EU GMP Annex 22: Artificial Intelligence in Pharmaceutical Manufacturing

Machine learning already inspects your syringes, classifies your deviations and predicts your yields. Regulators have caught up: draft Annex 22 is the first EU GMP text written for artificial intelligence, and the FDA has already issued a warning letter over AI-generated GMP records. A model never tested on independent data, against predefined criteria, is an unvalidated system. An untested model is an inspection finding. This two-hour online training makes your teams Annex 22-ready: scope, test, operate.

Across ten hands-on lessons, this certified course covers every section of the draft annex with seven real cases, from the scope tests and the annex’s place beside Annex 11, the EU AI Act and FDA expectations to the change control and monitoring of a deployed model. Its traceable certificate gives you audit-ready proof that you, or your team, are ready to apply Annex 22 in GMP practice.

Why teams choose this course

• Built by computerised system validation and AI governance experts
• Covers every section of the draft annex, from scope to operation
• Real cases: the Purolea warning letter, the Epic sepsis model, Amgen’s deep learning inspection
• Written on the July 2025 draft, with a lesson on absorbing the final text
• One-year access per learner and a CPD/CEU certificate your QA can verify online

What you’ll learn

• Decide which AI use cases fall under Annex 22 and which model types are permitted
• Write an intended use that defines the input data, its subgroups and its limits
• Set acceptance criteria at least as high as the process the model replaces
• Build a test dataset that is representative, correctly labelled and independent of training
• Apply the explainability and confidence requirements to a classification model
• Keep a deployed model under change control, monitoring and human review
• Build the AI inventory, gap analysis and model file an inspector will ask for

Who should enroll

• Quality assurance and validation teams
• Production, quality control and process experts
• IT, automation and data science teams
• Regulatory professionals and suppliers of AI-enabled equipment and software

Upon successful completion, each learner receives a validated certificate accredited with CPD/CEU credits, suitable for audit and compliance documentation.

Curriculum

Lesson: A Brief History of Trusting Software in GMP

Lesson 1: Annex 22 in Context: Status, Legal Standing and the Regulatory Family

Lesson 2: Scope: Critical Applications and Permitted Models

Lesson 3: Principles: People, Documentation and Quality Risk Management

Lesson 4: Intended Use and the Input Sample Space

Lesson 5: Test Metrics and Acceptance Criteria

Lesson 6: Test Data: Selection, Labelling and Independence

Lesson 7: Test Execution: Plan, Deviations and Documentation

Lesson 8: Explainability and Confidence

Lesson 9: Operation: Change Control, Monitoring and Human Review

Lesson 10: Implementing Annex 22 and Preparing for Inspection

Conclusion

Glossary

Final Assessment