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 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 | May 7, 2025
Standard Operating Procedure (SOP) 1. Objective To establish standardized procedures for reprocessing and reworking pharmaceutical products to ensure that all batches meet predefined specifications and maintain product quality. 2. Scope...
by Dr. Yashashwini Reddy | May 7, 2025
SOP for Failure Investigation in Pharmaceutical Manufacturing Here’s an overview of the Standard Operating Procedure (SOP) for Failure Investigation in pharmaceutical manufacturing, focusing on identifying root causes, implementing corrective and preventive...
by Dr. Yashashwini Reddy | Apr 20, 2025
Standard Operating Procedure (SOP) 1. Purpose: To define the procedure for managing and handling non-conforming products (NCP) in order to identify, segregate, and address quality issues, ensuring that only conforming products are released for use,...
