20171004 ECA新闻：OOE和OOT结果处理的综合文件

04.10.2017

Comprehensive Document about the Handling of OOEand OOT Results

OOE和OOT结果处理的综合文件

How are OOE and OOT results in the pharmaceuticalindustry to be recorded and assessed nowadays? To answer this question, the ECAQuality Control Working Group and representatives from authorities and industrycompiled a guidance document about the handling of Out-of-Expectation (OOE) andOut-of-Trend (OOT) results.

制药行业中的OOE和OOT结果要怎么样记录和评估？要回答此问题，ECA的QC工作组及官方和行业代表汇编了一份如何处理超出预期（OOE）和超出趋势（OOT）结果的指南文件。

This 70 page document covers the followingissues:

这份70页的文件包括以下问题：

• Regulatory references

• 法规参考文献

• Overview of data management in the laboratory and the analytical     process

• 化验室和分析过程中数据管理概览

• Responsibilities for QC and QA

• QC和QA职责

• Purpose of trend analysis

• 趋势分析的目的

• The concept of control charts

• 控制图的概念

• Detection and handling of OOE results

• OOE结果的发现和处置

• Statistical process control (SPC) of continuous and discrete data

• 连续和离散数据的统计学过程控制（SPE）

• Techniques for the retrospective review of historical data

• 历史数据的回顾性审核技巧

• Trend analysis in stability testing

• 稳定性测试中的趋势分析

This document also includes seven Annexes; atechnical glossary and worked examples to visualize the most importantstatistical tools and regression methods for a proper setting of stabilitytrend limits.

该文件还包括7个附录、1个技术术语和稳定性研究趋势限度适当设定的最重要的统计学工具和回归方法可视化计算实例。

All participants of the 'ECA Education Courses HandlingOOT-Out-of-Trend Results' on 20-21 November 2017 in Vienna willreceive a copy of this important guidance document.

所有参加2017年11月20-21日维也纳“ECA的OOT结果处理课程”的人员均会收到一份该重要指南文件的副本。