MHRA introduces external consultants as Compliance Monitors in Companies

Recommendation

15-17 May 2024
Berlin, Germany

The GMP-Auditor
Initial and Continuous Professional Training for GMP Auditors

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has started to pilot a new so-called Compliance Monitor Process for appropriate GMP and GDP Inspection Action Group (IAG) cases.

The current process of monitoring companies under the IAG can lead to frequent on-site inspections, which in turn significantly increases MHRA's use of resources and therefore has a direct impact on the delivery of the statutory, routine, risk-based inspection programme.

Now the MHRA has launched a pilot programme for monitoring GMP and GDP improvements. This will be done through approved consultants called Compliance Monitors (CM). The CM will work with the company to implement the measures set out in a Compliance Protocol (CP) agreed with the MHRA. The MHRA will be informed of progress in complying with the CP at a pre-agreed frequency.

Upon completion of the CP, the CM notifies the MHRA that the company is ready for an inspection. The MHRA then conducts an inspection to determine whether the firm can be released from continuing IAG oversight.  However, the MHRA reserves the right to conduct inspections prior to the completion of the CP if deemed necessary.

Overview of the CM process

The company should benefit from being able to focus on implementing the required improvements without having to divert its resources to MHRA supervisory inspections to assess remedial actions.

The MHRA can focus its resources on implementing the routine risk-based inspection programme to ensure patient safety.

The CM is selected by the company from an MHRA CM register and then works with the company to implement appropriate CP measures. Consultants applying for this programme are assessed and approved by the MHRA according to defined principles.

The company is responsible for updating and reporting on the CP on an ongoing basis. The CM then determines when the CP is completed and the firm is ready for MHRA inspection.

The MHRA has published further details of the procedure, MHRA training and relevant documentation on a separate website.

Source: MHRA Blog Part 1 and Part 2