Within 30 working days of the end of the MHRA inspection, the MHRA will issue a report to the Sponsor and they will categorise their findings into three areas such as Critical, Major and/or Other. The MHRA will expect responses to be received within 30 calendar days of despatch. The response to the MHRA will be managed by RACD. Once the MHRA are satisfied with our response, they will issue a summary letter and an inspection certificate.
Types of Findings
‘Critical’ Finding –defined as one where:
- Evidence exists that the safety, well being or confidentiality of trial subjects has been (or has significant potential to be) jeopardised, and/or,
- Serious doubt exists relating to the accuracy or credibility of trial data.
The Implication of a ‘Critical’ finding requires an agreed remediation plan to be put in place so that a re-inspection can occur.
‘Major’ Finding- a non-Critical finding that:
- Reveals a significant and unjustified departure from the UK regulations or,
- Consists of a number of minor departures from the UK regulations or other relevant established guidance, suggesting a systematic quality assurance failure, and/or,
- Reveals a failure to comply with relevant legislative requirements.
The implications of a ‘Major’ finding means that these must be addressed but the organisation can suggest to the MHRA how this is to be achieved.
‘Other’ Finding- includes:
- Any other inspection finding, including observations and recommendations.
‘Other’ findings do require remedy where this is possible, and preventative actions should always be considered. Response to other findings will be requested in the inspection report. Observations and recommendations do not require written response unless requested by the Inspector in the inspection report.
What are the common findings from MHRA inspections?
The Common Findings Risk Assessment (CFRA) Form is based on ‘How to prepare for an inspection on GCP by the MHRA: a guide for NHS organisations that Sponsor or host clinical trials of medicinal products’. The form is based on common findings and interview questions, reported from MHRA inspections and thus allows areas of risk to be readily identified. It is advised that you use this form to identify areas of weakness within your CTIMP.