Annex 1, the European Union’s revised GMP requirements for the manufacturing of sterile medicinal products will take effect on 25 August 2023. As the document will also be adopted by PIC/S and WHO, the requirements become global. Companies will have to start preparing for implementation immediately. Key questions are: How to properly incorporate the principles of Contamination Control Strategy (CCS) and Quality Risk management (QRM) in sterile drug manufacturing? Do aseptic fill-finish operations in RABS and isolators need to be redesigned, based on the new requirements? And how can the new, more precise requirements in Aseptic Process Simulations (APS) aka Media Fills be implemented? The participants in this panel discussion have been intimately involved in industry’s commenting of the draft versions of Annex 1 and can therefore give background information and behind the scenes insights on how this document was developed.
Director Aseptic Processing SME,
Sanofi Pasteur – Swiftwater
Sr. Fellow - Aseptic and Sterile Products, Vertical Market Leader,