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Can sterile drug manufacturers implement EU GMP Annex 1 requirements before August? | Hogan Lovells

Published: January 17, 2023

In August 2022, the European Commission published a revision to Annex 1 “Manufacture of Sterile Medicinal Products” in EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines...

Source: jdsupra.com

Related Topics:

Commission DirectiveEuropean UnionEuropean CommissionCommission Delegated RegulationSterile Medicinal ProductsQuality SystemsQuality Risk ManagementContainment Control StrategyRestricted Access Barrier SystemsAseptic Process SimulationsDrug Products ProducedAseptic ProcessingCurrent Good Manufacturing