MHRA Guidance on Responding to a GLP & GCP Laboratories Inspection Report

On 30 March 2021 the UK MHRA published the guidance for industry on preparing responses to GLP and GCP inspection reports.

This guide has been provided to assist in preparing responses to Inspection Reports. This format is not mandatory but is the inspectorate’s preferred method for providing responses and should help to reduce the time taken to reach a compliance decision after the inspection. The guidance is presented in the same format as the deficiency annex to GLP & GCP laboratory inspection reports.

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