by Dr. Yashashwini Reddy | Sep 15, 2025
GMP Audit Checklist – Storage of Starting Materials 1. Storage Area Design & Conditions Is the storage area clean, well-lit, pest-free, and secure? Are temperature and humidity continuously monitored and recorded? Are conditions maintained as per material storage...
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 2, 2025
🔹 1. Process Optimization Lean Manufacturing (Lean Pharma): Eliminate non-value-added steps, reduce waiting times, optimize material flow. Six Sigma & QbD (Quality by Design): Use statistical tools (DoE, risk assessment) to identify Critical Process Parameters...
by Dr. Yashashwini Reddy | Aug 8, 2025
Investigation of OOS Results in Analytical Testing 1. What is an OOS Result? An Out-of-Specification (OOS) result is any analytical test result that falls outside the established acceptance criteria/specifications outlined in an approved method, regulatory filing, or...
