A Harmonized Understanding Of Annex 1 And USP 1207 – Deploying Package Inspection Methods To Achieve Quality And Compliance" Webinar Announced
USP 1207 was formally published in 2017 to encourage the use of deterministic test methods for testing container closure integrity. In August of 2023, Annex 1 – Manufacture of Sterile Medical Products went live as a regulatory requirement. While Annex 1 broadly addresses the sterile manufacturing arena, it does have specific implications for packaging. USP 1207 is more specific in guidance and focuses on prescribing appropriate methods to test package integrity. The two regulatory guidelines do not conflict, but where one guidance may offer broader guidance, the other may suggest a specific remedy. The discussion will address specifics in both USP 1207 and Annex 1 and offer balanced interpretation where the documents offer certain interpretive freedoms. Technologies listed in USP 1207 will be highlighted. Strategies will be presented for meeting sterile manufacturing requirements related to sampling, batch sizes, and aligning with traditional microbial guidelines set out by Annex 1. The discussion will draw on the experience and feedback of regulators and drug manufacturers with a panel Q&A discussion.