by Dr. Yashashwini Reddy | Aug 18, 2025
Quality System in Pharmaceuticals A Quality System in pharmaceuticals is the framework that ensures drugs are consistently developed, manufactured, tested, and distributed in compliance with Good Manufacturing Practices (GMP), regulatory requirements, and patient...
by Dr. Yashashwini Reddy | Aug 18, 2025
Contamination Control Strategies for Manufacturing Area In pharmaceutical manufacturing, contamination control is critical to ensure product quality, patient safety, and regulatory compliance. Contamination can occur in the form of particulate, microbial, chemical, or...
by Dr. Yashashwini Reddy | Jun 25, 2025
✅ GVP Module X – Additional Monitoring 📘 Purpose GVP Module X outlines the principles and procedures related to “Additional Monitoring” of certain medicines to enhance early identification of new safety information. It ensures transparency and helps promote reporting...
by Dr. Yashashwini Reddy | Jun 25, 2025
✅ GVP Module VIII – Post-Authorization Safety Studies (PASS) 📘 Purpose GVP Module VIII provides guidance on the design, conduct, and reporting of Post-Authorization Safety Studies (PASS) conducted by Marketing Authorization Holders (MAHs) after a product has been...
by Dr. Yashashwini Reddy | Jun 18, 2025
Here’s a complete view of pharmacovigilance—a structured, end‑to‑end journey that ensures drug safety from lab to real-world use: 1. Definition & Scope Pharmacovigilance (PV) is the science and set of processes for detecting, assessing, understanding, and...
