Whitepapers/App Notes/Posters

Whitepaper: EU GMP Annex – sterile manufacturing

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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