by Dr. Yashashwini Reddy | Aug 8, 2025
Here’s a clear breakdown of the Steps for Analytical Method Development in pharmaceuticals, following regulatory expectations like ICH Q2(R2): Steps for Analytical Method Development Define the Objective (Method Purpose) Understand what needs to be measured (API,...
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 26, 2025
Here is a comprehensive list and explanation of ICH Guidelines related to Pharmacovigilance, which aim to harmonize safety monitoring practices across regulatory regions: ✅ Core ICH Guidelines for Pharmacovigilance Code Title Focus Area E2A Clinical Safety Data...
by Dr. Yashashwini Reddy | Jun 25, 2025
✅ GVP Module VII – Periodic Safety Update Report (PSUR) 📘 Purpose GVP Module VII provides guidance on the preparation, submission, and assessment of Periodic Safety Update Reports (PSURs) by Marketing Authorization Holders (MAHs).It ensures the continuous benefit-risk...
by Dr. Yashashwini Reddy | Apr 19, 2025
1. What are stability studies and why are they important? Stability studies determine how the quality of a drug substance or product varies over time under the influence of environmental factors (e.g., temperature, humidity, light). They are essential for setting...
