by Dr. Yashashwini Reddy | Aug 18, 2025
Cleaning Validation Procedure for Clean-in-Place (CIP) Systems 1. Objective To establish a validated cleaning procedure for Clean-in-Place (CIP) systems ensuring removal of product residues, cleaning agents, and microbial contaminants to acceptable levels. 2. Scope...
by Dr. Yashashwini Reddy | Aug 9, 2025
Common Causes of Low Quality in Pharmaceuticals Ensuring high-quality pharmaceuticals is crucial to patient safety, regulatory compliance, and brand reputation. Low-quality products can lead to therapeutic failure, adverse reactions, and recalls. The following are...
by Dr. Yashashwini Reddy | Jun 25, 2025
✅ GVP Module XVI – Addendum II: Methods for Evaluating the Effectiveness of Risk Minimization Measures (RMMs) 📘 Purpose This addendum to GVP Module XVI provides specific methodologies and practical guidance for evaluating the effectiveness of risk minimization...
by Dr. Yashashwini Reddy | Jun 25, 2025
✅ GVP Module XVI – Risk Minimization Measures (RMMs) 📘 Purpose GVP Module XVI provides detailed guidance on the planning, implementation, evaluation, and effectiveness of risk minimization measures (RMMs) that are necessary to ensure safe use of medicinal products in...
by Dr. Yashashwini Reddy | Jun 25, 2025
✅ GVP Module XV – Safety Communication 📘 Purpose GVP Module XV provides guidance on how Marketing Authorization Holders (MAHs) and Regulatory Authorities should effectively communicate safety information about medicinal products to healthcare professionals, patients,...
