MHRA's GCP Inspection Metrics

The MHRA recently published their 'GCP Inspections Metrics Report', covering the period from 1 April 2019 to 31 March 2020.

The following GCP inspections were conducted during this period:

• In the UK: 11 sponsor (4 non-commercial / 7 commercial), 5 CRO, 12 investigator site, 4 Phase I Unit, and 10 GCP laboratory (UK laboratory facilities conducting clinical trial sample analysis) inspections;
• Outside the UK: 4 Bioequivalence (BE) inspections;
• 2 triggered inspections (for example in response to a serious breach report or an identified concern): one each at a commercial sponsor and a UK Phase I Unit.

Overview of Observations

The MHRA GCP inspectors have reported the following observations:

• Commercial sponsors: 4 critical, 17 major, 34 other. All critical observations were related to pharmacovigilance (PV).
• CROs: 4 critical, 25 major, 41 other. Critical observations were related to data integrity, IMP management, and protocol compliance.
• Non-commercial sponsors: 4 critical, 12 major, 26 other. Critical observations were related to clinical sample analysis, data integrity, sponsor oversight, and PV.
• Phase I Units: 1 critical, 8, major, 28 other. The critical observation was related to dose escalation.
• Investigator Sites: 0 critical, 17 major, 64 other.

More detailed information about the MHRA´s expectations in GCP inspections and recent observations can be found at MHRA´s Official Statistics Good clinical practice inspection metrics website.