MHRA sets standards for AI use in GxP inspection responses

30th June 2026

Summary: The MHRA Inspectorate has set out expectations for organisations using AI to prepare responses to GxP inspection findings, after seeing submissions with non-existent guidance references, inappropriate regulatory citations, inaccuracies and material that failed to address serious deficiencies. The blog says AI can support drafting, consistency and innovation, but all submissions must remain factually accurate, verifiable, technically reviewed by experienced people, signed off by accountable individuals and supported by evidence. Voluntary disclosure of AI use is encouraged, including identifying AI-assisted sections and confirming human verification, while poor-quality, inaccurate or overly generic responses may be rejected, returned for revision, treated as a sign of higher inspection risk or escalated for regulatory action. 

Link: https://mhrainspectorate.blog.gov.uk/2026/06/29/use-of-ai-for-gxp-inspection-responses-setting-standards-without-stifling-innovation/

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