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.
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.
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.
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.
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.
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.
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).
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).
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.
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.