This is the second part a two-part blog series on the Compliance Monitor Process which is being piloted by the MHRA from April 2022.
As outlined in the first part of this blog, the MHRA is starting a pilot in April 2022 whereby Compliance Monitors (CM) will supervise the completion of an agreed Compliance Protocol (CP) for eligible Inspection Action Group (IAG) cases. It is common for companies that are at IAG to employ consultants to assist with remediation activities. Our pilot for the compliance monitor process will establish a framework for the CM to carry out the remediation work but also report on progress to the MHRA. This second blog provides details on the CM role and application process.
The CM, selected by the company from the CM register and accepted as suitable by the MHRA for that case, will work with the company to deliver the CP actions.
- The CMs minimum time will on the project be defined and agreed in the CP.
- They will either be directly involved in the remediation actions, or, assess appropriate completion of the activities that are being completed by others.
- The company are responsible for providing an update against the CP at an agreed frequency, with the CM signing the document to confirm its accuracy. The CM should only sign the document if it is factually correct.
- Note: The periodic report will be short and only communicate exceptions to the agreed timelines, or where significant related compliance issues were identified. This will allow the company and CM more time to focus on delivering the CP actions.
- The CM will determine when the CP has been completed and the company is ready for MHRA inspection.
To ensure a robust supervision process, consultants applying for this programme will be assessed by the MHRA based on the principles of eligibility and suitability. The eligibility for a CM to be named on the register will be based on a number of factors, including:
- At least 5 years’ experience performing independent audits of GMP/GDP companies
- Provision of a suitable CV
- Not having been personally the subject of MHRA regulatory action and/or significant adverse findings in the previous 3 years
- Completion of MHRA training on the Compliance Monitor role and expectations.
The suitability of a CM will be assessed as and when they are nominated by a company. The CM will be assessed based on the following, as a minimum:
- The CM will be required to have sufficient experience of the dosage form manufactured, testing activities being performed, or distribution activity being carried out.
- The CM will be required to submit a confirmation that there is no Conflict of Interest.
- This will include there being no financial conflict.
How to apply
Further details on the process, the MHRA training, and related documents can be found here, and we would like to invite anyone who meets the criteria, and is interested in the position, to apply.