What is a QPPV Inspection?

It demonstrates that the implemented action solved the underlying problem and reduced the likelihood of recurrence It provides a substitute for root-cause analysis It is needed only for administrative findings and never for major findings It confirms merely that a CAPA record has been entered into a tracking system

Verify the scope and dates, log the notification, inform the QPPV and senior management, and establish an inspection response structure Rewrite all SOPs before confirming the inspection scope Send the regulator an unreviewed collection of all company documents Delay acknowledging the notification until every requested record has been located

The PSMF is not accurately reflecting the operating system and should be updated through controlled governance processes The discrepancy is acceptable because outsourced providers are outside the scope of the PSMF The discrepancy matters only if the former provider requests payment The PSMF should be updated only after the next regulatory inspection

To connect pharmacovigilance intelligence with organisational decisions, resources and escalation of significant risks To transfer all operational accountability from the MAH to the governance committee To ensure that only senior executives assess individual case causality To avoid documenting pharmacovigilance decisions in the PSMF

Repeated delayed expedited reports associated with a significant safety concern A routine annual update to an internal training presentation A planned replacement of office furniture in the pharmacovigilance department Completion of a scheduled management review with no identified issues

Prepare relevant personnel to explain actual processes clearly and support their answers with retrievable evidence Train staff to provide identical scripted answers regardless of how work is performed Restrict all interviews to the legal department Prevent operational staff from acknowledging process weaknesses

Acknowledge and assess the discrepancy, determine its impact and address the underlying process or documentation gap through controlled actions Instruct staff to describe the procedure exactly as written even if it is not followed Delete the procedure to eliminate the discrepancy from the inspection record Wait until inspection closure before documenting or investigating the issue

The selected CAPA should address the underlying cause of the problem, not merely correct the immediate symptom Root-cause analysis is unnecessary when the finding has already been classified as minor CAPA should always consist only of retraining the staff involved The root cause is determined after CAPA closure rather than before action selection

According to risk to patient safety and regulatory compliance, with high-risk actions receiving shorter timelines and stronger oversight According to which department has the largest budget By addressing the oldest finding first regardless of risk By assigning identical timelines to every finding

Current PSMF, controlled SOPs, trained staff, monitored KPIs, vendor oversight, CAPA effectiveness checks and periodic mock inspections A temporary inspection team created only after receiving a notification A single annual document clean-up without operational monitoring A complete set of policies with no evidence that they are implemented