In order to assure a harmonised conduct of inspections, with respect to the 2022 revision of GMP Annex 1, this document provides answers to key questions related to the changes in Annex 1 raised during the revision process and after implementation of the new version.
This document reflects the most important changes, nevertheless it is not meant to address all changes within the Revision.
Purpose of this document is not to introduce any new GMP requirements