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    A guide to EU GMP Annex 1

    Discover the main updates regarding the manufacture of sterile medicinal products detailed in the EU GMP Annex 1.

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    [Guides] Annex 1

    What’s inside?

    In this comprehensive guide to EU GMP Annex 1 you will learn:

    • An in-depth analysis of EU GMP Annex 1 requirements.
    • The application of the concepts outlined in Annex 1 to non-sterile product areas.
      Introduction of Quality Risk Manager (QRM) and Pharmaceutical Quality System (PQS) principles.
    • The implementation of the Contamination Control Strategy (CCS) and a continuous monitoring approach.

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