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 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 2 of 10 Which approach best reflects the distinction between the PSMF and SOPs?

The PSMF should reproduce every step of every pharmacovigilance procedure SOPs are unnecessary if the PSMF describes the system clearly The PSMF should explain the system architecture and refer to controlled procedures for operational detail The PSMF should contain only SOP titles without explaining their relevance

Question 3 of 10 Which statement best captures the appropriate treatment of the quality system in the PSMF?

The PSMF should reproduce every quality record and CAPA file The PSMF should describe the relevant quality-management arrangements and controls without duplicating the entire quality system The PSMF should omit quality arrangements because they are outside pharmacovigilance The PSMF should replace the audit programme

Question 4 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 5 of 10 Which information is most appropriate for the PSMF when an important activity is outsourced?

Every invoice issued by the service provider The vendor's complete internal quality manual The nature of the outsourced activity, its role in the system, oversight arrangements and key interfaces Only the vendor's corporate legal name

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 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 8 of 10 Why is the PSMF considered to have a governance function in addition to a descriptive function?

Because it authorises all pharmacovigilance procedures Because preparing and maintaining it requires the organisation to understand and control how its system actually operates Because it gives the QPPV authority over every business function Because it contains the legally binding terms of vendor contracts

Question 9 of 10 Why are interfaces with functions such as Regulatory Affairs, Quality Assurance and Information Technology important in the PSMF?

Because those functions automatically become part of the QPPV's department Because safety information, responsibilities and controls often cross organisational boundaries Because the PSMF must include all corporate procedures Because interface descriptions remove the need for written agreements

Question 10 of 10 Which example is performance information rather than merely activity data?

The number of cases received The number of training sessions scheduled The percentage of cases processed within the required timeframe The number of vendor meetings held

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GVP Module II: Pharmacovigilance System Master File Knowledge Assessment

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