Governing AI in Pharmaceutical Operations: How to decide what AI may do and whether people can use it reliably

Version 3.0 of this working paper presents the AI-Supported Work Authorization Cycle for deciding whether a defined pharmaceutical AI workflow may proceed, under what conditions, on what evidence, and what finding requires restriction or withdrawal. It adds a worked Stage 3 acceptance criterion, a filled fictional-manufacturer Gate Decision Record, a consolidated first-appearance source list, and a fictional worked example. Supporting templates are available at https://www.gxpframe.com/governing-ai/.