A Blueprint For GMP-Compliant Generative AI

By Valentina Armiento, Genedata

This content is brought to you by Genedata, a Danaher Operating Company.

Generative AI is moving from pilots into pharmaceutical workflows, but its adaptability is exactly what a framework built on reproducibility finds hardest to accept. Classical GMP systems return identical outputs for identical inputs. Large language models do not, and that gap shapes the current draft of EU GMP Annex 22, which is still under discussion. The analysis looks at where regulators stand and how that position may shift. It then turns to three connected ideas that determine whether GenAI can be introduced with confidence: how far a model's role is bounded, what traceability looks like for a probabilistic system, and how lifecycle control keeps updates auditable.

Read the full article to see how compliance and GenAI can work together.