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
🏭 Preparation for GMP Audit in Pharmaceuticals 1. Understand the Audit Scope Know whether it’s regulatory (FDA, EMA, MHRA, WHO, CDSCO), customer, or internal. Review previous audit/inspection reports and ensure CAPAs are implemented. Be aware of current guidelines,...
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...
by Dr. Yashashwini Reddy | Sep 10, 2025
🔎 Major Audit Findings – Equipment & Instruments 1. Qualification & Validation Issues Missing or incomplete DQ/IQ/OQ/PQ records. Equipment used without initial or periodic requalification. Validation protocols not followed or not approved before execution....
