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publicMedicines and Healthcare products Regulatory Agency (MHRA) · United Kingdom · Updated Jun 29, 2026

Use of AI in GXP Inspection Responses

Implement mandatory quality checks and oversight for all AI-generated inspection responses to meet MHRA expectations for accuracy.

Inspection ReadinessCAPARegulatory Intelligence Lead

SOP Impact2 SOPs

Relevant for: Regulatory Intelligence Lead, PV Quality Lead

verifiedRegulatory action: Guidance / Notice

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Digest roles: QPPV. Work email only · workflow Inspection Readiness