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.