EU GMP Annex I Is A Top Priority For EMA While Industry Has Lingering Concerns

 
• By Joanne S. Eglovitch

Questions about contamination control strategy raised as European Medicines Agency makes EU GMP Annex I revision a top priority in its 2021 work plan.

Bosch: Capping machine with highly an isolator is a hermetically sealed system with a complete separation of operator and process area © Bosch Packaging Technology
Sterile Drug Manufacturers May Have New Annex 1 Sooner Rather Than Later • Source: Shutterstock

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