2015年9月12日 · This document summarizes a presentation on handling out-of-specification (OOS) results from a scientific and regulatory perspective. It discusses the history of an OOS case involving Barr Laboratories, the phenomena and scenarios surrounding OOS results, and how to conduct OOS investigations.

2021年5月6日 · This document discusses out of specification (OOS) results and the processes for investigating them. It covers: 1) What OOS is and when investigations are conducted. 2) The initial laboratory investigation and the responsibilities of the analyst and supervisor.

•The Barr Decision made the OOS problem into a major update for the QC laboratory by creating a regulatory requirement where, following an OOS result, an investigation must be initiated before any retesting can be done. •Since the Barr case the US FDA has led the way in defining standards for the investigation of

精选ppt 目的是确定OOS或OOE结果的有效性或是归因于实验室误差。 1、原始数据的审核：如系统适用性等； 2、实验方法； 3、仪器的检查：只有符合方法要求及经过校正合格的仪器才 可使用。

2014年10月30日 · OOS / OOT Result (1) • Out-of-Specification (OOS) Result – Test result that does not comply with the predetermined acceptance criteria, for example: - filed applications, drug master files, approved marketing submissions, - official compendia - …

Laboratory Analysis Investigations of "Out of Specification (OOS) / Out of Trend (OOT)/ Atypical results" have to be done in cases of: Batch release testing and testing of starting materials. In-Process Control testing: if data is used for batch calculations/decisions and if in a dossier and on Certificates of Analysis.

“OOS结果的实验室调查〞, SOP# xxx 没有规定复验的允许次数. 必要的改正措施，以及其它具有类似情况的 批号的总结，也没有对具有类似情况的其他 产品的总结。 只进展单点校正? 缺少批号的记录 温度补偿?

2018年1月2日 · 内容提示： 实验室超标结果处理（oos） ） 文档格式：PPT | 页数：50 | 浏览次数：246 | 上传日期：2018-01-02 21:56:29 | 文档星级：

2014年11月13日 · This document summarizes a presentation on handling out-of-specification (OOS) results from a scientific and regulatory perspective. It discusses the history of an OOS case involving Barr Laboratories, the phenomena and scenarios surrounding OOS results, and how to conduct OOS investigations.

oos：是超出规格标准的结果。简称超标调 查。 oot：为偏离趋势的结果,但结果应符合规 定。即超出正常范围,但在标准规定以内就 为oot 。简称超常调查。 偏向：从广义上说，与预期不符即是偏差。 oos/oot与偏差的区别 从以上定义可以看出，oos/oot都属于偏差的范 ...