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 Why should an audit scope explicitly state what is outside the audit?

To allow the auditor to avoid documenting limitations To make the conclusions clearer by defining the boundaries of the assessment To ensure that the audit can be classified as minor To prevent process owners from reviewing the report

Question 2 of 10 What is the most appropriate use of an audit universe?

To list only areas that have previously generated inspection findings To provide a structured representation of important PV components for risk assessment and programme planning To establish that every listed process must be audited annually To replace the need for documented audit-scheduling rationale

Question 3 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 4 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 5 of 10 Which factor is most important when assessing auditor independence?

Whether the auditor is employed by an external consultancy Whether the auditor can evaluate the area objectively and report findings without inappropriate influence Whether the auditor has previously worked in the audited process Whether the audit report contains no adverse findings

Question 6 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 7 of 10 A vendor has met its contractual processing KPI, but reconciliation discrepancies between the vendor and MAH databases are not investigated. What is the best audit interpretation?

The vendor is adequately controlled because the KPI was met The KPI should be accepted as conclusive evidence of compliance The audit should test the underlying reconciliation control because aggregate performance metrics may conceal important weaknesses The discrepancy is irrelevant if no delayed reports were identified

Question 8 of 10 How should interviews generally be used as audit evidence?

Interview statements alone are sufficient to prove implementation Interviews should be compared with procedures, records and system evidence Interviews should never be used because they are subjective The most senior interviewee's statement should override documented evidence

Question 9 of 10 Which evidence best demonstrates competence in addition to completion of assigned training?

A training matrix showing that the course was assigned A signed attendance sheet only Role-specific qualification, competency assessment and acceptable quality or performance results A procedure stating that staff are expected to be competent

Question 10 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

QPPV.com

Knowledge Assessment: GVP Module IV – Pharmacovigilance Audits

Cookie Settings