European Commission Launches Public Consultation on Updated GMP Guidelines for AI, Computerized Systems, and Documentation

On July 7, 2025, the European Commission’s Directorate-General for Health and Food Safety opened a public consultation on proposed revisions to EudraLex Volume 4 – Good Manufacturing Practice (GMP) Guidelines. The updates apply to:

• Chapter 4: Documentation
• Annex 11: Computerized Systems
• Annex 22: Artificial Intelligence (newly introduced)

These proposed changes aim to modernize GMP practices by strengthening data integrity, integrating AI governance, and improving oversight of computerized systems and documentation in pharmaceutical manufacturing.

Key highlights:

• The updated Chapter 4 emphasizes risk-based documentation practices, along with enhanced management of electronic records and signatures, while ensuring the legibility and integrity of documentation across all formats.
• The revised Annex 11 reinforces the application of Quality Risk Management (QRM) throughout the lifecycle of computerized systems, introducing stronger controls for audit trials, system security, and supplier oversight.
• The newly introduced Annex 22 establishes a clear regulatory framework for the use of Artificial Intelligence in GMP environments, addressing requirements related to model validation, training data quality, performance metrics, and continuous human oversight.

Feedback deadline: October 7, 2025

Why it matters:
These revisions are expected to:

• Enhance regulatory clarity
• Align with emerging digital technologies
• Promote operational efficiency
• Introduce minimal new compliance burdens

Stakeholder input will play a critical role in shaping guidance that is practical and aligned with technological advances. These updates are especially relevant for professionals in Quality, Regulatory Affairs, IT compliance, and AI deployment in GMP-regulated environments.

Next steps
Stakeholders should review the draft revisions to Chapter 4, Annex 11, and Annex 22, assess internal impact, and coordinate cross-functional feedback. Comments must be submitted via the European Commission portal by October 7, 2025.

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FAQs

1. What is Annex 22 of the updated EU GMP guidelines?
   Annex 22 is a newly proposed section under EudraLex Volume 4. It sets out regulatory requirements for using Artificial Intelligence in pharmaceutical manufacturing, including model validation, training data standards, and human oversight.
2. What changes are being made to computerized systems under Annex 11?
   The updated Annex 11 introduces stricter Quality Risk Management practices for computerized systems. It focuses on audit trials, electronic signatures, system security, and supplier oversight.
3. What are the documentation requirements in the revised Chapter 4 of EU GMP?
   The revised Chapter 4 emphasizes data integrity, risk-based governance, and proper handling of documentation in all formats. It also strengthens requirements for managing electronic records and signatures.