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 Which situation most strongly suggests that governance is administrative rather than effective?

A safety committee reviews trends and assigns tracked actions Management reviews KPIs and escalates recurring compliance problems Meeting attendance is recorded, but there are no substantive minutes, decisions or follow-up evidence The QPPV documents review of a significant safety issue

Question 2 of 10 An organisation's ICSR timeliness dashboard shows good overall performance, but sample cases contain inconsistent triage and narrative practices. What is the most appropriate interpretation?

The dashboard proves the ICSR process is fully effective The sample cases are irrelevant if aggregate timeliness is acceptable Readiness may be weak because performance metrics should be corroborated by case-level evidence of process adherence The issue can be resolved by removing the affected cases from the sample

Question 3 of 10 Why should interview preparation focus on process flows, escalation and evidence sources rather than memorising SOP wording?

Inspectors generally do not review SOPs Memorisation prevents interviewees from discussing compliance issues Inspectors test whether staff understand and perform the process in practice, including how evidence is generated SOP wording is legally invalid during an inspection

Question 4 of 10 Which scenario best demonstrates consistency between the PSMF and organisational reality?

The PSMF lists an obsolete vendor because the vendor contract remains archived The PSMF describes current responsibilities, vendors and SOP interfaces that match approved records and operational evidence The PSMF contains generic descriptions so that changes do not require updates The PSMF excludes outsourced activities because they are performed outside the MAH

Question 5 of 10 Which feature most improves the practical retrievability of PSMF supporting evidence?

Maintaining evidence in separate locations without cross-references to preserve flexibility Using a central evidence register that maps PSMF sections to files, owners, locations and verification dates Printing all records and storing them in the inspection lead's office Including only document titles in the PSMF without storage paths or responsible roles

Question 6 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 7 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 8 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 9 of 10 Which evidence best supports management's claim that pharmacovigilance risks are actively monitored?

A policy statement declaring that risk management is important A dashboard showing trends, management review records, documented decisions and follow-up actions An old risk assessment with no review date A list of regulatory references in the PSMF

Question 10 of 10 How should an audit programme generally determine coverage and frequency for vendors and PV activities?

Use the same audit frequency for every vendor to ensure consistency Audit only when an inspection is announced Apply a risk-based approach that prioritises critical vendors and higher-risk activities Audit only vendors with the largest contract values

Inspection Readiness in Pharmacovigilance

Cookie Settings