.org/fda-is-advising-biotech-product-applicants-to-more-clearly-justify-their-excipient-usage/) - FDA’s Office of Pharmaceutical Quality (OPQ) is asking biotech product sponsors to fully explain the process used to select excipients and to provide a risk assessment on potential interactions between the excipients and their proteins. The agency wants to be sure that the biotech manufacturers understand the full ramifications of the way they are using
- [Wholesalers and 3PLs Continue to Advocate for DSCSA Goals of Strong and Uniform Licensing and Pedigree Requirements Nationwide](https://ipq.org/wholesalers-and-3pls-continue-to-advocate-for-dscsa-goals-of-stringent-and-uniform-licensing-and-pedigree-requirements-nationwide/) - Wholesale distributors and third party logistics (3PLs) providers are continuing to affirm their desire to take on more stringent licensing and pedigree requirements in exchange for clarity and uniformity of the expectations across the U.S. This trade-off had been central to the broad support that the Drug Supply Chain Security Act (DSCSA) drew from these
- [ICH Q12 EWG Views Established Conditions as Pivotal in Evolving Lifecycle Regulation Internationally; EMA Workshop Provides Input](https://ipq.org/ich-q12-ewg-views-established-conditions-as-linchpin-in-evolving-lifecycle-regulation-internationally-ema-workshop-provides-input/) - The ICH Q12 Expert Working Group (EWG) is viewing “established conditions” as a linchpin concept in its effort to define and drive a more improvement friendly, simplified, and harmonized regulatory approach to product lifecycle management internationally. However, the EWG members also recognize the challenges on the table in defining the concept in a way that
- [Challenges of Implementing U.S. and Global Serialization Mandates Compel Industry Cooperation](https://ipq.org/challenges-of-dscsa-serialization-mandates-compel-industry-cooperative-efforts-gpha-expert-panel-stresses/) - Pharmaceutical companies are reaching a clear understanding that they will have to work closely together, and with their supply chain partners, to address the serialization and tracing requirements of the Drug Supply Chain Security Act (DSCSA) as they unfold in stages through 2023. The need for industry cooperation in understanding and dealing with the complex web
- [FDA’s Generics Office Overcomes Tough Challenges to Meet Year 3 GDUFA Goals, OGD’s Uhl Reports at GPhA Conference](https://ipq.org/fdas-generics-office-overcomes-tough-challenges-to-meet-year-3-gdufa-goals-ogds-uhl-reports-at-gpha-conference/) - A significant increase in controlled correspondences, easily correctable deficiencies, and information requests, along with a major reorganization, were among the tough challenges that the Office of Generic Drugs (OGD) overcame to meet the Year 3 goals of the Generic Drug User Fee Act (GDUFA) – the first year that goals came into play. Developing the
- [FDA’s API DMF Assessment Timelines Improve as eCTD Use Increases and OPQ’s New API Review Structure Takes Hold](https://ipq.org/fdas-api-dmf-assessment-timelines-improve-as-ectd-use-increases-and-opqs-new-api-review-structure-takes-hold/) - The increasing use of the electronic common technical document (eCTD) for submitting Type II Drug Master Files (DMFs) has contributed to a significant reduction in the amount of time it is taking FDA to do DMF completeness assessments (CA), and a significantly higher percentage of the electronic filings are clearing the CA review on the
- [Starting Materials Remains a Challenging Issue for Both Regulators and Industry; FDA DMF Assessments Show SM Information Gaps](https://ipq.org/starting-materials-remains-a-challenging-issue-for-both-regulators-and-industry-fda-dmf-assessments-show-sm-information-gaps/) - FDA reviewers are reporting that firms producing active pharmaceutical ingredients (APIs) are not always providing adequate information on their starting material (SM) decisions or on the fate and purge of process impurities in their Type II drug master file (DMF) applications. Reviewers must determine the adequacy of the SM designation as part of the DMF
- [Drug Product Quality Dashboard Taking Shape at FDA in Wake of OPQ Integration and Expanding Knowledge Base](https://ipq.org/drug-product-quality-dashboard-taking-shape-at-fda-in-wake-of-opq-integration-and-expanding-knowledge-base/) - The vision of having a product quality dashboard that would help guide FDA in regulating drug product lifecycles is emerging into more concrete form as the Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ) begins its second year. The dashboard is being designed to provide a comprehensive summary of the current state of
