How Often Should a PSMF be Reviewed?

To allow historical reconstruction and demonstrate an auditable change history To permit staff to overwrite obsolete content without approval To avoid approving the current PSMF To replace the need for a version history register

Quarterly reviews are prohibited under EU pharmacovigilance requirements A significant change may occur shortly after the review and remain unrecorded for months Quarterly reviews are relevant only to clinical trial systems The PSMF may be reviewed only by an external auditor

Annual review only, with no change-control process Immediate updates for material changes plus scheduled periodic reconciliation Inspection-driven updates plus informal email notifications Updates only when the PSMF owner changes

Review it only immediately before a regulatory inspection Review it at a legally fixed interval that applies uniformly to all organisations Maintain it continuously so that it reflects the pharmacovigilance system as it operates in practice Review it only when the QPPV requests a document change

Percentage of ICSRs submitted within applicable regulatory timelines Number of employees in the marketing department Annual product sales growth Number of pages in the PSMF

Storing evidence in unindexed personal folders Using unique evidence identifiers and cross-references in the PSMF index Providing only verbal explanations of system processes Replacing older evidence whenever a new document is issued

Delete the vendor section from the PSMF Update the PSMF only after the next routine review Assess and document the impact, update relevant content and track corrective and preventive actions Transfer all QPPV responsibilities to the vendor

It confirms that every typographical change requires a regulatory submission It provides documented confirmation that the revised PSMF has been reviewed and accepted under the governance process It allows the QPPV to delegate all regulatory accountability permanently It removes the need to record the change summary

Ignore document control because the content is editorial Process it under the organisation's controlled versioning procedure and preserve the audit trail Treat it as a new QPPV appointment Delete the prior PSMF version

Only the names of employees who have attended PV training Delegated tasks, responsible individuals, limits, effective dates and revocation status The commercial performance of each vendor The complete history of every individual case safety report