Specialty & Emerging

Artificial Intelligence in GMP Manufacturing

The 2026 FDA/EMA joint AI Guiding Principles, the draft EU GMP Annex 22, and what GxP model validation and governance now require.

What this course covers

This course covers the 2026 FDA/EMA joint AI Guiding Principles and what they expect from a pharmaceutical quality system, what the draft EU GMP Annex 22 proposes for AI use in GMP manufacturing, validation expectations for AI and machine learning models used in GxP-relevant decisions, and documentation and change control considerations specific to models that update over time.

Who this course is for

QA and regulatory affairs staff building AI governance into the quality system
IT governance staff overseeing AI tools used in or adjacent to GxP processes

What you'll learn

The 2026 FDA/EMA joint AI Guiding Principles and what they expect from a pharmaceutical quality system
What the draft EU GMP Annex 22 proposes for AI use in GMP manufacturing
Validation expectations for AI and machine learning models used in GxP-relevant decisions
Documentation and change control considerations specific to models that update over time
Lessons from recent AI-related warning letters

Why it matters

Ten joint principles from FDA and EMA and a binding draft Annex mark the point where AI governance stopped being optional guidance and started becoming an inspectable expectation. Sites already using AI tools in any GxP-adjacent capacity need a governance framework now, not once the Annex is finalized.

Included in the full GMPify subscription

Completion certificate, PDF slide download, and access to the complete GMP course library from day one.

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