Advisor 462

CLINICAL RESEARCH • CLINICAL QUALITY ASSURANCE

Frequency of MHRA GPvP inspection findings unchanged Annual inspection metrics from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) Good Pharmacovigilance Practice (GPvP) Inspectorate suggest that the overall number of inspection findings per inspection continues to plateau.

Types of inspection The 18 inspections comprised • two inspections triggered by critical findings from previous inspections • 16 inspections scheduled and conducted in line with the routine national or EMA inspection schedule – nine were of MAHs that had never been inspected by the MHRA before, and seven were routine re-inspections of MAHs. Nine inspections included a remote inspection element. For four of these, office-based inspection days were planned and conducted prior to the on-site inspection. For six inspections, ad hoc office-based inspection days were required after the on-site inspection (eg. to review additional documentation for significant inspection findings or documentation that was not readily available during the on-site inspection). One inspection was conducted entirely remotely as part of a pilot project on office-based GPvP inspections. Overview of findings Four critical, 78 major and 38 minor findings were identified (Table 1). Overall, the average number of findings per inspection (all grades) for the 12 months to 31 March 2019 has remained relatively stable when compared with previous reporting periods and currently stands at 6.7. However, the average number of critical and major findings per inspection increased slightly from the previous 12-month period, while the average number of minor inspection findings fell from 3.14 to 2.11. The report includes a graph of the average number of inspection findings by type reported per inspection over time, going back as far as 2006. It indicates that the average number of critical findings has remained relatively constant throughout the

On 15 April 2020, the MHRA GPvP Inspectorate published its latest annual Pharmacovigilance Inspection Metrics

Report. A total of 18 inspections of marketing authorisation holders (MAHs) were conducted by the Inspectorate from April 2018 to March 2019, compared with 22 in the previous 12-month period. The purpose of the inspections was to examine compliance with existing EU and national pharmacovigilance regulations and guidelines; the metrics published by the Inspectorate relate to all 18 inspections. As in previous years, MAHs were selected for inspection using a risk-based methodology, in accordance with Good Pharmacovigilance Practice Module III. The national inspection programme for this reporting year also took into account the European Medicines Agency’s (EMA’s) programme of routine pharmacovigilance inspections of organisations with centrally authorised products. Factors considered in the risk-based approach include • product-specific risks (eg. new active substances or new biological products) • the complexity of the pharmacovigilance system • the complexity and size of the organisation(s) involved in the pharmacovigilance system, including service providers • the compliance and inspection history of an organisation. Findings identified during inspections were graded as critical, major or minor (definitions of these terms are provided in Appendix 1 of the metrics report). Below we summarise the number of inspection findings; in future articles we will examine the nature of these findings.

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Issue 462, 2020

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