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 15, 2025
4 Tips to Reduce 483 Observations The FDA issues Form 483 to highlight potential GMP violations observed during inspections. Minimizing these observations requires a proactive approach to compliance and quality culture. 1. Strengthen Documentation Practices Ensure...
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 11, 2025
UV Cabinet Calibration in Pharmaceuticals 1. Introduction A UV Cabinet (also called a UV viewing cabinet or UV inspection chamber) is used in pharmaceutical laboratories for visual inspection of materials—especially for thin-layer chromatography (TLC) plates,...
by Dr. Yashashwini Reddy | Aug 10, 2025
Why Dissolution Test Apparatus Calibration with Salicylic Acid Tablets was Stopped Historically, salicylic acid tablets were used as calibration standards for dissolution test apparatus (mainly USP Apparatus 1 & 2) to check performance. However, this practice was...
