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What is the difference between OOS / OOE / OOT?  

2014-09-19 08:00:04|  分类: 工作【GMP知识】 |  标签: |举报 |字号 订阅

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What is the difference between OOS / OOE / OOT?
OOS/OOE/OOT有什么不同?
The terms OOS, OOE and OOT always emerge in connection with the handling of deviating analysis results. But what are their definitions?
术语OOS、OOE和OOT都是处理分析结果偏差中的概念,那他们的定义是什么呢?
For some time, ECA's Quality Control Working Group has published a SOP on the handling of OOS results and is currently planning the elaboration of a SOP on OOE and OOT. The OOS SOP respectively the draft of the OOT SOP contains the following definitions for the three terms:
ECA的质量控制工作组曾经公布过一份关于处理OOS结果的SOP,目前他们正在计划起草一份关于OOE和OOT的SOP。OOT的SOP草案中包括了对三个术语的以下定义:
Out-of-Specification (OOS) Results 超标结果(OOS)
A result that falls outside established acceptance criteria which have been established in official compendia and/or by company documentation.
结果超出了由官方药典和/或公司文件既定的可接受标准。
Out-of-Expectation (OOE) Results 超期望结果(OOE)
An atypical, aberrant or anomalous result within a series of results obtained over a short period of time is an OOE result. An OOE result is a result that meets specifications, but is outside the expected variability of the analytical procedure.
在一个短时期内得到的一系列结果中的一个非典型、异常结果。一个OOE结果符合质量标准,但超出检验方法所期望的变动范围。
Out of Trend (OOT) Results 超趋势结果(OOT)
A time dependent result which falls outside a prediction interval or fails a statistical process control criterion.
与时间相关的结果,它超出预期的间隔或未能符合统计学控制标准。
A trend is a sequence of temporal procedures, e.g. for the manufacture of different batches of a product. There are two types of trends:
趋势是一个随时间而变化的序列,例如,不同批次产品的生产。趋势有两种类型:
In one case, no trend is expected, e.g. in production or when analysing process data where everyone expects that they are under statistical control.
一种情况,不期望产生一种趋势,例如,在生产过程中或分析过程中,每个人都期望这些数据在统计学控制范围内。
In the other case, a trend is expected. One typical example for that is stability testing where one expects that the content of the API reduces over the storage period, or that the quantity of impurities increases over time.
另一种情况,预期有一种趋势。一个典型的例子是稳定性研究中,会预期原料药的含量随着存贮时间延长而降低,或杂质会随时间延长而增加。
There is a fundamental difference between these two types of OOT results: indeed, in the second situation the dispersion increases over time.
这两类OOT结果之间有根本的差异,事实上,第二种情形下数据的离散度随时间而增加。
The new Chapter 5 of the EU GMP Guide - coming into force on 1st October 2014 - requires that in future certain data have to be recorded so that trends can be recognized and assessed.
在EU GMP指南的第5章中(将于2014年10月1日生效),要求将来对特定的数据进行记录,这样可以发现其趋势并进行评估。
PS: At the OOT Forum organised by ECA's QC Working Group from 22 -23 October 2014 in Prague, Czech Republic, ECA's draft SOP on OOE and OOT results will be presented.
另:在2014年10月22-23日ECA的QC工作组组织的OOT论坛中,ECA的OOE和OOT的SOP草案将会展示给大家。
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