The GMP-Verlag offers a comparison document for download for this final version.
The draft of Annex 1 "Sterile and aseptic production" of the EU GMP guide kept many of those responsible in the pharmaceutical industry busy. On August 25, 2022, the long-awaited final version was released.
Also ask yourself the following questions:
This download will help you answer these questions.
The EU GMP Guideline Annex 1 "Manufacture of sterile medicinal products" in a comparison of the final version from 2022 with the draft version from February 2020.
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