White Paper: Top 10 Revisions in The EC Annex 1 (2020): A Harmonization of Global Sterile Filling
Published December 2021
Abstract:
The manufacturing guidance of sterile medicinal products has been revised by the EMA inspector working group. The revisions consist of organizing and structuring requirements into ten distinct sections along with providing additional details on current requirements. This white paper explores the reasons for the revisions, key revisions made section by section, challenges, timelines, and the next steps to consider maintaining compliance.
Keywords: sterile medicinal products, non-sterile products, EU GMP Annex 1, sterile manufacturing, drug development, lyophilization, contamination control strategy, quality risk management, ICH, pharmaceutical quality system
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