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...
