USPS [1231]制药用水 翻译.docVIP

?1231?WATER FOR PHARMACEUTICAL PURPOSES 制药用水 Water is the most widely used substance,raw material,or ingredient in the production,processing,and formulation of compendial articles.Control of the microbiological quality of these waters is important because proliferation of microorganisms ubiquitous to water may occur during the purification,storage,and distribution of this substance.If water is used in the final product,these microorganisms or their metabolic products may eventually cause adverse consequences. 在生产、加工和药典的配方中水是使用最广泛的物质、原辅料或成分。在物质净化、储存、配送的过程当中，水中微生物普遍生长的现象可能会出现，所以控制水的微生物质量就显得非常重要。如果在成品中用到水，这些微生物或它们代谢产物可能会引起负面的影响。 Water that is used in the early stages of the production of drug substances and that is the 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)(40CFR141)issued by the Environmental Protection Agency (EPA).Comparable regulations for drinking water of the European Union or Japan are acceptable. These requirements ensure the absence of coliforms , which, if determined to be of fecal origin, may portend or indicate the presence of other microorganisms of fecal origin, including viruses that may be pathogenic for humans. On the other hand, meeting these National Primary Drinking Water Regulations would not rule out the presence of other microorganisms,which,while not considered a major public health concern,could,if present,constitute a hazard or be considered undesirable in a drug substance or formulated product.For this reason,there are many different grades of pharmaceutical waters. 在药品原料生产的早期阶段，用水和不同类型净化用水准备中所用到的源水或给水，这些都必须满足环境保护机构（EPA）颁布的全国最初饮用水法规（NPDWR）（40CFR141）的要求。欧盟或日本其相当的饮用水标准也是可以采用。这些要求中规定不能有大肠菌的存在，如果它们被确定源自排泄物，那么就预示或显示着其它来源于排泄物的其它微生物存在，这当中包括引起人体致病的病毒。在另外一方面，那些符合全国最初饮用水法规要求的水中没有排除其它微生物存在的可能，未考虑及大众健康，如果存在，在药品产品和产品中就包括有害物质或不合需要的成分。基于这个原因，这有不同级别的制药用水。 TYPES OF WATER 不同类型的水 Drinking Water— Drinking Water is not covered by a