ISPE was one of the organizations chosen by EMA to comment on the draft of Annex 1 that was published in February 2020, and comments were submitted in July 2020.
In this webinar, we will summarize the commenting process and the key issues highlighted during the Annex 1: Manufacture of Sterile Products session from the 2020 ISPE Annual Meeting and Expo.
During the session, a panel of regulators from EMA, Health Canada, MHRA, FDA and TGA, discussed in detail several technical topics which will be shared in this webinar.
Topics covered include cleanroom qualification and cleanroom monitoring, the use of barrier systems like RABS and isolators, Aseptic Process Simulations (APS), sterile filtration and PUPSIT.
The regulators also described their way forward in terms of reviewing the industry comments and the timeline for next steps.
The webinar will include an interactive Q&A-session, where we will try to answer any questions from the audience.