Dave Rushton
Founder
of Paradigm Shift Consulting Limited.
Dave Rushton is Founder of Paradigm Shift Consulting Limited, a Good Distribution Practice Consultancy.
A blog post by the MHRA (Medicines and Healthcare products Regulatory Agency) on 11 March 2022 rang in the news of a brand-new programme they intend to launch in April 2022: The Compliance Monitor (CM) pilot programme.
*UPDATE* Paradigm Shift can support with Compliance Monitors if you need. Two of our team are already approved.
The programme appears to be designed to give extra support and guidance to appropriate Good Manufacturing Practices (GMP) & Good Distribution Practices (GDP) cases that have been referred to the Inspection Action Group (IAG), by overseeing and supporting remediation of compliance concerns, whilst diverting time and resources back into the MHRA.
Compliance Monitor: How is it going to work?
1. The MHRA will be generating a register of approved consultants, who will act as Compliance Monitors. Details on the role and how to apply to become a Compliance Monitor (CM) are yet to be released.
2. When a company has a Good Manufacturing Practice or Good Distribution Practice inspection case referred to the IAG, the case will be reviewed for its eligibility to receive compliance supervision.
3. If a case is suitable to receive compliance supervision, the MHRA will supply the register of Compliance Monitors to the company. The company can then choose from the list who they wish to work with.
4. The MHRA will review the company’s selection, and providing the chosen Compliance Monitor is considered suitable for the case, they will be instructed to engage with the company. The decision on suitability will depend on the experience and skills of the selected Compliance Monitor, and what support the Company requires. The fees for a Compliance Monitor are presently stated as being paid for by the company.
5. The company, Compliance Monitor & the MHRA will agree a Compliance Protocol to remedy the compliance concerns found at inspection.
6. The Compliance Monitor will remain engaged with the company throughout the Compliance Protocol, providing support as the company work through the agreed remedial actions.
7. The Compliance Monitor will report back to the MHRA at agreed stages of the Compliance Protocol, confirming the Company’s progress. This process will free the MHRA from the need for interim supervisory visits, enabling them to refocus their resources more effectively.
8. Upon completion of the Compliance Protocol, the Compliance Monitor will notify the MHRA that the company is ready for re-inspection.
The MHRA has highlighted that they maintain the right to carry out inspections prior to the completion of a Compliance Protocol if they consider it necessary to do so, particularly in complicated cases where multiple concerns were identified.
What benefit will this offer?
The current process for monitoring the progress of remediations is for MHRA representatives to carry out supervision inspections on site. The MHRA themselves describe these inspections as “causing an interruption to resources”, which suggests that they view their current inspection process as actually slowing down the delivery of remedial actions. With that in mind, the first benefit that the MHRA is forecasting is the freedom for of companies to focus entirely on delivering the remediations that are needed, without having to divert their own resources to accommodate any possible MHRA supervision inspections.
The MHRA have also suggested that having this dedicated support team in the form of Compliance Monitors will also divert time and resources back into the MHRA, allowing them to focus on delivering their inspection programme efficiently and effectively, which is imperative to ensuring patient safety.
More details on this programme are due to be released soon.
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Source: MHRA Inspectorate Blog
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