MHRA Compliance Monitor (CM) programme – Inspection readiness – part 2

In April 2022 the MHRA introduced Part 1 of a  programme to improve the supervision of appropriate companies who are at Inspection Action Group (IAG) stage to assist with inspection readiness whereby Compliance Monitors supervise the completion of an agreed Compliance Protocol for eligible IAG cases.

Part 2 of the programme was released in May 2022, and focuses on the selection criteria for Compliance Monitors, who are selected by the concerned company from a CM register (once selected as suitable by the MHRA for the specific case) to work together with the company to deliver the compliance protocol actions.

The MHRA will base their criteria for CM eligibility on the following;

  • 5 years independent auditing of GMP/GDP facilities
  • Suitable CV
  • No MHRA regulatory actions / significant adverse findings that are personally attributable within the last 3 years
  • Satisfactory completion of CM training

There must be a formal confirmation of no conflict of interest, including financial conflict and the CM must have sufficient experience of the dosage form being manufactured, testing activities being performed or distribution activities being carried out.

The benefit of this two-stage approach is that it will help to ensure CMs have the background experience and site-specific knowledge to assess risks to product quality and patients in developing and overseeing remediation plans and assisting with implementation and has been reflected that it draws parallels with the naming of Qualified Persons (QPs) on UK manufacturing licences.

Source: MHRA Inspectorate Blog

Our Quality team have experience preparing for and hosting MHRA inspections and can ensure that both your site and staff are inspection ready. Post-inspection, we can help address any deficiencies raised and support you with MHRA responses, until the licence is granted. Get in touch at

Claire Crewe
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