The aim of the validation report is to explain the operations performed in order to provide the documented evidence that the manufacturing process of Gemcitabine provides consistenly, with a high degree of assurance the production of an API meeting its predetermined specifications and quality attributes. 验证报告的目的是去解释所做的操作,目的是为了提供文件根据,证明吉西的制造工艺能提供坚固的,高水平的,能满足它的预定规格和质量品质的原料产品.
All the production and analytical data of the validation lots have to be checked in order to verify that the operating parameters are consistenly within the predetermined ranges as identified during the development of the process, verify that the characteristics of the API meet consistently the predetermined specifiactions and verify that the impurity profile of the three validation lots is equivalent 所有的产品和验证批的分析数据必须检查,为了核实运行参数在工艺的发展期如鉴定的一样,在预定范围内是一致的,核实API的特征满足统一的预定规格,核实三个验证批的杂质分布图是等价的.
The aim of the validation report is to explain the operations performed in order to provide the documented evidence that the manufacturing process of Gemcitabine provides consistenly, with a high degree of assurance the production of an API meeting its predetermined specifications and quality attributes. 验证报告的目的是去解释所做的操作,目的是为了提供文件根据,证明吉西的制造工艺能提供坚固的,高水平的,能满足它的预定规格和质量品质的原料产品.
The aim of the validation report is to explain the operations performed in order to 感觉英文原文有点重复，后面的in order to如果改为and会好理解一些。 验证报告的目的是解释所有操作并提供文本依据，证明吉西的制造工艺能高度确保提供的原料药能持续满足它的预定标准和质量参数.
原文由 cuggi_liang 发表: The aim of the validation report is to explain the operations performed in order to provide the documented evidence......
验证报告的目的是去解释所做的操作,目的是为了提供文件根据......
Definition of document (v.) : 1. To furnish with a document or documents. 2. To support (an assertion or claim, for example) with evidence or decisive information. 3. To support (statements in a book, for example) with written references or citations;
Definition of documented (adj.) : furnished with or supported by documents; "the first documented case of shark attack in those waters"
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