Guidance

Compliance Monitor (CM) Overview and Application Process

summary

• From: Medicines and Healthcare products Regulatory Agency
• Published: 29 April 2022
• Last updated: 15 June 2022 — See all updates

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Compliance Monitor (CM) Overview and Application Process

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Compliance Monitor application form

MS Word Document, 842 KB

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Details

Overview

From April 2022, the MHRA will be running a pilot scheme to monitor companies that fail to comply with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) and are referred to the Inspection Action Group (IAG) after an inspection that has resulted in the compliance escalation process being initiated.

The pilot facilitates reducing potential shortages in the supply of safe medicines through the use of risk-based supervision and monitoring. The process will also assist the MHRA in concentrating resources on delivery of the routine risk-based inspection programme, thus further ensuring patient safety.

During the pilot scheme, the MHRA will review referrals to the IAG and where these referrals are considered suitable, the company may be offered the option of using Compliance Monitors (CM) to oversee the implementation of an agreed Compliance Protocol (CP). A company offered the CM oversight route may choose not to accept this and can continue with the routine IAG process.

This independent oversight from the Compliance Monitor will enable the company to focus on remediation of the corrective actions and augment the regulatory oversight of the MHRA.

Published 29 April 2022
Last updated 15 June 2022 + show all updates

1. 15 June 2022

   Under the section headed 'Eligibility', we have added the bullet point: * Reside in the United Kingdom

2. 29 April 2022

   First published.