QPPV.COM KNOWLEDGE ASSESSMENT

GVP Module II: Pharmacovigilance System Master File Knowledge Assessment

Test your understanding of the concepts covered by GVP Module II Explained: The Pharmacovigilance System Master File.

Question 1 of 10Pass mark: 80%

Question 1 of 10 Which sequence best represents the type of information flow the PSMF should help an informed reviewer understand?

Procurement, invoicing, budgeting, payment and archiving Safety-information sources, intake, processing, assessment, risk or signal activities, reporting and action Recruitment, onboarding, promotion, compensation and retirement Product manufacture, packaging, distribution, sales and returns only

Question 2 of 10 Which characteristic is essential for a PSMF annex maintained in a spreadsheet or another supporting system?

It may be stored informally if the document owner knows where it is It should have appropriate ownership, version control, accessibility and traceability It should be excluded from the PSMF change history It should contain all underlying operational records

Question 3 of 10 Which combination most accurately represents the core qualities on which the PSMF's regulatory and governance value depends?

Length, visual design, confidentiality and infrequent revision Accuracy, currency, accessibility and traceability Technical complexity, automation, centralisation and volume Legal formality, archival storage, delegation and brevity

Question 4 of 10 Which statement best reflects the QPPV's relationship with the PSMF?

The QPPV must personally edit every section The QPPV has no responsibility if document control is delegated The QPPV should have appropriate oversight and be able to understand significant changes to the system described The QPPV is responsible only for approving the document's formatting

Question 5 of 10 Which statement best describes the primary purpose of the PSMF?

To serve as the complete repository for all pharmacovigilance records To provide a current, structured description of the MAH's pharmacovigilance system and how it is controlled To replace the MAH's pharmacovigilance quality system To document only the QPPV's individual responsibilities

Question 6 of 10 Why may frequently changing product or organisational information be maintained in controlled annexes or linked authoritative systems?

To avoid controlling the information To keep dynamic information current while reducing unnecessary rewriting of the main narrative To make the information inaccessible to inspectors To replace the need for a main PSMF narrative

Question 7 of 10 Two legal entities use a shared safety database and common case-processing team. What should the PSMF governance model make clear?

That the shared database itself determines legal responsibility Which entity is responsible for each activity, how information is exchanged, how changes are controlled and how oversight is obtained That no entity needs individual accountability because the system is shared Only the database's technical specifications

Question 8 of 10 Which inspection-readiness exercise most effectively tests whether the PSMF functions as a reliable knowledge map?

Ask an employee to recite the entire PSMF from memory Select a major PSMF statement and ask an operational employee to identify the corresponding process, system and evidence Check only whether the PSMF has a signature page Compare the PSMF font and formatting with the corporate template

Question 9 of 10 An MAH transfers literature monitoring from an internal team to an external provider. What should happen first from a PSMF governance perspective?

Wait until the next scheduled annual review Assess the change for its impact on the PSMF and update the relevant description when required Insert the full vendor contract into the PSMF Delete all historical information about internal literature monitoring

Question 10 of 10 What is the most appropriate role of the PSMF regarding deviations and CAPA?

To contain every individual deviation and CAPA record To describe the framework for detecting, assessing, escalating and correcting significant compliance issues To approve all CAPA actions directly To eliminate the need for deviation management procedures

GVP Module II: Pharmacovigilance System Master File Knowledge Assessment

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