美国药典35版USP 1225 VALIDATION OF COMPENDIAL PROCEDURES.pdf,Accessed from 46.201.206.156 by boyo3 on Wed May 16 18:53:54 EDT 2012 USP 35 General Information / 〈1225〉 Validation of Compendial Procedures 877 ELEMENTS RECOMMENDED FOR THE It is recomm
内容提示: 验证: Validation 针对新方法(没有法定方法, 需要用户自己建立的) 按照 ICH Q2 或 USP<1225>的方式均可; 主要是需要满足使用目的. <1225>VALIDATION OF COMPENDIAL PROCEDURES 药典规程的验证 Test procedures for assessment of the quality levels of pharmaceutical articles are subject to various ...
supported by sucient laboratory data to document their validity. The text of this information chapter harmonizes, to the extent possible, with the International Council for Harmonisation (ICH) tripartite guideline Validation of Analytical Procedures and the Methodology extension text, which are concerned...
defined in the next section of this chapter, along with a delineation of a typical method or methods by which it may be measured. 分析规程的验证是,通过实验室研究,确定该规程的工作特性达到了预定分析用途要求的过程。 在此文件中所描述的规程种类的验证中,应当考虑的常见分析工作特性在表1 中列出。因...
认识到USP和NF标准的法律地位，因此，提议采纳新的或更改过的药典分析规程时，以充分的实验室数据作为支持，以记录其有效性，成为基本要求。The text of this information chapter harmonizes, to the extent possible, with the Tripartite International Conference on Harmonization (ICH) documents Validation of ...
认识到USP和NF标准的法律地位，因此，提议采纳新的或更改过的药典分析规程时，以充分的实验室数据作为支持，以记录其有效性，成为基本要求。The text of this information chapter harmonizes, to the extent possible, with the Tripartite International Conference on Harmonization (ICH) documents Validation of ...
16、 respect to terminology and use, each of the performance characteristics is defined in the next section of this chapter, along with a delineation of a typical method or methods by which it may be measured. 分析规程的验证是,通过实验室研究,确定该规程的工作特性达到了预定分析用途要求的过程。
USP39 General Chapter <1225> Validation of Compendial Procedures
9. Ful l val idation data in compl iance with General Chapter<1225>Validation of Compendial Methods are required for al l tests,when there is no USP–NFmonograph
USP-化学药物质量控制分析方法验证技术指导原则 1225 VALIDATION OF COMPENDIAL PROCEDURES Test procedures for assessment of the quality levels of pharmaceutical articles are subject to various requirements. According to Section 501 of the Federal Food, Drug, and Cosmetic Act, assays and specifications in ...