by Dr. Yashashwini Reddy | Oct 9, 2025
Analytical procedure development is the process of designing and optimizing methods to accurately and precisely measure the active pharmaceutical ingredient (API), excipients, impurities, and degradation products in a drug substance or drug product. The goal is to...
by Dr. Yashashwini Reddy | Sep 23, 2025
📝 Case Study: OOS Investigation – Tablet Dissolution 📍 Background A marketed immediate-release tablet showed dissolution failure during routine quality control testing. Specification: NLT (Not Less Than) 80% drug release in 30 minutes. Observed result: 60–65% release...
by Dr. Yashashwini Reddy | Sep 18, 2025
📌 Importance of Differential Pressure in Pharmaceuticals Prevents Cross-Contamination Differential pressure ensures controlled airflow between cleanrooms of different classifications. Positive pressure in cleaner areas prevents entry of dust, microbes, and...
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...
