ECA Task Force comments on Annex 22 Draft

On 7 July 2025, EU Commission published the new EU GMP Guide "Annex 22: Artificial Intelligence". Together with this new Annex it also issued the long awaited drafts for Annex 11 “Computerised Systems” as well as the the revised version of EU GMP Guide Chapter 4 “Documentation”. Comments on the three drafts were due until 7 October 2025.

The ECA Foundation formed an Annex 22 Task Force to prepare and submit comments on this new Annex - consisting of the following members:

Chair:
Wolfgang Schumacher, ECA IT & DI Compliance Group

Task Force Members:

Torsten Kneuss, Bayer
Haluk Dönmez, B. Braun
Philip Lienbacher, Takeda
Peter Schober, Gempex
Felix Krumbein, ECA Visual Inspection Group
Yves Samson, ECA IT & DI Compliance Group
Peter Schober, Gempex
Azade Pütz, Consultant
Monika Hupfauf, Lawyer
Dominik Hubertus, DHC Group

Please see the new ECA Annex 22 Task Force's letter to the EU Commission and their comments on the new Annex 22 Draft.

For more information you also may want to read the ECA news Drafts of EU GMP Guideline Annex 11, Annex 22 and Chapter 4 released for comment.