|
New USP Chapter <1210> StatisticalTools for Procedure Validation 新的USP章<1210>使用统计工具进行工艺验证。 Following the draft forchapter <1210>, which was published in PharmacopeialForum (PF) 42(5) in September 2016, the United States Pharmacopeia (USP)adopted its new General Chapter <1210> Statistical Tools forProcedure Validation. The chapter has been published in USP 41-NF 36and becomes official on May 1, 2018. 美国药典(USP)于2016年9月在药典论坛(PF) 42(5)上发表了<1210>>的草案后，采用了新的通用章节<1210>统计工具进行工艺验证。这一章已在USP 41-NF36上发表，并于2018年5月1日正式生效。 The chapter describes the utilization of statistical approaches inprocedure validation as described in Validation of Compendial Procedures<1225>. “Procedure validation” in this context refers to the analyticalprocedure qualification stage of the three stages of the analyticalmethod life cycle, following design and development andprior to testing. 这一章描述了在工艺验证中使用统计方法的情况，如对药典方法的验证<1225>。在此背景下的“方法验证”是指分析方法生命周期的三个阶段：设计、开发和测试阶段的分析方法确定阶段。 In the threestages of the analytical procedure lifecycle the validation step must provideevidence of a procedure's fitness for use. 在分析方法生命周期的三个阶段中，验证步骤必须提供一个方法适合使用的证据。 More informationcan be found in the new USP general chapter <1210> Statistical Toolsfor Procedure Validation published in USP 41-NF 36. 更多的信息可以登录USP官网查看。 英文节选自ECA新闻，请以英文为主，翻译仅供参考。
|
|
|
