英语翻译制药用水是指用于制药工艺过程中的质量标准各不相同的水.本文介绍了制药用水的基本概念,水质要求,应用范围以及制药用水的检项,检项中着重阐述微生物限度检测.《药品生产管

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英语翻译
制药用水是指用于制药工艺过程中的质量标准各不相同的水.本文介绍了制药用水的基本概念,水质要求,应用范围以及制药用水的检项,检项中着重阐述微生物限度检测.《药品生产管理规范》（2010 年修订）第九十九条规定：纯化水、注射用水的制备、贮存和分配应当能够防止微生物的滋生.第一百条规定：应当对制药用水及原水的水质进行定期监测,并有相应记录.若发现制药用水微生物污染达到警戒限度、纠偏限度时应当按照操作过程处理.目的：通过高效合理的验证过程制定制药用水的微生物限度检验方法,使制药用水的微生物限度以及各检项满足新版GMP的要求.

Answer 1

Pharmaceutical water refers to the quality standard of pharmaceutical process in different water.制药用水是指用于制药工艺过程中的质量标准各不相同的水.
This paper introduces the basic concept, pharmaceutical water quality requirements, inspection items and the range of application of the pharmaceutical water, microbial limit testing focuses on testing items.本文介绍了制药用水的基本概念,水质要求,应用范围以及制药用水的检项,检项中着重阐述微生物限度检测.
"Good manufacturing practice" (2010 Revision) ninety-ninth provisions: purified water, water for injection preparation, storage and distribution should be able to prevent the breeding of microorganisms.《药品生产管理规范》（2010 年修订）第九十九条规定：纯化水、注射用水的制备、贮存和分配应当能够防止微生物的滋生.
Rule 100th: should quality on the pharmaceutical water and raw water are regularly monitored, and the corresponding record.第一百条规定：应当对制药用水及原水的水质进行定期监测,并有相应记录.
If it is found that the microbial contamination of water reached the warning limit, deviation limit shall be handled in accordance with the operation process.若发现制药用水微生物污染达到警戒限度、纠偏限度时应当按照操作过程处理.
Objective: microbial limit test method through the verification process efficient and reasonable formulation of pharmaceutical water, make the microbial limit pharmaceutical water and the inspection requirements to meet the new version of GMP.目的：通过高效合理的验证过程制定制药用水的微生物限度检验方法,使制药用水的微生物限度以及各检项满足新版GMP的要求.
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