Core Viewpoint - The article discusses the draft guidelines for the inspection of pharmaceutical water, emphasizing the importance of water quality in the pharmaceutical production process and its direct impact on drug quality and patient safety [3][5]. Summary by Sections Overview - Pharmaceutical water refers to various quality-standard waters used in the pharmaceutical production process, and its preparation and distribution systems are critical to drug quality, making it a high-risk public utility system [12][13]. Purpose - The guidelines aim to ensure drug quality and patient safety by providing a framework for quality risk management in the preparation of drinking water, purified water, injection water, and pure steam [14]. Scope - The guidelines serve as a technical reference for on-site inspections of drinking water, purified water, injection water, and pure steam systems used in pharmaceutical production [15]. Pharmaceutical Water Risk Management - Quality risk management should consider facility design, execution of well-designed procedures, and continuous compliance with expected results [16][17]. - Companies must minimize contamination risks and ensure water quality meets national standards and regulatory requirements [17]. - Risk management should encompass the entire process of pharmaceutical water, including design, preparation, usage, and monitoring [17]. Drinking Water Inspection Points - Drinking water should be sourced primarily from municipal supplies, with regular quality assessments and monitoring to ensure compliance with national standards [19]. Purified Water Inspection Points - The purified water system typically consists of a pre-treatment system and a purification system, with regular cleaning and monitoring required to meet quality standards [21][22]. - Key inspection points include system confirmation and validation, installation confirmation, operational confirmation, and performance confirmation [22][23][24]. Injection Water Inspection Points - Injection water is critical for the quality of sterile drugs, with distillation being the preferred method for its preparation [45]. - Non-distillation methods such as membrane separation and deionization can also be used, provided they meet equivalent quality standards [46].