by Dr. Yashashwini Reddy | Sep 19, 2025
Water for Pharmaceutical Manufacturing and Testing Introduction Water is one of the most widely used raw materials in the pharmaceutical industry. It is used as a solvent, cleaning agent, processing aid, and testing reagent. Because of its critical role, water must...
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
1. Objective Demonstrate that the proposed purified water generation and distribution system is designed, specified and documented such that, when built and operated as designed, it will consistently produce Purified Water that meets USP requirements and is suitable...
by Dr. Yashashwini Reddy | Sep 15, 2025
Guide to Inspections of High Purity Water Systems 1. Introduction High Purity Water (HPW) systems, including Purified Water (PW), Water for Injection (WFI), and Highly Purified Water (HPW), are critical utilities in pharmaceutical manufacturing. Regulatory agencies...
by Dr. Yashashwini Reddy | Sep 13, 2025
1. System Design & Validation Water system (Purified Water, WFI, Potable Water) designed to meet pharmacopeial requirements (USP/EP/IP/JP). System qualification performed (DQ, IQ, OQ, PQ) with proper documentation. Risk assessment performed for potential...
