Bridging Guidance and Regulation: Interpreting the Draft Annex 22 on Artificial Intelligence in GMP Manufacturing

Area of Science:

• Pharmaceutical Manufacturing
• Regulatory Science
• Artificial Intelligence

Background:

• The pharmaceutical industry is increasingly adopting Artificial Intelligence (AI).
• Continued Process Verification (CPV) provides a framework for AI application.
• The European Medicines Agency (EMA) has released Draft Annex 22 for AI in pharmaceutical manufacturing.

Purpose of the Study:

• To interpret EMA's Draft Annex 22 on AI within GMP-regulated pharmaceutical manufacturing.
• To examine the alignment between Annex 22 and CPV recommendations.
• To propose a roadmap for compliant AI implementation.

Main Methods:

• Literature review and interpretation of EMA Draft Annex 22.
• Analysis of alignment between Annex 22 and CPV recommendations (Stassen et al., 2025).
• Development of conceptual frameworks and workflow illustrations.

Main Results:

• Identified convergence between Annex 22 and CPV principles.
• Highlighted operational challenges in AI implementation.
• Proposed a roadmap for harmonized AI governance and compliance.

Conclusions:

• EMA Draft Annex 22 provides a risk-based framework for AI in pharmaceutical manufacturing.
• Harmonizing CPV principles with Annex 22 expectations is crucial for compliance.
• Proactive AI governance is essential for pharmaceutical sector readiness.