GVP Module III: Pharmacovigilance Inspections

A vendor contract containing general compliance language A dashboard showing the vendor's average performance only Evidence that exceptions were visible to the QPPV, escalated through governance and linked to corrective action A statement from the vendor that its processes are compliant

Whether one department has enough staff Whether a safety item can be followed through connected processes using contemporaneous evidence Whether all procedures use identical wording Whether the MAH has archived every document in one central location

Averages are never accepted as quality information A strong average can conceal overdue or otherwise high-risk individual items and important exceptions Metrics are relevant only to clinical trials Average metrics automatically prove that the PSMF is inaccurate

Triggered inspections are automatically required to examine every pharmacovigilance activity Inspectors may identify additional systemic concerns while examining the initial issue The MAH must voluntarily add unrelated processes to the inspection scope Only routine inspections are permitted to remain within their original scope

To confirm that the MAH has approved SOPs for all pharmacovigilance activities To provide independent oversight of whether the pharmacovigilance system operates effectively and protects public health To determine whether the QPPV personally performs all safety activities To replace the MAH's internal audit and quality-management processes

An action is completed ahead of schedule and effectiveness is demonstrated A CAPA action is delayed or subsequent evidence shows that it does not work as intended A finding is described in the final inspection report A process owner attends a CAPA meeting

A system with extensive documentation prepared immediately before an announced inspection A system in which procedures, people, technology, records, quality controls and governance consistently support and demonstrate effective operation A system in which the QPPV personally controls every operational transaction A system that avoids documenting deviations to reduce the number of possible findings

The QPPV should personally answer every operational question The QPPV should explain the overall system and demonstrate awareness of significant risks and weaknesses while operational experts address detailed processes The QPPV's role is limited to attending the opening and closing meetings The QPPV should delegate all inspection matters to the quality department

The number of pages in the associated SOP The seniority of the employee involved in the deviation The nature, extent, persistence and potential effect of the failure on patient safety and system reliability Whether the finding was identified during an announced inspection

Inspectors generally refuse to review individual cases A small set of good examples may not demonstrate that controls work consistently across the population Case examples cannot be used as evidence under EU procedures Excellent cases automatically indicate that the associated SOP is invalid