The European Commission has launched a targeted consultation on three important GMP documents:
- Revised Chapter 4 – Documentation
- Revised Annex 11 – Computerised Systems
- New Annex 22 – Artificial Intelligence
Why are these revisions being introduced?
These updates aim to reflect the increasing use of digital technologies and AI in pharmaceutical manufacturing while ensuring data integrity, quality, and regulatory alignment for manufacturers and national competent authorities.
How can stakeholders contribute to the new GMP Guidelines?
According to the European Commission, these three documents, taken together, aim to provide a comprehensive and robust framework that supports the implementation of IT technologies in pharmaceutical manufacturing while safeguarding product quality and patient safety.
Stakeholders are invited to submit their comments via the EU Survey tool.
- Deadline: 7 October 2025
More info and links to draft guidelines: