MHRA´s Pharmacovigilance Inspection Metrics

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.

Remote Inspections

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.

Critical findings

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 data reviewed during the inspection indicated that a large number of batches had been QP certified with patient information leaflets (PILs) which had been superseded.
  
  
• The MAH had failed to take appropriate actions to ensure that all pharmacies dispensing the company’s product were monitoring adherence with mandated additional risk minimization measures (aRMM).
  
  
• Inspectors were unable to verify compliance of critical pharmacovigilance (PV) activities due to a number of ongoing deficiencies in the PV System. Some of these had been identified by the MAH either prior to inspection announcement or during inspection preparation and concerned, for example, 
  - data integrity and management of PV data,
  - the MAH’s ability to systematically track and implement CAPAs resulting from audits and inspections,
  - the oversight and compliance management of key PV service providers, key performance indicators and written procedures.
  
  
• Data provided to inspectors in the form of line listings from the safety database was incomplete and contradictory. Without the ability to verify the data in the database, inspectors were unable to satisfactorily assess compliance of other critical PV activities like, for example, management, assessment and reporting of individual case safety reports, the completeness and accuracy of PSURs, and ongoing safety evaluation activities.

The full metrics report is available on GOV.UK.