Employee Responsibilities in the Use of Artificial Intelligence under EU GMP Annex 22

Under the draft Annex 22 of the EU GMP guidelines, employees must fully understand the intended use and potential risks of AI systems in manufacturing. Close collaboration with QA, IT, data experts, and consultants is essential during algorithm selection, model training, validation, and implementation. Personnel should possess appropriate qualifications, undergo regular training, and have clearly defined roles. Employees using AI-assisted decision-making must have their training and performance consistently recorded and documented. To maintain objectivity, individuals with access to test data should not participate in model training or validation unless working under dual control with an independent colleague. When AI outputs support decisions, comprehensive records and logs must be maintained. Depending on the process’s criticality and the model’s testing level, constant human review of AI outputs must be performed according to defined procedures to ensure reliability and regulatory compliance.

07-11-2025