European Commission proposes on updated GMP guidelines for AI
The European Commission wants feedback from stakeholders on updating its good manufacturing practice (GMP) guidelines in EudraLex Volume 4 to account for recent advances in artificial intelligence (AI).On 7 July, the Commission opened a public consultation for updates to EudraLex that include changes to Chapter 4 and Annex 11, and the addition of Annex 22 in the EudraLex. The new and revised documents were developed by the European Medicines Agency GMDP-Inspectors Working Group in collaboration with the Pharmaceutical Inspection Co-operation Scheme (PIC/S).
“In light of the rapid advancement of digital technologies and the implementation of AI systems in pharmaceutical manufacturing, the update of Good Manufacturing Practice (GMP) guidelines is essential to ensure that they continue to provide clear, practical and relevant guidance for manufacturers and national competent authorities,” said the Commission. “The revision of GMP Annex 11 and Chapter 4, along with the introduction of a dedicated Annex 22 on Artificial Intelligence aim at supporting innovation in the manufacturing of medicines and ensuring regulatory harmonization.”
“These 3 documents 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 Commission added.
Chapter 4 of EudraLex addresses documentation requirements for GMP. The proposed updates to the document are intended to help stakeholders comply with regulations while using new technologies, hybrid solutions, and new services when managing GMP documents. More specifically, the Commission said it is applying risk-management principles to ensure that documents in data governance systems are accurate, have integrity, are readily available, and legible regardless of the format in which they are kept.
“All documentation, whether in text, image, video, or audio form, must remain complete and readable throughout its lifecycle,” the Commission added. “The guideline also clarifies the requirements for the management of electronic records, signatures, and data integrity while ensuring consistency with the concurrent revision of Annex 11.”
The proposed changes to Annex 11 apply quality risk management (QRM) to how computerized systems are managed throughout their lifecycle. The Commission says the updates reinforce stakeholder obligations regarding the maintenance of computerized systems and oversight of suppliers and external service providers. They are also meant to enhance data integrity, audit trails, electronic signatures, and system security.
The Commission has added Annex 22 specifically to address questions regarding AI and machine learning (ML). More specifically, it provides details on requirements for AI selection, training, and validation of AI models
“Emphasis is made on the definition of the intended use of the model, the establishment of performance metrics, the quality of model training data, and the management and processing of test data,” said the Commission. “Annex 22 foresees a continuous oversight of AI systems, including change control, model performance monitoring and procedures for human review when necessary.”
Stakeholders can comment on each proposed change to EudraLex through 7 October on the Commission's website.
