INTERNATIONAL PHARMACEUTICAL QUALITY
Inside the Global Regulatory Dialogue

The News In Depth

  • NASEM-Led Study for FDA is Helping Drive Industry/Regulator Agenda on Innovation Needs

    August 29, 2022

    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

    NASEM-Led Study for FDA is Helping Drive Industry/Regulator Agenda on Innovation Needs
  • Pandemic Experience Showcases the Potential for Faster Innovation, More Collaboration, and Workplace and Operations Modernization

    June 23, 2022

    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

    Pandemic Experience Showcases the Potential for Faster Innovation, More Collaboration, and Workplace and Operations Modernization
  • Progress in Addressing Impurity Challenges in Focus at USP’s 2022 Peptide/Oligo Workshop

    May 10, 2022

    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

    Progress in Addressing Impurity Challenges in Focus at USP’s 2022 Peptide/Oligo Workshop
  • Pandemic Experience and Supply-Chain Risk Management Expectations Increase Attention on Excipient GMP Third-Party Auditing

    May 1, 2022

    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.

    Pandemic Experience and Supply-Chain Risk Management Expectations Increase Attention on Excipient GMP Third-Party Auditing
  • Janet Woodcock and Jeff Baker will Continue to Play Key Manufacturing Innovation Roles in New FDA and NIIMBL Positions

    February 28, 2022

    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.

    Janet Woodcock and Jeff Baker will Continue to Play Key Manufacturing Innovation Roles in New FDA and NIIMBL Positions
  • FDA’s KASA and Related PQ/CMC Initiatives on Improving CMC Data Structuring and Sharing Will Help Support ICH M4Q Revision

    February 17, 2022

    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

    FDA’s KASA and Related PQ/CMC Initiatives on Improving CMC Data Structuring and Sharing Will Help Support ICH M4Q Revision
  • Key GMP Focal Points in Europe Include Guidance Revisions, New Vet Regulations, and Adaptive Assessment/Inspection Approaches

    January 12, 2022

    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

    Key GMP Focal Points in Europe Include Guidance Revisions, New Vet Regulations, and Adaptive Assessment/Inspection Approaches
  • USP and Ph. Eur. Initiatives in the Biologics Arena Continue to Bear Fruit; FDA Joins the Pharmacopeias in Upgrading Particulate Guidance

    December 28, 2021

    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

    USP and Ph. Eur. Initiatives in the Biologics Arena Continue to Bear Fruit; FDA Joins the Pharmacopeias in Upgrading Particulate Guidance
  • COVID Vaccine Industry Project Leaders Are Sharing Insights on How the Daunting CMC Challenges Were Addressed

    November 18, 2021

    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

    COVID Vaccine Industry Project Leaders Are Sharing Insights on How the Daunting CMC Challenges Were Addressed
  • Biomanufacturer Raw Material Control on Regulatory Front Burner as Analytical Power and Formulation Challenges Intensify

    September 9, 2021

    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

    Biomanufacturer Raw Material Control on Regulatory Front Burner as Analytical Power and Formulation Challenges Intensify
  • Manufacturing, Impurities, and Characterization Methods Are Key Regulatory Focal Points for Peptides and Oligonucleotides

    August 9, 2021

    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

    Manufacturing, Impurities, and Characterization Methods Are Key Regulatory Focal Points for Peptides and Oligonucleotides
  • A Confluence of Forces Is Now Spurring Combination Product Regulatory Reform in Europe

    July 2, 2021

    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

    A Confluence of Forces Is Now Spurring Combination Product Regulatory Reform in Europe
  • Pandemic Urgencies Highlight Constraints in Manufacturing Change Regulatory Paradigm and Where Adjustments Are Needed

    May 11, 2021

    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

    Pandemic Urgencies Highlight Constraints in Manufacturing Change Regulatory Paradigm and Where Adjustments Are Needed
  • Regulators Are Exploring with Industry How to Strengthen Quality Risk Management Practices, with Revision of ICH Q9 a Key Focal Point

