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

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

The pharmaceutical industry still has concerns about revisions to the European Commission’s EU GMP Annex 1 for sterile drug products, which the European Medicines Agency says is a high priority item in its 2021 workplan.

Industry and regulatory experts explained some recent developments taking place with Annex 1 and addressed some areas that are still generating confusion and discussed some other “high impact” areas that will be affected by the annex at the International Society for Pharmaceutical

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