- [FDA’s OPQ Adapts ANDA Risk-Ranking Model for Drug Substance Reviews](https://ipq.org/fdas-opq-adapts-anda-risk-ranking-model-for-drug-substance-reviews/) - FDA’s Office of Pharmaceutical Quality (OPQ) has adapted the risk-ranking model developed for abbreviated new drug application (ANDA) reviews to its review of drug substances, with the goal of improving communications internally and with industry regarding API risks and deficiencies, and in turn, the overall efficiency and predictability of the process. The risk-ranking system allows
- [Emerging Technology Approvals Among FDA Office of Pharmaceutical Quality’s First-Year Achievements](https://ipq.org/emerging-technology-approvals-among-fda-office-of-pharmaceutical-qualitys-first-year-achievements/) - The positive impact that FDA’s Office of Pharmaceutical Quality (OPQ) has had during its first year in operation includes the extra support the agency has been able to provide for emerging technologies, as witnessed by the agency's first approvals of drug products using continuous manufacturing and 3D printing. Making the rounds at various conferences to report
- [Dissolution Testing and the BCS Among Quality Topics High on the OPQ/PQRI Agenda](https://ipq.org/dissolution-testing-and-the-bcs-among-quality-topics-high-on-the-opqpqri-agenda/) - Making dissolution testing and the Biopharmaceutics Classification System (BCS) it supports more meaningful is high on the agenda of the Office of Pharmaceutical Quality (OPQ) as it works with the Product Quality Research Institute (PQRI) to advance the quality regulatory process. Dissolution testing and the BCS were among the pressing issues receiving attention at a
- [FDA/Industry Track and Trace Pilot Planning Sheds Further Light on Complex Web of DSCSA Implementation Challenges](https://ipq.org/fdaindustry-track-and-trace-pilot-planning-sheds-further-light-on-complex-web-of-dscsa-implementation-challenges/) - The complexity of the web of issues that need to be worked through to arrive at a fully interoperable track and trace system in the U.S. for prescription pharmaceuticals by 2023 as mandated by the Drug Supply Chain Security Act (DSCSA) was in full display at an FDA pilot planning workshop in early April. The
- [Biopharmaceutical Industry Collaborating to Better Control Raw Material Quality Through Improved Supply Chain Communications](https://ipq.org/biopharmaceutical-industry-collaborating-to-better-control-raw-material-quality-through-improved-supply-chain-communications/) - The biopharmaceutical industry is working collaboratively to expand its ability to control the quality of the wide variety of raw materials that are being used in production and formulation through improved communications across the increasingly complex supply chains involved. Marking the heightened biotech industry awareness of the pressing need to better understand and address the
- [Excipient Regulatory Approaches Globally Differ Widely in Registration, GMP, DMF, and Application Submission Expectations](https://ipq.org/excipient-regulatory-approaches-globally-differ-widely-in-registration-gmp-dmf-and-application-submission-expectations/) - An analysis of the way excipients are handled by regulators around the world reveals significant differences in the registration/licensing and GMP requirements as well as both the form and content of what needs to be submitted to support drug applications. Regulatory agencies differ markedly in the specificity of their requirements for excipients, and whether and
- [Industry/Regulator Dialogue on Knowledge Management is Intensifying in Wake of ICH’s Q12 Initiative](https://ipq.org/industryregulator-dialogue-on-knowledge-management-is-intensifying-in-wake-of-ichs-q12-initiative/) - The focus has been intensifying at industry/regulator forums on how to evolve knowledge management programs, on the one hand, and the quality regulatory paradigm, on the other, to better support the goal of continuous improvement across the product lifecycle. How pharma companies are managing their knowledge internally and how that knowledge is flowing through and
- [FDA, MHRA and WHO Guidances Shed Further Light on Data Integrity Concerns](https://ipq.org/regulatorindustry-data-integrity-dialogue-moves-forward-with-fda-mhra-and-who-guidances/) - Guidances issued between April and July 2016 by FDA, UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), and the World Health Organization (WHO) are providing a stronger foundation for the industry/regulator dialogue around the world on where the current gaps are in industry's oversight of data integrity (DI) and how those gaps should be filled.
