Issue link: https://www.e-digitaleditions.com/i/1373953
Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING EBOOK 2021 35 Kelly Davis-Claeys, director, regulatory affairs at Catalent Bloomington, and Mo Heidaran, vice president, technical at Parexel Consulting, provide additional insight into the future impact of these pandemic challenges and short-term regulations in the following. FDA COVID-19 regulations PharmTech: Several guidelines have been published by FDA for manufacturing and development of vaccines and other treatments during the COVID- 19 pandemic. Do you see any of these 'emergency' guidelines becoming permanent after the pan- demic is over? Davis-Claeys (Catalent Bloomington): Emergency Use Authorization (EUA) allows FDA to authorize un- approved medical products or unapproved uses of approved medical products for use in an emer- gency to diagnose, treat, or prevent serious or life- threatening diseases or conditions when there are no adequate, approved, and available alternatives. In 2017, FDA issued Guidance for Industry, Emer- gency Use Authorization of Medical Products and Related Authorities, which describes the criteria for issuance, submission requirements, as well as con- ditions of authorization (4). Although COVID-19 is the most recent global pandemic, it is not the first EUA situation, and these guidances will re- main effective for future use. It is likely that FDA will also evaluate COVID- 19 specific guidances for transition to general guidances for use with non-COVID-19 products. As we have worked through this pandemic, it has provided industry and FDA the opportunity to re-evaluate operating mechanisms. The use of remote audits, evaluation, and mitigation of sup- ply chain constraints, as well as the use of a ro- bust risk-based approach to product development, manufacture, and change management will likely continue past the current pandemic situation. PharmTech: Does FDA's guidance on changes to container closure systems for COVID-19 vac- cines (2) have any insights for manufacturers of non-COVID-19 fill/finish sterile manufacturing operations? Heidaran (Parexel Consulting): The guidance de- lineates what reporting category needs to be fol- lowed by manufacturers of certain changes to the CCS [container closure system]. This guidance is more explicit as evidenced by inclusion of several tables. In general, the content of this guidance is also applicable to non-COVID products as it does not deviate or lower the bar for the report- ing categories but provides additional clarifica- tion for use of comparability protocols to lower the reporting category. This practice is commonly used by the industry for lowering the reporting category from PAS [prior approval supplement] to CBE30 [changes being effected in 30 days] if the comparability protocol is approved. This tool enables manufacturers to implement the change faster under CBE category. It also provides fur- ther clarification about changes and what report- ing categories they belong to. Davis- Claeys (Catalent Bloomington): In recent years, FDA and other regulatory agencies have been transitioning to a more risk-based approach to post-approval changes. FDA Guidance for In- dustry, COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers (2), includes risk-based elements and alignment with ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Manage- ment Core Guideline Guidance for Industry (5);