From April 2022, the MHRA has been developing a pilot programme for GMP and GDP remediation supervision by eligible consultants acting as Compliance Monitors (CM) on behalf of companies that have been referred to the Inspection Action Group (IAG) following critical inspection deficiencies raised at an inspection. The CM will work with the company to deliver actions identified in a Compliance Protocol (CP), that has been agreed with the MHRA. High-level updates on progress against the CP will be communicated to the MHRA at a pre-agreed frequency by the CM.
Upon completion of the Compliance Protocol, the Compliance Monitor will communicate to the MHRA that the company is ready for inspection. The MHRA will then carry out an inspection to determine if the company can be removed from IAG oversight. The MHRA will maintain the right to carry out inspection(s) prior to the completion of the CP if considered necessary.
The anticipated benefits are that:
- The company will benefit from being able to concentrate on the delivery of the required improvements without having to divert their resources to manage MHRA supervision inspections to assess compliance remediation activities.
- The MHRA can concentrate resources on delivery of the routine risk-based inspection programme to ensure patient safety.
- Patients are put first by minimising potential shortages in supply of safe medicines, through the use of risk-based supervision and monitoring.
The MHRA Compliance Monitoring programme has screened and approved a number of Compliance Monitors based on their experience and independence.
ProPharma Group is pleased to announce that Dr David Crome has been deemed eligible by the MHRA to act as a Compliance Monitor in the MHRA’s compliance monitor programme for GMP and GDP remediation supervision activities.
Contact us to share more about your compliance needs.
