January 2017

Summary of Anticipated Changes to Annex 1

EU GMP Annex 1 on sterile product manufacturing is undergoing a major revision, which is being conducted jointly with PIC/S. This is a total re-write of this critical Annex. Whilst we have not had a formal draft published yet, we do now have a very good idea of the changes that will be in the draft when it is published, and of the areas of contention that are still being debated. This fish-bone diagram will provide you with the latest news regarding the revision of Annex 1, which will help sterile product producers prepare for the major changes that are coming.