A veterinary pharmacovigilance inspection is not a document review. It is an attempt to establish whether the system described on paper is the system that actually operates. Companies that prepare by tidying their files usually pass the first hour and struggle with the rest. The ones that prepare by testing their own processes tend to find the day uneventful.
The master file is the starting point
The pharmacovigilance system master file is where an inspector begins, because it is the marketing authorisation holder’s own description of its system. The guidance on veterinary good pharmacovigilance practices expects the master file to cover the quality management system supporting pharmacovigilance: standard operating procedures, subcontracted activities, adverse event and signal management, risk management, communication, training, documentation management, performance monitoring, change control, auditing and corrective actions.
The test applied to it is consistency. Does the master file describe what people actually do? Is it current? Does it account for every party involved, including service providers? A master file that was accurate two reorganisations ago is a finding waiting to happen.
What inspectors probe
- Case intake and timeliness. Can you show that adverse event reports were captured and reported within the expected timeframes, regardless of seriousness? Expedited reporting is a recurring focus.
- Signal management in practice. Not the procedure, the evidence. Which signals were reviewed, on what data, by whom, with what conclusion and what follow-up.
- Use of sales data. Signal management must take account of all relevant data the holder can reasonably be expected to be aware of, including sales data. Inspectors check whether it genuinely is.
- The qualified person. Their access, their authority, their knowledge of the portfolio and their availability.
- Oversight of subcontractors. Contracts, defined responsibilities and evidence that oversight is exercised.
- Training records. Including for commercial and field staff who may receive adverse event information.
- Audit and CAPA. Whether internal audits find anything, and whether findings actually close.
Self-testing before the inspection
The most useful preparation is a small number of end-to-end traces. Pick a handful of cases and follow them from the original source through intake, assessment, database entry and reporting, checking dates at each step. Pick a signal and reconstruct the decision trail. Pick a subcontracted activity and ask for the evidence of oversight. Where a trace breaks, you have found what the inspector would have found, with time to fix it.
A realistic view of findings
Few systems are perfect and inspectors do not expect perfection. What damages a company is not a defect but an undetected defect, because it implies the quality system does not work. A known issue with a documented corrective action in progress is a materially better position than a clean file that turns out to be incomplete.
How PQRA helps
PQRA prepares veterinary marketing authorisation holders for pharmacovigilance inspection: mock inspections, master file review and remediation, end-to-end process tracing, audit of subcontracted activities, and support during and after the inspection itself, including CAPA design and closure.
To prepare for a veterinary pharmacovigilance inspection, contact PQRA.
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