jackprior.ai · Pharmaceutical CMC / GMP · AI

AI-in-CMC Regulatory Map

Every regulation, guidance, harmonised guideline, standard and industry paper that governs or shapes AI in pharmaceutical development, manufacturing and quality — with the model-impact tiers and change-control instruments that connect them. These are my personal working notes — public sources only, with verification marks showing what I have and have not yet checked. 85 documents, updated 18 Oct 2026. Corrections welcome: chat@jackprior.ai. Overwhelmed by the grading schemes? Start with the one-page job aid.

These documents are worked through, one question at a time, on the podcast AI in Biopharma Manufacturing: Are We There Yet?

Dated documents by year and jurisdiction. Colour is document status; hover a dot for the title, click for the full entry. Undated programs are left out.

Final / in forceDraft / discussionPlanned / expectedProgram / other
Pick a document on the timeline.

Four unified tiers keyed on the two factors nearly every framework converges on — how much the model influences the decision, and the consequence if it is wrong. Columns show where each framework's own vocabulary lands.

Which change-control instrument applies at each tier, and how the four kinds of change are handled — C1 environment, C2 deliberate model change, C3 model-directed (continuous learning), C4 third-party / foundation model.

Key concepts and where they come from

Watchlist

Open questions and gaps

    Maintained by Jack Prior as personal working notes; not regulatory advice, and no confidential or pre-publication material. Verification marks: verified checked against the web, Aug 2026; unverified from working knowledge — confirm before citing; paid member-only document, cited but not reproduced.