PV002: SOP FOR PHARMACOVIGILANCE MASTER FILE (PSMF) PREPARATION & MAINTENANCE
OBJECTIVE: To define the procedure for preparation, approval, maintenance, and control of the Pharmacovigilance Master File (PSMF) in accordance with World Health Organization (WHO) guidelines, European Union Good Pharmacovigilance Practices (EU-GVP) Module II, and applicable national PV regulations. SCOPE: This SOP applies to all activities related to creating, updating, managing, and maintaining the PSMF for […]