Guidance

Formulating responses to GCP inspection findings

How to respond to the GCP inspection report findings, increase awareness of the GCP Inspectors’ expectations and aid formulation of an acceptable response.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 28 April 2026

Documents

Formulating responses to GCP inspection findings

PDF, 170 KB, 4 pages

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Details

The GCP Inspectorate have assessed many responses to GCP inspection reports. Responses that require amendment/clarification lead to additional time spent by the inspector and the inspected organisation in order to close the inspection. This document aims to give assistance in how to respond to the GCP inspection report findings, increase awareness of the GCP Inspectors’ expectations and aid formulation of an acceptable response.

Published 28 April 2026