26/27 January 2022
The EU GMP Guide Annex 15 was originally published in 2001. At the end of October 2012, the EU has announced to revise it. The particular goal was to integrate modern elements coming from ICH Q8, 9 and 10, to implement PAT and continuous manufacture concepts as well as to integrate changes in the chapters and Annexes of the GMP Guide. The revision was also supposed to cover changes of EMA´s Process Validation Guideline.
Now the draft for the revision of Annex 15 is published. All in all there is an abundance of new requirements. Some new terms are a bit "nebulous" and the whole document seems to be a little "spongy". Therefore, the ECA has set up this survey to get a feedback from the pharmaceutical industry. The summary of the feedback will be forwarded to the EU Commission and will also be published as news.
We would appreciate it if supported us in commenting the draft. Thank you in advance.