# Compliance Monitor (CM) Overview and Application Process

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/c716e25e-424c-4b2e-b186-b9a31bb1c02c
Type: Guidance
Published: April 29, 2022
Updated: June 15, 2022

> Starting in April 2022, the UK Medicines and Healthcare products Regulatory Agency (MHRA) initiated a pilot program for companies failing to meet Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards. This guidance addresses firms referred to the Inspection Action Group (IAG) after inspections reveal significant non-compliance that triggers formal escalation. While the document describes a general regulatory framework rather than a specific enforcement action against a single company, it outlines the path for entities struggling with manufacturing and distribution quality standards. Under this pilot, eligible companies are offered the opportunity to work with independent Compliance Monitors (CM) to oversee a structured Compliance Protocol (CP). This protocol serves as a roadmap for required actions, focusing on remediating corrective issues and ensuring a safe supply of medicines. Participation allows firms to benefit from intensive, independent oversight while the MHRA focuses its resources on broader inspection programs. Companies may choose to decline this route and remain within the standard IAG enforcement process. The ultimate goal of the initiative is to reduce the risk of drug shortages and enhance patient safety by accelerating the remediation of systemic quality failures through expert third-party monitoring.

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## Content

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.

## Attachments

- [Compliance Monitor (CM) Overview and Application Process](/government/publications/compliance-monitor-cm-overview-and-application-process/compliance-monitor-cm-overview-and-application-process)
- [Compliance Monitor application form](https://assets.publishing.service.gov.uk/media/626bef57e90e0746ca7e55c4/CM_application_form_19042022.docx)