The European Commission has officially launched a stakeholders’ consultation on updates to EudraLex Volume 4 GMP Guidelines, focusing on Annex 11 on Computerised Systems, and the completely-new Annex 22 on Artificial Intelligence (AI).
In our rapidly evolving pharmaceutical landscape, digital technologies and AI are reshaping how we deliver safe, high-quality medicines. These guideline adaptations are designed to ensure regulatory clarity while promoting innovation and harmonised standards.
The updates on Annex 11 strengthens lifecycle control of computer systems, applying Quality Risk Management across the board, especially when defining system requirements, monitoring suppliers and service providers, and ensuring audit trails, e-signatures, data integrity, and security.
The new Annex 22 on AI addresses AI and machine learning in pharmaceutical manufacturing of active substances and medicinal products. It lays out clear expectations for model selection, training, validation, performance monitoring, change control, and procedures for human review when necessary.
These adaptations to the GMP guidelines taken together aim at providing a comprehensive and robust framework that supports the implementation of IT technologies in pharma manufacturing while safeguarding product quality and patient safety.
The consultation is now open (since 7 July 2025) and will close on 7 October 2025.
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