A pharmacovigilance inspection checks whether your safety system works the way your procedures say it does. The best preparation is a system that is kept in good order all year, but there are practical steps that make a real difference in the weeks before an inspector arrives.
1. Bring the PSMF up to date
The Pharmacovigilance System Master File is usually the first document requested. Check that it reflects your current organisation, products, service providers, databases and procedures, and that its annexes are complete.
2. Review your procedures against what people actually do
Inspectors compare standard operating procedures with daily practice. Walk through case processing, literature screening, signal management and reporting, and close any gaps between the written procedure and the work.
3. Check timelines and reconciliation
Late reports are among the most common findings. Review reporting compliance for expedited cases and periodic reports, and make sure reconciliation with partners, medical information and quality complaints is documented.
4. Confirm training records
Everyone with a pharmacovigilance responsibility should have a current, documented training record, including staff outside the safety team who may receive adverse event reports.
5. Run a mock inspection
An independent audit or mock inspection shows you what an inspector will see while there is still time to correct it. Insight’s audit team runs full system audits, risk-based audits and pre-inspection support for companies across Egypt and the region.