    April 29, 2021

    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

    Regulators Are Exploring with Industry How to Strengthen Quality Risk Management Practices, with Revision of ICH Q9 a Key Focal Point
  • Regulators Share Pandemic’s CMC Impact at CASSS Japan Forum; Guidance Output Continues Apace in Q1 2021

    April 1, 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 Share Pandemic’s CMC Impact at CASSS Japan Forum; Guidance Output Continues Apace in Q1 2021
  • Academia/Industry Collaboration Intensifies on Addressing the Pressing Needs in Biopharma Workforce Development

    March 18, 2021

    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

    Academia/Industry Collaboration Intensifies on Addressing the Pressing Needs in Biopharma Workforce Development
  • Latest Improvements in FDA’s Inactive Ingredient Database Include Change Log and Use of Maximum Daily Exposure

    February 9, 2021

    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.”

    Latest Improvements in FDA’s Inactive Ingredient Database Include Change Log and Use of Maximum Daily Exposure
  • Recent Technology and Partnership Advances Made Possible Precision and Speed of Vaccine Response to Pandemic, NIAID’s Graham Stresses at CASSS WCBP Conference

    February 2, 2021

    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.

    Recent Technology and Partnership Advances Made Possible Precision and Speed of Vaccine Response to Pandemic, NIAID’s Graham Stresses at CASSS WCBP Conference
  • Pandemic Intensifies USP’s Focus on Supply Chain Vulnerabilities and Vaccine Development

    January 28, 2021

    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.

    Pandemic Intensifies USP’s Focus on Supply Chain Vulnerabilities and Vaccine Development
  • Pandemic Spurs Deepening of Pharmacopoeia/Regulator/Industry Communication Channels

    December 23, 2020

    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

    Pandemic Spurs Deepening of Pharmacopoeia/Regulator/Industry Communication Channels
  • COVID Vaccine Global Distribution Challenges Explored by Bio Supply Management Alliance (BSMA) Panel of European Experts

    December 3, 2020

    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.

    COVID Vaccine Global Distribution Challenges Explored by Bio Supply Management Alliance (BSMA) Panel of European Experts
  • Pandemic Stresses Increase FDA Attention on Risk Management Plans for Drug Shortage Prevention and Mitigation

    November 15, 2020

    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.

    Pandemic Stresses Increase FDA Attention on Risk Management Plans for Drug Shortage Prevention and Mitigation
  • USP’s Global Efforts to Strengthen Standards and Accelerate Innovation for Biologics Include ICH Engagement

    November 9, 2020

    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.

    USP’s Global Efforts to Strengthen Standards and Accelerate Innovation for Biologics Include ICH Engagement
  • CBER Director Marks Traverses the Complex COVID-19 Vaccine/Therapy Regulatory Landscape at FDLI’s Annual Conference

    October 13, 2020

    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.

    CBER Director Marks Traverses the Complex COVID-19 Vaccine/Therapy Regulatory Landscape at FDLI’s Annual Conference
  • Stronger Unapproved Stem-Cell Enforcement Accompanies FDA Center for Biologics’ Cell and Gene Therapy Advancement Efforts

    September 14, 2020

    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.

    Stronger Unapproved Stem-Cell Enforcement Accompanies FDA Center for Biologics’ Cell and Gene Therapy Advancement Efforts

Hotspots in the Dialogue

IPQ’s meeting schedule through December includes:

