This SOP defines how pharmacovigilance activities are conducted, documented, and reported to ensure patient safety and regulatory compliance.
It outlines the process for collecting, evaluating, and reporting adverse events in accordance with GxP and EMA/FDA requirements.
The SOP is professionally written, pre-filled (≈ 99 % complete), and ready for implementation within your existing QMS framework.
Includes:
•Adverse event collection and processing
•Roles and responsibilities for PV oversight
•Reporting timelines to competent authorities
•Case documentation and database maintenance
•Audit, CAPA, and training references
This document provides a compliant structure for pharmacovigilance operations, ensuring traceability and readiness for authority inspections.