QPPV.COM KNOWLEDGE ASSESSMENT

EU Pharmacovigilance Inspection Findings: CAPA Effectiveness and Recurrence of Deficiencies

Test your understanding of the concepts covered by EU Pharmacovigilance Inspection Findings: CAPA Effectiveness and Recurrence of Deficiencies.

Question 1 of 10Pass mark: 80%

Question 1 of 10 What does publication of a revised SOP primarily demonstrate?

Sustained effectiveness of the revised process. Implementation of a document change, but not necessarily that the instruction is followed or produces the intended outcome. Elimination of all possible root causes. Adequacy of the sampling strategy used for verification.

Question 2 of 10 What does a sample with no observed errors during effectiveness verification demonstrate?

That the process can no longer fail. That the sample provides evidence about performance under the sampled conditions, but not absolute proof of future performance. That the root cause was correctly identified. That the sample size was necessarily adequate.

Question 3 of 10 Which sequence best reflects a sound inspection-oriented CAPA reasoning chain?

Training, closure, correction, scope assessment, recurrence review. Finding, immediate correction, scope assessment, root cause, corrective action, implementation, effectiveness verification and recurrence monitoring. CAPA assignment, SOP revision, closure, root-cause analysis and audit. Metric selection, sampling, finding classification, correction and training.

Question 4 of 10 A CAPA addresses missed escalation triggers. Which effectiveness measure is most directly aligned with the intended control?

The percentage of staff who completed escalation training. The date on which the revised escalation SOP was approved. A review of subsequent cases to determine whether escalation occurred when defined triggers were met. The number of CAPAs closed by their due date.

Question 5 of 10 Which situation most strongly suggests that a recurrence may reflect an inadequate original effectiveness assessment?

The later event involves a completely different process and cause. The original assessment measured training completion but did not test whether the affected intake control operated correctly. The later event was detected through routine monitoring. The original CAPA was implemented before the recurrence occurred.

Question 6 of 10 A central case-processing workflow is found to contain a control failure. Which scope assessment is most appropriate?

Review only the case sampled by the inspector. Review only cases processed by the individual involved. Consider all products and activities using the workflow, as well as relevant periods, affiliates, systems and personnel. Assume the issue is systemic across the entire company without further analysis.

Question 7 of 10 Different deficiencies occur in case quality control, aggregate-report review and vendor oversight. What is the most appropriate interpretation?

They automatically constitute one systemic finding. They are unrelated because the operational processes differ. They may indicate a shared weakness such as ownership, escalation or quality review and warrant pattern analysis. They should be combined into one CAPA without investigating individual causes.

Question 8 of 10 For a vendor-related pharmacovigilance deficiency, what must the MAH ultimately demonstrate?

Only that the vendor completed its local CAPA. Only that the contract contains a quality clause. That the overall outsourced pharmacovigilance control is effective, supported by appropriate oversight and performance evidence. That responsibility for the issue has been transferred to the vendor.

Question 9 of 10 Which responsibility best describes appropriate QPPV oversight of significant CAPA?

The QPPV should personally perform every CAPA action. The QPPV should have appropriate visibility of significant deficiencies, risk, remediation and effectiveness without replacing the quality function or CAPA owner. The QPPV should approve every routine procedural change. The QPPV should take ownership whenever a CAPA becomes overdue.

Question 10 of 10 Several months after a CAPA is closed, a similar late-processing error occurs. What should the organisation do first?

Automatically declare the original CAPA unreasonable. Ignore the event because the CAPA was already closed. Determine whether the event is the same, related or unrelated failure mode and reassess the original control if appropriate. Change the effectiveness criterion so that the prior CAPA remains effective.

EU Pharmacovigilance Inspection Findings: CAPA Effectiveness and Recurrence of Deficiencies

Cookie Settings