英国药监局OOS翻译 - 图文

- The analyst is trained on the method. 分析人是否接受过该方法培训？

- Interview analyst to assess knowledge of the correct procedure. 与分析人面谈，评估其对正确程序的掌握程度。

- Examination of the raw data, including chromatograms and spectra; any anomalous or suspect peaks or data. 原始数据检查，包括色谱或者光谱分析数据、任何异常的或可以的峰或数据。 - Any previous issues with this assay. 回顾这项分析以前发生的所有问题。

- Other potentially interfering testing/activities occurring at the time of the test. 是否在实验阶段出现潜在的干扰实验或者实验活动的事情发生？

- Any issues with environmental temperature/humidity within the area whilst the test was conducted. 实验过程中是否存在该区域温湿度问题？

- Review of other data for other batches performed within the same analysis set. 回顾分析使用相同分析设置的其他批次数据。

- Consideration of any other OOS results obtained on the batch of material under test. 考虑该批物料检验时发现的其他项目OOS结果。 - Assessment of method validation. 方法验证评估。

Additional considerations for microbiological analysis: 微生物检验的其他附加考虑：

- Are the isolates located as expected – on glove dab marks, SAS ?dimples‘, filter membrane etc. 是否按要求隔离放置-手套印记平皿，SAS ?dimples‘滤膜等。

- Was the sample media integral – i.e. no cracks in plates.

- Was there contamination present in other tests (or related tests) performed at the same time, including environmental controls. 采样培养基是否完整-即平皿未皲裂； 在其他同时间开展的试验中是否也存在同类污染，包括环境控制。 - Were negative and positive controls satisfactory. 是否阳性及阴性控制均合格？

- Were the correct media/reagents used. 是否使用正确的培养基或试剂？

- Were the samples integral (not leaking) 样品是否完整（没有倾洒）

- Were the samples stored correctly (refrigerated) 样品是否正确储存（冷藏的）

- Were the samples held for the correct time before being tested. 实验前，样品是否时间受控？

- Was the media/reagent stored correctly before use

使用之前，培养基/试剂是否正确贮存。

- Were the incubation conditions satisfactory. 培养条件是否适当？

- Take photographs to document the samples at time of reading (include lates, gram stains and any thing else that may be relevant). 将样品的结果以照片的形式附在记录中