by Dr. Yashashwini Reddy | Sep 11, 2025
📌 Current Good Manufacturing Practices (cGMP) in Pharmaceutical Industries Definition:cGMP (Current Good Manufacturing Practices) are the regulations enforced by regulatory authorities (like US FDA, EMA, WHO, MHRA, CDSCO, etc.) to ensure that pharmaceutical products...
by Dr. Yashashwini Reddy | Sep 11, 2025
📌 Change Control in Pharmaceuticals Definition:Change Control is a systematic approach to managing all changes made to processes, equipment, systems, or documents in the pharmaceutical industry to ensure compliance with Good Manufacturing Practices (GMP), product...
by Dr. Yashashwini Reddy | Sep 11, 2025
📌 Deviation Control in Pharmaceuticals Definition:Deviation control in pharmaceuticals refers to the systematic process of identifying, documenting, investigating, and resolving any departure from approved processes, procedures, or specifications in a GMP-regulated...
by Dr. Yashashwini Reddy | Sep 10, 2025
📊 Annual Product Quality Review (APQR / APR / PQR) in Quality Improvements 🔎 What is APQR / APR / PQR? A systematic, documented review of all licensed products conducted annually (or periodically) as per ICH Q10, EU GMP, and FDA requirements. Objective: To verify the...
by Dr. Yashashwini Reddy | Sep 10, 2025
🏭 Guidelines for Preparation of Site Master File (SMF) 📑 1. General Information Company name, address, and contact details. Name of parent company (if applicable). Manufacturing activities performed at the site. Products handled (human, veterinary, APIs, biologicals,...
