QPPV.COM KNOWLEDGE ASSESSMENT

PSMF and Pharmacovigilance System Governance Findings: EU Inspection Knowledge Assessment

Test your understanding of the concepts covered by PSMF and Pharmacovigilance System Governance Findings: What EU Inspectors Test.

Question 1 of 10Pass mark: 80%

Question 1 of 10 Which CAPA is most likely to address both correction and prevention after a material PSMF discrepancy?

Correct the PSMF only and file the revised version Correct the PSMF, assess affected sections and historical scope, strengthen change-control ownership, revise relevant processes, and verify effectiveness Provide informal reminders to document authors without changing any controls Wait for the next inspection to determine whether the issue recurs

Question 2 of 10 What is the best first response when an inspector identifies a discrepancy between the PSMF and current operations?

Immediately revise the affected paragraph and close the issue Establish the scope, timing, affected products and responsibilities, and assess the underlying control failure before determining the response Argue that the PSMF is only descriptive and therefore cannot be relevant Suspend all pharmacovigilance activities until the PSMF is reissued

Question 3 of 10 An affiliate's PSMF-described responsibility for local literature monitoring is being tested. Which traceability path is most appropriate?

PSMF statement to local procedure, responsible person, training record and operational evidence PSMF statement to product sales data and corporate communications PSMF statement to the affiliate's marketing authorisation application only PSMF statement to the QPPV's personal calendar

Question 4 of 10 Which document-control approach best supports continuous, evidence-backed PSMF maintenance?

Update the PSMF only when an inspector requests it Link relevant system changes to an impact assessment, controlled PSMF update or documented no-update conclusion, and appropriate review Allow each affiliate to edit the PSMF directly whenever it changes a local process Conduct periodic proofreading without reviewing operational changes

Question 5 of 10 Which approach best demonstrates effective QPPV oversight of PSMF accuracy?

The QPPV personally edits every section of the PSMF The QPPV signs the PSMF once and takes no further action The QPPV receives relevant information about changes and deficiencies and can influence decisions and escalation The QPPV delegates all oversight permanently to the document administrator

Question 6 of 10 Which statement most accurately reflects the role of technology changes in PSMF inspection readiness?

Technology changes are outside PSMF governance because the PSMF is not a validation document The PSMF should include every technical specification and validation test script Technology changes should be assessed for their effect on the pharmacovigilance system, with supporting technical evidence available where relevant Only changes to the product label can affect the PSMF

Question 7 of 10 Which statement about PSMF location and availability is most accurate?

A registered address is sufficient even if the organisation cannot retrieve the authoritative file promptly The PSMF should have the required EU location and must be available for inspection, including provision to competent authorities within the required timeframe The PSMF may be maintained only in the global headquarters outside the EU Availability means that a summary can be provided instead of the authoritative PSMF

Question 8 of 10 A major safety database migration occurs shortly after the annual PSMF review. What is the most appropriate control response?

Wait until the next annual review because the document was recently approved Assess the migration's effect on the pharmacovigilance system and determine through change control whether the PSMF requires updating Update the PSMF automatically without assessing the operational impact Delete technical system information from the PSMF to avoid future discrepancies

Question 9 of 10 Which statement best distinguishes completeness from accuracy in a PSMF?

A PSMF is accurate whenever it contains all expected headings Completeness concerns the presence of expected content, whereas accuracy concerns whether that content reflects the current system Accuracy is relevant only to product lists, while completeness applies only to procedures A complete PSMF cannot be inaccurate

Question 10 of 10 Which effectiveness measure is best aligned with a finding caused by missing PSMF change-control triggers?

Confirm that the revised PSMF has been signed Confirm that employees completed a general PSMF training module Sample material system changes over a defined period and verify that PSMF impact was consistently assessed Count the number of pages in the revised PSMF

PSMF and Pharmacovigilance System Governance Findings: EU Inspection Knowledge Assessment

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