Warning Letters and European Non-Compliance Reports - IPQ.org
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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.

ICH’s 2003 Vision of a Harmonized Quality Regulatory Approach that Fosters Innovation Continued to...

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

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

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

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

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

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

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

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.

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.