QPPV.COM KNOWLEDGE ASSESSMENT

GVP Module I: Pharmacovigilance Systems and Quality Systems Knowledge Assessment

Test your understanding of the concepts covered by GVP Module I Explained: Pharmacovigilance Systems and Quality Systems.

Question 1 of 10Pass mark: 80%

Question 1 of 10 An MAH has current SOPs, a complete PSMF and extensive training records, but recurring reconciliations are late and unresolved discrepancies are common. What is the most appropriate conclusion?

The system is compliant because its documentation is complete The problem is limited to document control The documented system may not be operating effectively in practice The issue is irrelevant if no inspection has identified it

Question 2 of 10 Repeated similar processing errors are observed across several employees. What should the investigation consider first?

Whether the employees should all receive the same generic training module Whether the pattern indicates unclear procedures, workload, system design or ineffective controls Whether the errors can be excluded because each event involved a different person Whether the SOP should be archived to avoid further confusion

Question 3 of 10 What is the most appropriate way to maintain the PSMF in a mature pharmacovigilance system?

Treat it as a static annual document independent of operational changes Update it only after an inspection finding Maintain it as a current, structured description that reflects actual organisational, vendor, system and process arrangements Use it as a replacement for procedures and operational records

Question 4 of 10 An MAH outsources case processing to a vendor. Which statement best reflects the MAH's responsibility?

The vendor assumes all regulatory responsibility once the contract is signed The MAH remains responsible for ensuring that outsourced activities are appropriately controlled and overseen The QPPV is responsible only if the vendor is located outside the EU Oversight is unnecessary if the vendor has a pharmacovigilance certificate

Question 5 of 10 How should proportionality generally be applied when designing a pharmacovigilance quality system?

By omitting activities that are difficult for a small organisation to perform By applying the same level of complexity to every MAH By adapting implementation and controls to organisational and product risks while still meeting applicable requirements By allowing outsourced providers to determine which legal obligations apply

Question 6 of 10 A vendor KPI reports 98% on-time performance, but serious cases are sometimes submitted late. What is the best Module I assessment?

The vendor is acceptable because the aggregate KPI exceeds its target The KPI should be examined for whether it masks risk-relevant failures and whether escalation is risk-based The late serious cases can be ignored if they are corrected later The issue should be addressed only by assigning additional training

Question 7 of 10 What is the most appropriate interpretation of the QPPV's oversight role?

The QPPV must personally perform or review every operational pharmacovigilance task The QPPV should have reliable mechanisms and information to identify material compliance and safety risks The QPPV's role is limited to approving SOPs The QPPV may rely solely on annual confirmation from department heads

Question 8 of 10 Which responsibility model best supports continuity when personnel change?

Assigning tasks informally to whichever individual is available Assigning accountability to named individuals without defining their roles Defining role-based accountability, execution, review, escalation and oversight responsibilities Allowing each department to interpret shared responsibilities independently

Question 9 of 10 Which evidence most directly supports the conclusion that personnel are competent for a complex pharmacovigilance activity?

A record showing that an electronic training module was assigned A record showing that the employee completed a general induction course Documented observation or assessment demonstrating correct performance of the activity A job title indicating that the employee works in pharmacovigilance

Question 10 of 10 Which statement best distinguishes quality control from quality assurance?

Quality control concerns individual processes or outputs, whereas quality assurance provides broader confidence that the system is established and effective Quality control is performed only by auditors, whereas quality assurance is performed only by operations Quality control concerns training, whereas quality assurance concerns case processing There is no meaningful distinction between the two concepts

GVP Module I: Pharmacovigilance Systems and Quality Systems Knowledge Assessment

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