Compliance Monitoring Process – from April this year the MHRA are piloting a different approach to the monitoring of companies that are referred to the MHRA’s IAG (Inspection Action Group) for failure to comply with the standards of Good Manufacturing Practice or Good Distribution Practice.
Instead of the MHRA overseeing the remediation process, the new Compliance Monitoring Process will allow companies placed in IAG to select an MHRA approved consultant to act as the Compliance Monitor. The Compliance Monitor will then be responsible for monitoring the Company’s performance against the Compliance Protocol which will have been previously agreed between the Company, the MHRA and the Compliance Monitor.
The Compliance Monitor will then work with the company to ensure delivery of the agreed Compliance Protocol and approve periodic updates confirming the implementation of the corrective actions are on schedule. The Compliance Monitor will also have the right not to approve the update if they do not believe that the information being presented is an accurate reflection of the Company’s state of compliance. The Company will be responsible for paying the Compliance Monitor fees.
Once the Compliance Monitor has confirmed that the requirements of the Compliance Protocol have been fulfilled, the MHRA will then perform another inspection. If compliance is then confirmed the inspector will recommend to the IAG that the referral is closed. The MHRA will, however, reserve the right to carry out additional inspections before completion of the Compliance Protocol if considered necessary.
In order for a consultancy to be involved in the MHRA’s new Compliance Monitoring Process, the individual consultant involved must meet the required eligibility criteria, which includes at least five years’ experience of carrying out independent GMP or GDP audits.
To see the full list of eligibility criteria and for further information on the MHRA’s new Compliance Monitoring Process follow the link below.
Obviously it is better for companies to avoid being referred to the IAG in the first place. PCL’s team of experienced RP consultants are experts in performing GDP GAP Analysis and pre-inspection audits to help prevent any unexpected and undesirable outcomes from your next MHRA inspection.
Please see the link below for further details: https://www.pharmacyconsulting.co.uk/consultancy/pharmaceutical-wholesalers/external-audit-mock-inspection/