Compliance Monitor Process (Part 1) – An Introduction

On 11 March 2022 the MHRA Inspectorate Blog published part one of a two-part series on the Compliance Monitor Process.

From April 2022, the MHRA will begin a pilot program for GMP and GDP remediation supervision by eligible consultants acting as Compliance Monitors (CM). The CM will work with the company to deliver actions identified in a Compliance Protocol (CP), that has been agreed with the MHRA. High-level updates on progress against the CP will be communicated to the MHRA at a pre-agreed frequency (provision of additional detail will be by exception against the CP requirements).

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