[生物学]水生物负荷以及微生物限度检查.pdf

Water for pharmaceutical purpose Microbial limit tests Harmonization of EP, USP and JP – Impact and Changes 制药用水检测制药用水检测，协合药典微生物限度检测的影响与改变，协合药典微生物限度检测的影响与改变 制药用水检测制药用水检测，，协合药典微生物限度检测的影响与改变协合药典微生物限度检测的影响与改变 Jan Fricke Water for pharmaceutical purpose Chapter1231 Water is widely used as a raw material, ingredient, and solvent in the processing, formulation, and manufacture of pharmaceutical products, active pharmaceutical ingredients (APIs) and intermediates, compendial articles, and analytical reagents. 水以原料成分或溶剂被广泛地应用在加工，配制，生产药品，原料，中间 体和分析试剂中。 This general information chapter provides additional information about water, its quality attributes that are not included within a water monograph, processing techniques that can be used to improve water quality, and a description of minimum water quality standards that should be considered when selecting a water source.此通则提供了在水 专论中没有包括的信息水的质量。可以使用加工技术改善水质，选择水源 是应考虑最低水质标准。 Water for pharmaceutical purpose SOURCE OR FEED WATER CONSIDERATIONS 源水或进水 To ensure adherence to certain minimal chemical and microbiological quality standards, water used in the production of drug substances or as source or feed water for the preparation of the various types of purified waters must meet the requirements of the National Primary Drinking Water Regulations (NPDWR) (40 CFR 141) issued by the U.S. Environmental Protection Agency (EPA) or the drinking water regulations of the European Union or Japan, or the WHO drinking water guidelines. 为了保证符合特定最小含量的化学和微生物质量。水作为生产中的物 质或源水或处理为各种纯水的进水，必须符合饮用水标准。 Monitoring of Drinking Water Directive 98/83/EC on the quality of water intended for human consumption, Appendix 1 Part A 1 General requirements intended for water for human consumption 人类饮用水一般要求 Lfd. No.: Parameter Values