- [Industry Comments on FDA’s Draft Data Integrity Guidance Reveal Regulatory Challenges](https://ipq.org/rutherford/) - The number and depth of comments FDA received on its new draft data integrity (DI) guidance, and the dialogue the guidance has generated at recent public forums, indicate the high profile nature, dimension, and complexity of the challenges regulators face in overseeing and seeking to advance industry DI practices. The comments center around industry concern
- [Regulator Expectation for Handling Data Integrity Concerns Draws Spotlight](https://ipq.org/cosgrove/) - U.S. and European regulators are giving a clear message at public meetings and in their written guidance that up-front communication with the agencies about data integrity lapses that a company has uncovered is critical to maintaining trust and avoiding more serious enforcement repercussions later. Industry, on the other hand, is pointing to the wide spectrum
- [Protein Sequence Variants, Process Development and Spec Setting Are Generating Queries from EU Biopharmaceutical CMC Assessors](https://ipq.org/protein-sequence-variants-process-development-and-spec-setting-are-generating-queries-from-eu-biopharmaceutical-cmc-assessors/) - Protein sequence variants have been generating more questions among European CMC regulators in reviewing monoclonal and recombinant product dossiers – joining process development/validation and specification setting as areas where they are often not finding what they need to complete the review. An informal survey of 20 recent biotech product CMC reviews by Ireland Health Products
- [IPEC Leaders Tout Benefits of Documented Risk Assessments Called for in Recent Industry and Regulator Excipient GMP Standards](https://ipq.org/ipec-leaders-tout-benefits-of-documented-risk-assessments-called-for-in-excipact-and-nsfipecansi-363-gmp-standards/) - IPEC leaders are touting the multilayered benefits to excipient manufacturers and their pharma customers of establishing and documenting the more formal risk assessment processes called for in the recent industry and regulator excipient GMP standards. Among those experts who have been endorsing the value of a more full deployment of the risk assessment processes provided
- [Focus Intensifying in Europe on Improving Drug/Device Combination Product Regulatory Communication](https://ipq.org/focus-intensifying-in-europe-on-improving-drugdevice-combination-product-regulatory-communication/) - The challenges of the CMC regulatory process for drug/device combination products are getting increasing attention in Europe as industry and regulators join in the search for clearer and more efficient communication channels and regulatory procedures. At issue is the control and regulatory oversight of the interplay between the different components of a combination product, which
- [Combination Product Regulatory Improvements Remain High on Pharma’s 2017 Wish List](https://ipq.org/combination-product-regulatory-improvements-remain-high-on-pharmas-2017-wish-list/) - Clearer, more review/inspection coherent, more risk-based, and more harmonized regulatory expectations across the expanding universe of drug/device combination products will continue to be a high-priority focus for the pharmaceutical industry during 2017. The stresses pharma has been feeling from the disconnects in the drug and device regulations, structures and processes are becoming more acute as
- [International Regulatory Initiatives Guide Agencies Down Info-Sharing/Reliance/Recognition Pathway; ICMRA Targets Initiative Coordination](https://ipq.org/international-regulatory-initiatives-guide-agencies-down-info-sharing-reliancerecognition-pathway-icmra-targets-initiative-coordination/) - A mapping of the complex web of organizations and initiatives through which regulators around the world are now interacting is a first step in the mission of the International Coalition of Medicines Regulatory Authorities (ICMRA) to better coordinate resources in addressing global challenges. The mapping project was carried out for ICMRA by the EMA, which
- [FDA’s Broad-Based Effort to “Modernize” Combination Product Regulatory Process in Full Swing](https://ipq.org/fdas-broad-based-effort-to-modernize-combination-product-regulatory-process-in-full-swing/) - FDA’s broad-based effort to “modernize” its regulatory process for products that contain some combination of drugs, biologics and devices gained significant momentum during 2016, and the impact of the effort will continue to increase as 2017 progresses. Better assessing and addressing the challenges involved in coordinating the diverse regulatory requirements, processes, timelines, and philosophies that
- [Nanotechnology Under the Microscope at FDA](https://ipq.org/nanoparticles-small-particles-present-big-challenges/) - The rapidly expanding use of nanotechnology in therapeutic formulations is driving FDA to better define the regulatory and analytical framework needed to assess and address the potential concerns involved....
