Acting as a MHRA Approved Compliance Monitor for GDP

Recommendation

13/14 December 2023

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The Medicines and Healthcare products Regulatory Agency (MHRA) began a pilot programme for monitoring GMP and GDP activities whereby approved consultants, so-called Compliance Monitors (CM), will supervise the completion of an agreed Compliance Protocol (CP).

Background and Overview of the CM Process

You could already read about a compilation of detailed information on the background and an overview of the process in our news  "MHRA introduces external consultants as Compliance Monitors in Companies".

Compliance Monitor (CM) Application Form

The MHRA points out that consultants applying for this programme will be assessed based on the principles of eligibility and suitability.

CM eligibility includes:

• At least five years of experience performing independent audits of GMP/GDP companies;
• Not having been personally the subject of MHRA regulatory action and/or significant adverse findings in the previous three years.

Concerning the CM suitability for the GDP area, sufficient experience of the distribution activity being carried out is required.

Consultants interested in being named as eligible to act as a CM for GDP (or GMP) have to fill out the MHRA "Compliance Monitor (CM) Application Form".

Further details on the process and the requirement are provided in a MHRA Guidance.