Aseptic Group Discussions: Annex 1 Implementation: Challenges and Opportunities

Aseptic Group Discussions: Annex 1 Implementation: Challenges and Opportunities| The first publication of Annex 1 can be traced back to 1971 where it then described the foundational elements to ensure sterility of commercialized medicinal products.    Since that time Annex 1 has undergone a number of targeted updates but only recently has undergone a full review.  After two rounds of targeted consultation, with the most recent being completed July 2020, industry now waits for the final publication which is anticipated mid 2022.    The Annex 1 revision has far-reaching implications for many years to come.  This breakout session will afford the opportunity to share both the challenges and opportunities faced with implementation.  Potential areas of discussion related to Inspection approaches/experiences as well as the application of QRM principles will be explored.