- [Global Excipient and Drug Manufacturers Weigh Implications of China’s New Excipient Dossier and “Bundling Review” Requirements](https://ipq.org/global-excipient-and-drug-manufacturers-weigh-implications-of-chinas-new-excipient-dossier-and-bundling-review-requirements/) - Global excipient and pharmaceutical manufacturers are weighing the complexities and consequences of the new “bundling review” requirement put in place by the China Food and Drug Administration (CFDA) in August 2016, which calls for excipient dossiers to be received, reviewed and approved as part of new drug applications. Prior to the new requirements, an excipient
- [European Pharmacopoeia Has Turned Up the Heat on ICH Q3D Implementation and Biotherapeutics](https://ipq.org/european-pharmacopoeia-has-turned-up-heat-on-ich-q3d-implementation-and-biotherapeutics/) - The July 2017 publishing by the European Pharmacopoeia (Ph. Eur.) of revisions to its general chapter, method, and monograph sections is the latest development in the effort by the pharmacopeia to align its coverage of elemental impurities (EI) with the implementation of the International Conference on Harmonization (ICH) Q3D guideline. The ICH Q3D implementation effort by
- [Quality System Transformation Needed for Next-Gen Product Acceleration, Johnson & Johnson’s Sallans Tells ISPE/FDA/PQRI Conference](https://ipq.org/tension-between-quality-regulatory-paradigm-and-innovationaccelerationharmonization-in-spotlight/) - A transformation in quality systems is needed to liberate the power of information, digital, manufacturing and analytical technologies and accelerate the next generation of medical products reaching the patient, Johnson & Johnson Chief Quality Officer Francois Sallans affirmed in his keynote address at the opening of the ISPE/FDA/PQRI Quality Manufacturing Conference in June. Quality systems
- [Industry/Regulator Communication is Linchpin in Addressing Cell/Gene Therapy CMC Challenges, Experts on Both Sides Are Affirming](https://ipq.org/industryregulator-communication-is-linchpin-in-addressing-cellgene-therapy-cmc-challenges-experts-on-both-sides-are-affirming/) - Industry and agency experts engaged with advanced therapies are stressing that the communication process between them is critical in clearing the CMC pathway for development of the products and that this communication needs to happen as early and as openly as possible to help sponsors navigate around the many pitfalls that lie along the journey.
- [Facility and Excipient Information Shortfalls Identified by FDA As Among Key Contributors to ANDA Review Delays; GDUFA II Driving Expanded Guidance](https://ipq.org/facility-and-excipient-information-shortfalls-identified-by-fda-as-among-key-contributors-to-anda-review-delays-gdufa-ii-driving-expanded-guidance-2/) - FDA’s Office of Generic Drugs (OGD) is cautioning ANDA sponsors to pay more attention to making sure that current information is provided on all of the facilities involved in the development, manufacturing, control testing and warehousing of APIs and finished dosage forms in both the Form 356h and application module 3.2.S.2. OGD has been highlighting
- [Opening Panel at CASSS 2018 WCBP Conference Assesses FDA’s 2017 CMC Regulatory Experience with Biotherapeutics and Key Challenges Going Forward](https://ipq.org/opening-panel-at-casss-2018-wcbp-conference-assesses-fdas-2017-cmc-regulatory-experience-with-biotherapeutics-and-key-challenges-going-forward-2/) - The opening plenary session of the 2018 CASSS Well-Characterized Biotechnology Products (WCBP) Conference, brought together a panel of FDA senior officials engaged in the CMC review process for biological products to assess the 2017 learnings and what the agency and industry needs to do to address the regulatory challenges and stresses going forward. The dialogue
- [Understanding Drug/Device Terminology Differences is Critical to Combination Product Control and Regulatory Communications, Industry Experts are Stressing](https://ipq.org/understanding-drugdevice-terminology-differences-is-critical-to-combination-product-control-and-regulatory-communications-industry-experts-are-stressing/) - Industry experts are stressing that the payoff for combination products in understanding and bridging the drug/biologic/device terminology differences is a smoother development process, a simpler, more effective control system, and better communications with CMC reviewers and GMP inspectors. The challenge is to tighten the linkages between risk management and the control strategy for combination products.
- [Pharma is Exploring How to Maximize ICH Q12 Value in Practice; Q12 EWG Encourages Feedback](https://ipq.org/pharma-is-exploring-how-to-maximize-ich-q12-value-in-practice-q12-ewg-encourages-feedback/) - Pharmaceutical manufacturers are exploring how the ICH Q12 lifecycle management concepts can be implemented internally and in their interactions with regulators to maximize the benefits in practice.
