Tag Archives: EU GMP Annex 1

Anna Cluet

Contamination Control: Practical Steps to Compliance with EU GMP Annex 1

By Anna Cluet
Anna Cluet

Revised EU GMP Annex 1 requirements must be fulfilled by August 2023. Designed to protect and increase confidence in the sterility of these products, the new specifications are significant and wide-ranging, spanning the Quality system and the manufacturing process itself. Anna Cluet of Rephine discusses the practical specifics of designing and delivering a fit-for-purpose contamination control strategy.

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