What’s Changing—and Why It Matters
These revisions are more than just technical updates—they represent a strategic alignment of GMP requirements with today’s technological capabilities. They focus on key priorities such as data integrity, hybrid and digital systems, and the regulatory oversight of AI-based decision-making.
New Annex 22 – Artificial Intelligence
Annex 22 is a groundbreaking addition. It sets out regulatory expectations for the use of AI and machine learning (ML) models that have a direct GMP impact—such as those used in product release decisions or data classification.
However, there are limits. This annex does not apply to generative AI models (like ChatGPT) or adaptive, self-learning systems that don’t exhibit fixed behavior.
Key areas of focus in Annex 22 include:
The goal? Ensure AI is treated as a critical process, with appropriate controls, documentation, and accountability.
Revised Chapter 4 – Documentation
The proposed changes to Chapter 4 reinforce the foundational role of documentation in maintaining GMP compliance — especially in a digital world. The updated guidance supports the use of digital and hybrid documentation systems, with a strong emphasis on risk-based data governance.
Highlights include:
This update reflects the industry’s shift toward digital-first solutions while maintaining compliance with core GMP principles.
Revised Annex 11 – Computerized Systems
Annex 11 has long provided guidance on the use of computerized systems in GMP-regulated environments. The proposed revision significantly updates this guidance to reflect advances in AI, cloud computing, and data security.
Key updates include:
This revision positions computerized systems not as auxiliary tools but as central pillars of pharmaceutical quality.
Preparing for a Digitally Mature GMP Framework
The upcoming changes to Chapter 4, Annex 11, and the introduction of Annex 22 signal a clear regulatory shift toward a digitally mature, technology-forward GMP framework.
Get Involved: Help Shape the Future of GMP
This public consultation offers a unique opportunity for stakeholders to influence the direction of GMP regulations. Take the time to review the proposed changes and submit your feedback by 7 October 2025.
Staying engaged now will make it easier to adapt and stay compliant once these updates are finalized.
Keep an eye on the Q-support channels, as the key changes will be explained as soon as the three new documents are published.
By Sandra Hillaert
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