EU GMP Annex 1 is undergoing a substantial revision. The Annex sets out the minimum standards for the manufacture of sterile products (both aseptically filled and terminally sterilized). A major focus within the Annex is on the need for a contamination control strategy and with applying the principles of quality risk management (QRM).
This webinar examines the main changes contained within the revision and what this signals for bio-pharmaceutical manufacturers. This includes the role of barrier technology to protect products, to novel technologies for assessing the manufacturing process.
Dr.Tim Sandle works for a sterile products manufacturer in the UK. He is also a visiting lecturer at the University of Manchester (teaching pharmaceutical microbiology) and University College London (training Qualified Persons). Dr. Sandle has written or edited 30 books and 165 peer reviewed papers, plus 500 technical papers relating to microbiology and pharmaceuticals.