EU Annex 22 Draft (AI in GMP) Explained | EudraLex Vol. 4 2025 Update

EU Annex 22 Draft (AI in GMP) Explained | EudraLex Vol. 4 2025 Update

The European Medicines Agency (EMA) has released a new draft Annex 22 in EudraLex Volume 4, focusing on the use of Artificial Intelligence (AI) in GMP environments.

In this video, we break down:    • EU Annex 22 Draft (AI in GMP) Explained | ...  
✅ What Annex 22 covers (AI/ML in pharma manufacturing & quality)
✅ How it compares to Annex 11 & Chapter 4
✅ Key compliance requirements – scope, acceptance criteria, explainability
✅ Industry impact & implementation strategies
✅ What pharma companies must prepare for inspections

Whether you’re a QA professional, regulatory specialist, or pharma student, this video will help you understand how Annex 22 ensures quality, data integrity, and compliance in AI applications.

📌 Don’t forget to subscribe to ‪@Pharmalytics‬ for more updates on EU GMP guidelines, USP chapters, and pharma career growth.

Timestamps
0:00 – Hook: Why AI in Pharma Needs Regulation
0:30 – Introduction to Annex 22 Draft
1:00 – Scope & Principles
2:00 – Intended Use & Documentation
3:00 – Acceptance Criteria & Validation
4:00 – Test Data & Explainability
5:30 – Operation & Lifecycle Monitoring
6:30 – Old vs. New: Annex 11 vs. Annex 22
7:30 – Implementation & Industry Impact
8:00 – Summary of Annex 22 Key Points
8:45 – Outro & Key Takeaways

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