ICH Q12 Implementation Strategies Discussed During Webinar on Challenges and Success of ICH Q12

ICH Q12 (Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management) is a transformative document shaping global regulatory submissions in the post-approval state and is currently being implemented across regions. Bringing together industry leads and FDA for the discussion, the webinar focused on tactical issues faced by FDA and industry as ICH Q12 paves the way for harmonization of management of post-approval changes.

Nina Cauchon, Director Regulatory Affairs, CMC at Amgen Inc. and one of the moderators of the ISPE ICH Q12 working group, opened the webinar. The speakers and panelists included Connie Langer, Director, CMC-Global Regulatory at Pfizer Inc.; Saroj Ramdas, GSK Fellow & Director CMC Regulatory Advocacy, Strategy & Policy at GlaxoSmithKline; Joel Welch, Associate Director for Biosimilar & Regulatory Policy (Acting) at FDA/CDER; Kim Wolfram, Director, Global Regulatory CMC Biologics & Gene Therapy at Biogen; and Eli Zavialov, PhD, Scientific Director at Johnson & Johnson and the ISPE ICH Q12 working group lead.

Joel Welch led the discussion on progress FDA is making in implementing ICH Q12 concepts. Significant training has been developed and initiated in a four-phase approach to build awareness and capability of FDA staff to help with successful implementation of ICH Q12. An FDA pilot program was implemented as part of Phase 3, giving FDA and industry experience in assessing proposed established conditions (ECs) to existing products. There were eight supplements, and one original application. Phase 4 is to be implemented, where assessment teams will help guide consistency across submissions. Joel spoke to key takeaways from FDA’s experience with the Pilot, highlighting the diverse approaches taken and nomenclature used by industry in implementing ICH Q12. The challenge remains to identify how to capture succinctly in applications process knowledge and translate this knowledge to a risk-based assessment of proposed ECs.

Eli Zavialov led the follow-on discussion regarding first steps toward ICH Q12 implementation at J&J. J&J’s internal ICH Q12 cross-functional team was formed in 2018 with the goal of developing practical implementation approaches to ICH Q12 through industry and regulator engagement. Eli spoke to the key challenge of striking the appropriate balance in supplying sufficient dossier details with maintaining lifecycle flexibility. Although not included in the final Q12 document, J&J found that the use of the term “key process parameter” was useful in interpreting the risk continuum for process parameters as intermediate between critical and non-critical.

Kim Wolfram highlighted the challenges of post-approval change management as it introduces supply chain complexity and risk due to regulatory complexity and long approval timelines. Opportunities exist with successful ICH Q12 implementation to introduce a science- and risk-based framework to facilitate management of post approval changes and keep quality at the forefront of top priorities for manufacturers. Challenges will continue for non-ICH countries; however global alignment of core elements of the dossier should help reduce complexity and increase access to therapies for all patients.

Lastly, Saroj Ramdas spoke to GSK’s key experiences from the FDA Established Conditions Pilot Program. Technical risk assessment severity scores were leveraged as part of a risk management exercise to help identify ECs using product knowledge. As a key outcome of the pilot, Saroj spoke to the benefits of participating in the pilot, which led to a reduction from 21 to seven in the number of parameters that would require regulatory action with others being managed using the pharmaceutical quality system, thus providing greater flexibility to implement changes while maintaining product quality.

The webinar concluded with a panel discussion with the industry and FDA speakers moderated by Connie Langer. Joel Welch commented on the need for shared vocabulary and readiness to ensure harmonization with other health authority agencies. With the implementation working group, FDA is laying the foundation to support a global approach to ICH Q12. Welch also shared some details on what the Agency found challenging as part of the Established Conditions Pilot, highlighting different approaches taken by industry related to tiering of criticality of ECs.

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