Abstract
About this talk
The new EU GMP Annex 1 for sterile Manufacturing was published in August 2022. The industry does now have one year's time for implementation. Exception loading and unloading for the Lyophilization which provides an implementation time of two years. What does this mean for sterile Manufacturing but also for the Manufacturing of Cell and Gene Products. For Cell and Gene (ATMPs) the PIC/s published in 2021 Annex 2A for ATMPs and it might be that PIC/s link their Annex 1 with Annex 2 A which would mean higher requirements also for the manufacturing of ATMPs. The presentation will be focused on Contamination Control Strategy, Barrier Systems as those on of the major new areas to consider.
Audience Take Away Notes:
- Comparison between EU GMP Annex 1 and PIC/s Annex 2A
- What to consider when implementation a CCS
- What is the right Barrier Solution for my process
Speaker
About the speaker
