Pharmacovigilance System Master File (PSMF) Explained: Ultimate Guide to Compliance and Inspections Mastering the Pharmacovigilance System Master File (PSMF): Compliance-Ready Guide for Global Pharma Introduction to PSMF and Its Importance The Pharmacovigilance System Master File (PSMF) is a legally required document under the European Union’s Good Pharmacovigilance Practices (GVP), specifically outlined in GVP Module II. It provides regulators with a comprehensive description of the company’s pharmacovigilance (PV) system, including governance, processes, resources, and compliance metrics. The PSMF is designed to ensure that pharmaceutical companies maintain an auditable, inspection-ready framework for monitoring drug safety. By 2025, the PSMF has become a…