justification of specification
This section provides justifications for analytical methods and specification limits used for the characterrization and routine qualify control of 产品名称.Items stated in the product specification are listed below:
justification of specification 质量标准起草说明？
specification limits 指标限度？
product specification 我觉得这里不应该翻译为产品说明书或产品规格，而应该是产品质量标准，结合上下文。
请大侠多多指教！
justification of specification
This section provides justifications for analytical methods and specification limits used for the characterrization and routine qualify control of 产品名称.Items stated in the product specification are listed below:
justification of specification 质量标准起草说明？
specification limits 指标限度？
product specification 我觉得这里不应该翻译为产品说明书或产品规格，而应该是产品质量标准，结合上下文。
请大侠多多指教！
2楼，您的翻译和我第一次翻译的相同。只是第一 个词在园子里有翻译为“质量标准起草说明”，有点拿不准选择哪一个。“质量标准的合理性说明”接近于直译，“质量标准起草说明”比较符合国内的说法。
justification of specification ：质量标准规范化说明
justification：a good and acceptable reason for doing something
justification of specification :翻译为规范的论证，也就是质量标准的合理性说明
specification limits :质量标准的限度，也就是各项的限度
product specification ：翻译为产品规范，也就是我们说的产品质量标准
可以参照下列ICH的原稿和中文译稿理解：
Specification:
A list of tests, references to analytical procedures, and appropriate acceptance criteria which are numerical limits, ranges, or other criteria for the tests described. It establishes the set of criteria to which a drug substance or drug product should conform to be considered acceptable for its intended use. "Conformance to specifications" means that the drug substance and / or drug product, when tested according to the listed analytical procedures, will meet the listed acceptance criteria. Specifications are critical quality standards that are proposed and justified by the manufacturer and approved by regulatory authorities.
规范 规范由一系列的试验、有关分析方法和认可标准组成，这些标准以限度值、范围或其他描述来表示。它建立了一套新原料药和制剂都必须遵循的、与其用途相适应的标准。
“符合规范”是指原料药和制剂按照给定的方法试验，符合认可标准。规范是重要的质量标准，它由生产商提出和验证、管理机构批准，并作为批准产品的依据。
楼上各位！
This section provides justifications for analytical methods and specification limits used for the characterrization and routine qualify control of 产品名称.Items stated in the product specification are listed below:
justification of specification 质量标准起草说明？
specification limits 指标限度？
product specification 我觉得这里不应该翻译为产品说明书或产品规格，而应该是产品质量标准，结合上下文。
请大侠多多指教！
justification of specification
This section provides justifications for analytical methods and specification limits used for the characterrization and routine qualify control of 产品名称.Items stated in the product specification are listed below:
justification of specification 质量标准起草说明？
specification limits 指标限度？
product specification 我觉得这里不应该翻译为产品说明书或产品规格，而应该是产品质量标准，结合上下文。
请大侠多多指教！
2楼，您的翻译和我第一次翻译的相同。只是第一 个词在园子里有翻译为“质量标准起草说明”，有点拿不准选择哪一个。“质量标准的合理性说明”接近于直译，“质量标准起草说明”比较符合国内的说法。
justification of specification ：质量标准规范化说明
justification：a good and acceptable reason for doing something
justification of specification :翻译为规范的论证，也就是质量标准的合理性说明
specification limits :质量标准的限度，也就是各项的限度
product specification ：翻译为产品规范，也就是我们说的产品质量标准
可以参照下列ICH的原稿和中文译稿理解：
Specification:
A list of tests, references to analytical procedures, and appropriate acceptance criteria which are numerical limits, ranges, or other criteria for the tests described. It establishes the set of criteria to which a drug substance or drug product should conform to be considered acceptable for its intended use. "Conformance to specifications" means that the drug substance and / or drug product, when tested according to the listed analytical procedures, will meet the listed acceptance criteria. Specifications are critical quality standards that are proposed and justified by the manufacturer and approved by regulatory authorities.
规范 规范由一系列的试验、有关分析方法和认可标准组成，这些标准以限度值、范围或其他描述来表示。它建立了一套新原料药和制剂都必须遵循的、与其用途相适应的标准。
“符合规范”是指原料药和制剂按照给定的方法试验，符合认可标准。规范是重要的质量标准，它由生产商提出和验证、管理机构批准，并作为批准产品的依据。
楼上各位！