How Often Should a PSMF be Reviewed?

Record the deputy only in an informal team email Update the delegation and deputy information promptly, including competence and contact details Wait until the next inspection to add the deputy Remove the QPPV's details from the PSMF

The PSMF has not changed for five years despite several restructures The PSMF is updated after material changes, periodic reviews reconcile it with practice, and evidence is readily retrievable The organisation performs a review only when inspectors request it The PSMF contains extensive narrative but no supporting records

Only the central office's activities, because affiliates are outside the PV system The oversight model, reporting lines, local variations and controls that provide assurance across affiliates That all affiliates use identical procedures regardless of local requirements That affiliate responsibilities can remain undocumented if contracts exist

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

Checking only whether the document has a title page Reconciling QPPV arrangements, governance documents, vendors, systems, KPIs, training and inspection evidence against current practice Replacing all PSMF evidence regardless of whether it remains current Reviewing only the organisation's commercial strategy

A change to the vendor's office décor A new PV vendor relationship or a material change to contracted PV activities A vendor employee's annual holiday schedule A change to the vendor's corporate logo

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

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

They demonstrate that performance is monitored proactively and that issues are acted upon They are required only to calculate product sales forecasts They eliminate the need for audits They show that no pharmacovigilance deviations can occur

It replaces all pharmacovigilance SOPs It identifies who is responsible, accountable, consulted and informed for key activities It proves that all cases were submitted on time It serves as a substitute for a vendor contract