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A Practical Guide to PSMF Maintenance

The Pharmacovigilance System Master File should describe your PV system as it runs today. Here is how to keep it that way.

Blog6 min read

An out-of-date PSMF is a frequent inspection finding. Treating it as a living document, with clear owners and review triggers, keeps it accurate without a last-minute scramble.

Build a maintenance routine

  • Assign an owner for each PSMF section and annex
  • Define change triggers such as new partners, systems or products
  • Keep a logbook of changes with dates and reasons
  • Schedule a full review at least once a year

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