by Dr. Yashashwini Reddy | Jun 26, 2025
📘 Pharmacovigilance System Master File (PSMF) ✅ What is PSMF? The Pharmacovigilance System Master File (PSMF) is a legal, detailed, and continuously maintained document that describes the pharmacovigilance (PV) system used by a Marketing Authorization Holder...
by Dr. Yashashwini Reddy | Jun 26, 2025
✅ Pharmacovigilance Audits and Inspections 🔍 1. Pharmacovigilance Audits 📘 Definition: A systematic, independent, and documented process to evaluate the pharmacovigilance (PV) system, its quality system, and compliance with regulatory requirements. 📌...
by Dr. Yashashwini Reddy | Jun 24, 2025
GVP Module IV – Pharmacovigilance Audits 🔹 Purpose GVP Module IV provides guidance on the planning, conduct, reporting, and follow-up of audits of pharmacovigilance (PV) systems, including the role of quality assurance in maintaining PV compliance. 🔹 Key...
by Dr. Yashashwini Reddy | Jun 24, 2025
🕵️♀️ GVP Module III – Pharmacovigilance Inspections 🔹 Purpose GVP Module III provides guidance on how pharmacovigilance (PV) inspections are conducted by regulatory authorities in the EU to ensure compliance with PV obligations and to safeguard public health. 🔹 Key...
by Dr. Yashashwini Reddy | Jun 24, 2025
🗂️ GVP Module II: Pharmacovigilance System Master File (PSMF) 🔹 Purpose GVP Module II provides guidance on the structure, content, maintenance, and location of the Pharmacovigilance System Master File (PSMF), a key document required for all Marketing Authorization...
