A3P – One year after Annex 1 implementation

The new Annex 1 published on 25 of August 2023The aim of this document is to reduce the risks of product contamination in the manufacturing process of a sterile product, especially when it is an aseptic process and not a terminal sterilization process. It includes updates of regulations, changes in other chapters of the GMP, use of tools described in the ICH Q9 and Q10 guidelines, aims to eliminate ambiguities and considers advances in new technologies.
Challenges, learning and lessons learned will be discussed at the conference one year after the entry into force of Annex 1.
The event will take place on November 14, 2024 at the Hotel SB Diagonal Zero, Barcelona.
Click here to go to the A3P website.