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.
The 2022 ISPE Aseptic Conference features the breakout session "Aseptic Group Discussions: Annex 1 Implementation: Challenges and Opportunities" that will explore both the challenges and opportunities faced with implementation, including inspection approaches/experiences as well as the application of QRM principles. Watch this video to hear from session leader and program committee member Michael Higgins, Senior Compliance Advisor, Genentech.