UNIT 11: Pharmacovigilance Systems, Quality Management, Audits, and Inspections
This unit explains how a compliant Pharmacovigilance system is structured, maintained, and continuously improved through quality management, audits, and regulatory inspections. It reflects real-world regulatory expectations for system oversight, documentation, and inspection readiness across global PV operations.
A Pharmacovigilance (PV) system is a structured framework established by a Marketing Authorization Holder to fulfill its pharmacovigilance obligations and ensure continuous monitoring of medicine safety. The PV system integrates people, processes, procedures, and tools to collect, evaluate, and report safety data in compliance with regulatory requirements.
Key Points
Ensures continuous safety monitoring.
Supports regulatory compliance.
Applies across the entire product lifecycle.
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