Whitepaper: EU GMP Annex – sterile manufacturing
Posted: 22 March 2021 | Reading Scientific Services Limited | No comments yet
This whitepaper considers the latest EU GMP Annex 1 draft and its impact on the control and release of sterile products.
RSSL’s whitepaper “EU GMP Annex 1 – Implications for Sterile Products Manufacture”, discusses the latest regulatory updates and how they differ to current guidance. This whitepaper provides advice on preparing for the regulations before they become final. In addition, the elements required for a good contamination control strategy and the importance of quality risk management in relation to sterile products will also be discussed.
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Analytical techniques, Biologics, Biopharmaceuticals, Bioprocessing, Chromatography, Endotoxin, Environmental Monitoring, Excipients, Gene therapy, Good Manufacturing Practice (GMP), Manufacturing, Medical Devices, Microbiology, Microscopy, Outsourcing, Proteomics, QA/QC, Regulation & Legislation, Research & Development (R&D), Stem Cells, Supply Chain, Vaccines