MHRA - Compliance Monitor (CM) Overview and Application Process

4th May 2022

MHRA - Compliance Monitor (CM) Overview and Application Process

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.

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