20141001 ECA新闻：ECA SOP：识别生产和QC趋势的方法(Julia翻译）

巴西木

GMP News
08/10/2014

ECA SOP: Methods for the Identification of Trends in Production and QC

ECA SOP：识别生产和QC趋势的方法

      After the creation of an SOP on Out-of-Specification results, ECA Working Group on Analytical Quality Control's next objective is the elaboration of an SOP on methods for statistical process control with regard to the statistical evaluation of the variability of production processes. The analysis of trends in stability studies will also be part of this SOP. Moreover, the handling of Out-of-Expectation (OOE) results will be addressed in this SOP, too.

      在创建了OOS结果的SOP后，分析质量控制ECA工作组的下一个目标是制订一份关于统计评估生产工艺变动情况的统计流程控制方法SOP。对稳定性数据的趋势分析也会是该SOP的一部分。另外，OOE结果的处理也会在该SOP中进行说明。

Among other things, the following methods and working examples will be considered:

在其它事情中，还将考虑的是以下方法和工作样例：

1. Investigation of trends for statistical process control: 统计学过程控制趋势调查
Statistical process control for continuous data: 连续性数据的统计学过程控制

    a. Shewhart Charts 休哈特控制图
    b. CuSum & Zone Charts 积累管理图
    c. Post Mortem CuSum Analysis  事后积累分析

2. Statistical process controls for discrete data: p and c Charts 具体数据的统计学过程控制：p和c图

3. Trend analysis for stability testing: 稳定性数据的趋势分析
   a. Simplified procedure 简化程序
   b. More complex procedure using the "Random Coefficients" approach. 采用“随机因子”的更复杂的程序

     All delegates of the OOT Forum on 22 - 23 October 2014 in Prague, Czech Republic, will receive the outline of the draft version of ECA Working Group on Analytical Quality Control's SOP on OOE and OOT Results. The outputs from the workshops at the OOT Forum will provide the scope for the content of the draft guidance. The participants will receive the draft guidance after the team has put it together sometime after the Forum as defined as the next steps for this project.

      所有OOT论坛的代表将收到ECA分析质量控制工作组关于OOE和OOT结果的SOP草案。工作组在OOT论坛上将提供指南草案内容的范围，按已制订的本项目下一步计划，与会者将在论坛结束后一段时间收到工作组将内容整合后的指南草案。

道路漫长黑暗

巴版有没有这个OOS的SOP分享下啊

一沙一叶

可惜没有案例介绍

君瀹

oot和ooe的区别和联系谁能给解释一下不？

罗伊鲱

好像就是Laboratory Data Management Guidance
OUT OF EXPECTATION (OOE) AND OUT OF TREND (OOT) RESULTS

小金库

感谢分享。