14/15 June 2021
The MHRA´s Good Pharmacovigilance Practice (GVP) inspectorate recently published their latest inspection metrics for the period from April 2018 to March 2019. Since starting in 2009, the pharmacovigilance inspections metrics have been carried out annually.
During the reporting period 18 inspections of marketing authorization holders (MAHs) were carried out. The report contains data relating to all 18 inspections conducted. As in previous years, MAHs were selected for inspection using a risk-based approach in accordance with GVP Module III.
Of the 18 inspections conducted, two inspections were triggered by critical findings from previous inspections and 16 inspections were carried out in line with the routine national or EMA inspection schedule. Nine of those were inspections of MAHs that had never been inspected before by the MHRA. The remaining seven inspections were routine re-inspections of MAHs.
Nine inspections included a remote inspection element. For four of those inspections, office-based inspection (OBI) days were planned and conducted prior to the onsite inspection. For six inspections ad hoc OBI days were conducted after the onsite inspection (for example to review additional documents for significant inspection findings or documents that were not readily available during the onsite inspection). One of the 18 inspections was conducted entirely remotely.
A total of four critical, 78 major and 38 minor findings were identified during this period. Two critical findings were issued in relation to risk management, one critical finding was reported in relation to the quality management system (QMS) and a further critical finding was made regarding the provision of information for inspections. A summary of critical findings is presented below.
The full metrics report is available on GOV.UK.