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.
Thank you to all those who attended the 2023 ISPE Annual Meeting & Expo, and a big thank you to the sponsors for making this conference possible, and the program committee for curating an in-depth and interactive...
Congratulations to the 2023 ISPE Facility of the Year Award Winners
ISPE unveiled the prestigious 2023 Facility of the Year Award (FOYA) Overall Winner recipient during the FOYA Celebratory Reception and Banquet at the 2023 ISPE Annual Meeting & Expo. The event showcased the overall...
2023 Category Winners for Social Impact: Takeda
Takeda is a global values-based, R&D-driven biopharmaceutical leader committed to creating better health for people and a brighter future for the world. For more than 240 years, Takeda has focused on delivering...