- [IPQ Monthly Update – March/April 2019 in Review](https://ipq.org/ipq-monthly-update-march-april-2019-in-review/) - The March/April 2019 issue provides the first two in a series of four IPQ stories on the current developments and industry/regulator interactions around data integrity. Explored are: ● the revisions that FDA and PIC/S have made to their DI guidances as part of a deepening pool of resources that industry now has available to support its data governance efforts, and ● how the role of quality culture is getting more attention as the regulator and industry DI guidances evolve.
- [IPQ Monthly Update – May 2019 in Review](https://ipq.org/ipq-monthly-update-may-2019-in-review/) - The May 2019 Monthly Update provides the last two in a series of four IPQ stories on the current developments and industry/regulator interactions around data integrity. Explored are: ● the regulatory/industry interactions, initiatives, and findings on the detection of DI lapses, preparing for inspections, and remediation, and ● the technical challenges of data management as the data pool grows, and the strategies MHRA and industry experts are recommending to meet them. [The March/April Monthly Update provides the first two stories in IPQ’s DI series.]
- [IPQ Monthly Update – June 2019 in Review](https://ipq.org/ipq-monthly-update-june-2019-in-review/) - The first story in IPQ’s June issue provides an update on the effort going on in Europe to create a more transparent, effective, and uniform process for regulating the quality of drug-device combination (DDC) products and how a draft guideline issued in June is contributing to that effort. The second explores the regulatory developments in China, the implications for pharma and excipient suppliers producing products for a global market, and how IPEC is urging China to more closely align with international norms.
- [IPQ Monthly Update – July 2019 in Review](https://ipq.org/ipq-monthly-update-july-2019-in-review/) - The first story in IPQ’s Monthly Update for July explores the FDA/CDER efforts to make its quality review process more standardized, transparent, streamlined, IT rich, and knowledge management friendly through its interrelated KASA and PQ/CMC initiatives. The second story explores the attention industry and regulators are now giving to the complex web of issues that come into play in the effective use of preservatives in pharmaceuticals.
- [IPQ Monthly Update – August 2019 in Review](https://ipq.org/ipq-monthly-update-august-2019-in-review/) - The three stories in the Monthly Update for August explore facets of the intense discussions that are now taking place at industry/regulator forums on the CMC challenges that need to be faced en route to realizing the promise of cell and gene therapies. In focus are: ● the dialogue at the NIIMBL annual meeting on these challenges and the industry/agency/academia collaboration needed to meet them, and ● an exploration by CBER and industry experts on the added CMC pressures created for CGTs by accelerated development and review timelines and how these pressures can be dealt with.
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- [Tier 1](https://ipq.org/product/number-of-employees-up-to-100/) - *Includes a 3% processing fee.
- [Tier 3](https://ipq.org/product/number-of-employees-500-1000/) - *Includes a 3% processing fee.
- [Tier 4](https://ipq.org/product/number-of-employees-1000-2000/) - *Includes a 3% processing fee.
- [Tier 5](https://ipq.org/product/number-of-employees-2000-5000/) - *Includes a 3% processing fee.
- [Tier 7](https://ipq.org/product/number-of-employees-10000-20000/) - *Includes a 3% processing fee.
- [Tier 6](https://ipq.org/product/number-of-employees-5000-10000/) - *Includes a 3% processing fee.
- [Tier 8](https://ipq.org/product/number-of-employees-above-100000/) - *Includes a 3% processing fee.

## Categories

- [Uncategorized](https://ipq.org/category/uncategorized/)
- [Monthly Updates](https://ipq.org/category/monthly-updates/)
- [News in Depth](https://ipq.org/category/news-in-depth/)
- [Staff](https://ipq.org/category/staff/)
- [Weekly](https://ipq.org/category/weekly/)

## Product categories

- [Uncategorized](https://ipq.org/product-category/uncategorized/)
- [Individual](https://ipq.org/product-category/individual/)
- [Company](https://ipq.org/product-category/company/)
- [Uni / Gov](https://ipq.org/product-category/uni-gov/)
- [Test](https://ipq.org/product-category/test/)