QPPV.COM KNOWLEDGE ASSESSMENT

Knowledge Assessment: GVP Module IV – Pharmacovigilance Audits

Test your understanding of the concepts covered by GVP Module IV: Pharmacovigilance Audits.

Question 1 of 10Pass mark: 80%

Question 1 of 10 What does CAPA effectiveness assessment primarily determine?

Whether the CAPA form was completed correctly Whether the process owner agrees that the action is complete Whether the implemented action reduced or prevented recurrence of the underlying problem Whether the finding can be removed from the final audit report

Question 2 of 10 A finding concerning inadequate medical-review documentation recurs after an SOP revision and retraining. What is the most appropriate interpretation?

The recurrence proves that additional identical training is the only solution The recurrence may indicate that the underlying cause, such as system support, ownership or process practicality, was not addressed The second finding should be ignored because the original CAPA was marked complete The issue should automatically be reclassified as a regulatory inspection finding

Question 3 of 10 What is the essential structure of a well-supported audit finding?

Personal opinion, recommended training and a proposed deadline Criterion, observed condition, supporting evidence and significance or risk A list of all documents reviewed without an assessment A description of the employee involved and an immediate disciplinary recommendation

Question 4 of 10 Which statement best describes appropriate QPPV involvement in the audit programme?

The QPPV must personally conduct every PV audit The QPPV needs meaningful visibility of significant findings, systemic risks, overdue CAPAs and the assurance provided by the programme The QPPV is involved only when a competent authority requests information The QPPV should review audit scheduling but not findings to preserve auditor independence

Question 5 of 10 Why is completion of 100% of scheduled audits not, by itself, evidence of an effective audit programme?

Because completed audits are never useful for assurance Because the schedule may have avoided high-risk areas or failed to adapt to changes in the risk profile Because only regulatory inspections can provide assurance Because audit programmes should not measure completion

Question 6 of 10 A finding states only that an employee failed to follow the SOP. What is the most appropriate next audit step?

Close the finding after retraining the employee Investigate whether unclear instructions, system design, workload, supervision or other factors caused the failure Classify the finding automatically as critical Remove the SOP from the quality system

Question 7 of 10 Which sampling approach is most appropriate for an audit of high-risk individual case safety report processing?

Select only the first cases listed in the database Select cases using characteristics relevant to the objective and risk, while documenting the population and limitations Select only cases that are easiest to retrieve Review a fixed number of cases without considering the population or audit objective

Question 8 of 10 Why should outsourced pharmacovigilance activities remain within the MAH's audit programme?

Because outsourcing transfers responsibility but not operational work Because outsourced activities remain part of the MAH's pharmacovigilance system and may affect regulatory and patient-safety obligations Because every vendor must be audited annually regardless of risk Because a vendor contract has no value unless accompanied by an audit

Question 9 of 10 Which CAPA package is most complete for repeated late safety reports?

A reminder email to staff with no further monitoring A revised SOP and immediate administrative closure Containment where needed, root-cause analysis, proportionate corrective and preventive actions, ownership, due dates and effectiveness assessment A decision to stop auditing the vendor

Question 10 of 10 Which issue is most likely to require system-level audit attention rather than only an individual process audit?

One typographical error in a single case narrative Unclear escalation, overlapping responsibilities and weak QPPV visibility across several PV processes A single completed training record One correctly completed reconciliation

Knowledge Assessment: GVP Module IV – Pharmacovigilance Audits

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