EMA Releases Draft Revision of GMP Chapter 4 for Public Comment

On 7 July 2025, the EMA published draft updates for Chapter 4, Annex 11, and Annex 22, open for comment until 7 October 2025. The revised Chapter 4 (Documentation) replaces the 2011 version and reflects advancements in digital technologies and GMP documentation practices.

Expanded from 9 to 17 pages, the draft emphasizes a life cycle approach, integrates ICH Q9 risk management, and addresses data governance, outsourcing, and AI use in batch release.

It includes detailed expectations for master documents, electronic and hybrid signatures, and retention periods, especially for clinical trial and ATMP samples. The document reinforces ALCOA++ principles for data integrity but introduces new terminology that may prompt discussion, such as the unclear definition of raw data.

While the update improves clarity, it may increase quality control costs. Comments can be submitted via the EMA’s “Consultations” page.

30-07-2025