Technical interpretation of PIC/S GMP guide Annex 1

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Technical interpretation of PIC/S GMP guide Annex 1 - Manufacture of sterile medicinal products

PIC/S has published a recommendation for the technical interpretation of Annex 1 on the Manufacture of Sterile Medicinal Products.


This recommendation summarizes the interpretations an inspector adopts during an inspection of the manufacture of sterile medicinal products. It reflects the most important changes introduced in the revised Annex 1, but is not intended to address all changes in the revision.


This recommendation came into effect on 1 January 2010.


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Contents


Document history

Purpose and scope

Basics

Definitions and abbreviations

New texts and their interpretation

Revision history


Technical interpretation of PIC/S GMP guide Annex 1


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