WHITE PAPER · 12 PAGES · PDF
EU GMP Annex 22 and AI in Pharma and Biologics
Explore draft EU GMP Annex 22 AI guidelines for pharma and biologics, scientific models, explainability and meaningful human oversight.
Written for Biologics executives, MSAT, process development, Quality, regulatory and digital leaders.
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INSIDE THE WHITE PAPER
Move from interest to a reviewable decision.
Understand the draft scope for static, repeatable ML and its restrictions on critical GMP uses.
Separate the published consultation draft from subsequent EMA workshop discussion.
Map intended use, acceptance criteria, independent testing, explainability and lifecycle evidence.
Evaluate process optimization, quality prediction and investigation workflows for their actual decision role.
What you’ll find inside
- Executive summary
- Annex 22 guidelines on AI and the boundary for GMP use
- AI in biologics using modality specific scientific models
- AI in pharma for process optimization quality prediction and deviation investigation
- Agentic AI in pharma with human oversight
Includes an executive summary, practical decision tools, primary references and a next-step workflow review.
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