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 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
📦 Checklist for Audit in Warehouse (Pharmaceuticals) 1. General Warehouse Conditions ✅ Clean, well-organized, and free from dust, pests, and waste. ✅ Adequate space for material movement and segregation. ✅ Environmental monitoring records available (temperature,...
by Dr. Yashashwini Reddy | Sep 10, 2025
⚖️ Analytical Balance Drift 🔎 What is Drift? Drift refers to the gradual change in the displayed weight reading of an analytical balance over time without any actual change in the sample’s mass. It is typically observed when the balance reading keeps increasing or...
by Dr. Yashashwini Reddy | Sep 10, 2025
✅ 4 Tips to Reduce 483 Observations 1. Strengthen Documentation Practices Ensure records are contemporaneous, complete, and accurate (ALCOA+ principles). Use controlled logbooks, proper version control, and audit trails. Train staff to document activities at the time...
