MHRA GCP Inspections Metrics Report: 1st April 2017 – 31st March 2018

On 4 May 2020 the UK MHRA issued the GCP inspection metrics report covering the period 1st April 2017 to 31st March 2018.

During the Metrics Period a total of 88 GCP Inspections were undertaken by the MHRA GCP Inspectorate. The types of inspections and findings are presented below.

A total of 12 commercial sponsors were inspected and all have been reported. All these inspections were systems inspections. Of the 12 inspections, 3 (25.0%) had at least one critical finding for Pharmacovigilance, False and Misleading Information and/or Data Integrity and all (100%) had at least one major and/or critical finding.

A total of 10 Contract Research Organisations were inspected and all inspections have been reported. All 10 were systems inspections. Of the 10 inspections, 0 (0.0%) had critical findings and 8 (80.0%) had at least one major finding.

A total of 12 non-commercial organisations were inspected. Of the 12 inspections, 3 (25.0%) had at least one critical finding for Investigational Medicinal Products, Clinical Trial Authorisation or GCP Compliance and 12 (100.0%) had at least one major and/or critical finding.

A total of 9 inspections were done of Commercial Phase 1 Units/Clinical Research Units, 2 inspections were of the same organisation that had one report. Eight of the inspections were routine inspections for the MHRA voluntary phase 1 accreditation scheme and 1 was a systems inspection. None of the inspections were triggered.

Of the 8 reported inspections, none (0%) had a critical finding and 4 (50.0%) had at least one major finding.

A total of 17 investigator sites in the UK were inspected and all were as an associated site with a sponsor/CRO/non-commercial/CTU inspection. Of the 17 inspections, 1 (5.9%) had a critical finding for Data Integrity and 11 (64.7%) had at least one major finding.

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