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04.10.2017

Comprehensive Document about the Handling of OOEand OOT Results

OOE和OOT結果處理的綜合文件

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.

制藥行業(yè)中的OOE和OOT結果要怎么樣記錄和評估？要回答此問(wèn)題，ECA的QC工作組及官方和行業(yè)代表匯編了一份如何處理超出預期（OOE）和超出趨勢（OOT）結果的指南文件。

This 70 page document covers the followingissues:

這份70頁(yè)的文件包括以下問(wèn)題：

• Regulatory references

• 法規參考文獻

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

• 化驗室和分析過(guò)程中數據管理概覽

• Responsibilities for QC and QA

• QC和QA職責

• Purpose of trend analysis

• 趨勢分析的目的

• The concept of control charts

• 控制圖的概念

• Detection and handling of OOE results

• OOE結果的發(fā)現和處置

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

• 連續和離散數據的統計學(xué)過(guò)程控制（SPE）

• Techniques for the retrospective review of historical data

• 歷史數據的回顧性審核技巧

• Trend analysis in stability testing

• 穩定性測試中的趨勢分析

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.

該文件還包括7個(gè)附錄、1個(gè)技術(shù)術(shù)語(yǔ)和穩定性研究趨勢限度適當設定的最重要的統計學(xué)工具和回歸方法可視化計算實(shí)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.

所有參加2017年11月20-21日維也納“ECA的OOT結果處理課程”的人員均會(huì )收到一份該重要指南文件的副本。