SEPTEMBER

OCTOBER

NOVEMBER

DECEMBER

Korea Global Bio Conference
(Sept 5-7) Seoul, Korea

PDA Manufacturing Quality Conference
(Sept 6-8) Singapore

IGBA Annual Conference
(Sept 7-9) Kuala Lumpur, Malaysia

MedTech & Pharma Platform Annual Conference
(Sept 8) Basel, Switzerland

TUDublin/PDA Ireland QRM Workshop
(Sept 8) Dublin, Ireland

RAPS Convergence
(Sept 11-13) Phoenix, Arizona

DIA/FDA/PMDA/TGA/CDSCO Advanced Manufacturing Workshop
(Sep 12-13) Virtual Only

PDA/FDA Joint Regulatory Conference
(Sept 12-14) Washington, DC

IABS Global Harmonized Specs Workshop
(POSTPONED) Basel, Switzerland

PDA Data Integrity Workshop
(Sept 15-16) Washington, DC

CASSS CMC Strategy Forum China
(Sep 15-16) China

CASSS CE Analysis Symposium
(Sept 18-21) Portland, OR

EDQM: Ph. Eur. 11th Edition Conference
(Sept 19-21) Strasbourg, France

DIA Biosimilars Meeting
(Sept 20-21) Arlington VA

CHPA Regulatory & Quality Conference
(Sept 20-21) Bethesda, MD

PDA Biomanufacturing Conference
(Sept 20-21) Amsterdam, The Netherlands

PDA Annex 1 Workshop
(Sept 22-23) Amsterdam, The Netherlands

ISPE China Conference
(Sep 22-24) China

ASCGT Policy Summit
(Sept 26-27) Washington, DC

IABS Conference on Next Gen Sequencing
(Sept 27-28) Rockville, MD

DIA Accelerating CMC Workshop
(Sept 27-28) Seville, Spain

CASSS Mass Spec Symposium
(Sept 27-30) Long Beach, CA

PDA Quality & Regulations Conference
(Oct 5-6) Amsterdam, The Netherlands

Medicines for Europe Biosimilars Medicines Conference
(Oct 6-7) Brussels, Belgium

DIA Japan Annual Meeting
(Oct 9-11) Tokyo, Japan and Virtual

PDA Pharmaceutical Microbiology Conference
(Oct 10-12) Washington, D.C.

FDA NanoDay Symposium
(Oct 11)

ARMI BioFabUSA Meeting on the Mesa
(Oct 11-13) Carlsbad, CA

Canna Pharma 2022
(Oct 12-13) San Diego, CA

PDA Rapid Microbiological Methods Workshop
(Oct 12-13) Washington, D.C.

AAPS 2022 PHARMSCI 360
(Oct 16-19) Boston, MA

CASSS CMC Strategy Forum Europe
(Oct 17-19) Brugge, Belgium

TOPRA Human Medicines Symposium
(Oct 17-19) Vienna, Austria

DIA Canadian Annual Meeting
(Oct 18-19) Ottawa, Canada

PDA Prefilled Syringes and Injection Devices Conference
(Oct 18-19) Palm Springs, CA

TOPRA Regulatory Updates for Start-ups SMEs and Academia
(Oct 19) Vienna, Austria

PDA Annex 1 Workshop
(Oct 20-21) Palm Springs, CA

PDA Aseptic Processing of Biopharmaceuticals Conference
(Oct 25-27) Incheon, South Korea

ARMI BioFabUSA Meeting in the Millyard
(Oct 25-27) Manchester, NH

DIA Complex Generics Conference
(Oct 27-28) Tysons Corners, VA

ISPE Annual Meeting & Expo
(Oct 30-Nov 2) Orlando, FL and Virtual

AAM GRx+Biosims Conference
(Nov 7-9) Bethesda, MD

AFDO/RAPS Combination Products Summit
(Nov 7-9) Columbus, OH

PDA Visual Inspection Workshop
(Nov 8) Berlin, Germany

AAM GBW Annual Biosimilsars Week Podcast
(Nov 14-19) Virtual Only

2022 PDA Asia Pacific Regulatory Conference
(Nov 14-16) Virtual Only

FDA/PQRI Point-of-Care Manufacturing Workshop
(Nov 14-16) Virtual Only

World Vaccine & Immunotherapy Congress
(Nov 28-Dec 1) San Diego, CA

DIA-EUCOPE ATMP Workshop
(Nov 29-30) Basel, Switzerland

CASSS CMC Strategy Forum Japan
(Dec 5-6) Tokyo, Japan

ISPE Pharma 4.0 and Annex 1 Conference
(Dec 7-8) Vienna, Austria

FDLI Compliance Conference
(Dec 7-8) Washington, DC

IPQ would like to thank our partners: