QPPV.COM KNOWLEDGE ASSESSMENT

Inspection Readiness in Pharmacovigilance

Test your understanding of the concepts covered by Inspection Readiness in Pharmacovigilance.

Question 1 of 10Pass mark: 80%

Question 1 of 10 A retrieval SLA for core PSMF sections is defined, but the organisation has never tested it. What is the main control gap?

The SLA is automatically invalid because all evidence must be available immediately The organisation lacks evidence that the stated retrieval capability works in practice The PSMF cannot contain retrieval targets Only IT can validate retrieval performance

Question 2 of 10 What is the principal purpose of a RACI or equivalent responsibility matrix in inspection readiness?

To demonstrate that all employees have completed the same PV training To define accountability, authority and interfaces for critical pharmacovigilance activities To rank vendors according to their commercial importance To replace quality agreements and safety data exchange agreements

Question 3 of 10 What is the best approach when the primary owner of critical inspection evidence is unavailable during an inspection?

Wait until the owner returns before supplying the evidence Ask the inspector to accept a verbal summary instead Use predefined deputies and escalation contacts documented in continuity arrangements Create a replacement document during the inspection

Question 4 of 10 During an inspection, an SME gives an answer that conflicts with the current PSMF and available records. What does this most likely indicate?

The conflict is immaterial because interviews are informal The organisation may have a training, process-understanding or documentation-control weakness requiring investigation The PSMF should immediately be changed to match the interview answer The SME should provide a more detailed answer without consulting evidence

Question 5 of 10 Which CAPA record would provide the strongest evidence of effective remediation?

A closed CAPA with a broad action such as 'retrain staff' A CAPA with an owner and due date but no root-cause analysis A CAPA with root cause, measurable actions, completion evidence and outcome-based effectiveness checks A CAPA marked complete once the finding has been discussed in a meeting

Question 6 of 10 A PSMF states that vendor performance is reviewed quarterly, but no review records or performance metrics can be produced. What would an inspector most likely question?

Whether the PSMF is too concise Whether the described control is implemented in practice Whether the vendor contract should be stored in the PSMF itself Whether quarterly reviews are legally prohibited

Question 7 of 10 An organisation has comprehensive SOPs, but its meeting minutes, training records and case-processing metrics are not readily retrievable. What is the most appropriate conclusion?

The organisation is inspection-ready because SOPs are the primary inspection evidence The organisation is ready provided the QPPV can describe the processes verbally Readiness is incomplete because inspectors assess living evidence as well as controlled documents The issue affects only administrative efficiency and is unlikely to affect inspection risk

Question 8 of 10 Why are quarterly retrieval drills valuable even when an organisation has a well-controlled document management system?

They eliminate the need for document version control They verify that assigned owners can produce current evidence within agreed timelines under realistic conditions They prove that every document is legally confidential They replace internal audits of the pharmacovigilance system

Question 9 of 10 A company adds a high-risk safety vendor but does not assess the change or update relevant PSMF sections. Which control weakness is most directly demonstrated?

Insufficient aggregate-reporting methodology Failure of change control and system-documentation linkage Inadequate redaction of individual case safety reports Insufficient interview briefing for subject-matter experts

Question 10 of 10 What is the most important inspection-readiness function of the PSMF?

To replace the organisation's SOPs and detailed operational records To provide an accurate, consolidated description of the pharmacovigilance system linked to supporting evidence To document only the QPPV's qualifications and contact details To serve as an archive for every individual safety case

Inspection Readiness in Pharmacovigilance

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