by Dr. Yashashwini Reddy | Sep 29, 2025
Aspect Audit Inspection Definition A systematic, independent review to assess compliance with internal or external standards (e.g., GMP). A formal review by a regulatory authority (e.g., FDA, EMA) to ensure compliance with laws and regulations. Conducted By Internal...
by Dr. Yashashwini Reddy | Sep 23, 2025
Case Study: Supply Chain Disruption – API Shortage Background A U.S.-based pharmaceutical company manufacturing essential cardiovascular and anti-diabetic medicines faced a sudden API (Active Pharmaceutical Ingredient) shortage in 2024. The primary API supplier was...
by Dr. Yashashwini Reddy | Sep 20, 2025
1. Premises and Equipment Use dedicated and clean facilities for production, storage, and filling of gases. Ensure gas cylinders, pipelines, valves, regulators, and manifolds are properly maintained and validated. Prevent cross-contamination between medical and...
by Dr. Yashashwini Reddy | Sep 18, 2025
📌 Types of Water in Pharmaceuticals, Usage, and Preparation Techniques 🔹 1. Potable Water (Drinking Water) Usage: Base feed for preparation of Purified Water, WFI, and Clean Steam. Used for general cleaning (non-product contact). Preparation Technique: Obtained from...
by Dr. Yashashwini Reddy | Sep 18, 2025
📌 Pharmaceutical AHU and HVAC Components In pharmaceuticals, HVAC (Heating, Ventilation, and Air Conditioning) systems are critical for maintaining controlled environments in cleanrooms, production areas, and laboratories to ensure GMP compliance, product quality, and...
