英国药监局OOS翻译 - 图文(3)

Investigation by Analyst and Supervisor

分析人及主管调查

Phase Ib Investigation – Initial Investigation conducted by the analyst and supervisor using the Laboratory Investigation Checklist 1b步骤调查-由分析人及主管使用实验室调查清单开展的最初调差。

? Contact Production/Contract Giver/QP/MAH as appropriate 视情况联系生产、供应商、质量受权人、药品批准文号持有者。

? For microbiological analysis where possible once a suspect result has been identified ensure all items related to the test failure are retained such as other environmental plates, dilutions, ampoules/vials of product, temperature data, autopipettes, reagents – growth media. No implicated test environmental plates should

be destroyed until the investigation has been completed. 对于微生物分析实验，一旦发现可以结果，应确保与本失败实验相关的所有物品得到保存，例如环境监测平皿、稀释液、产品安瓿或西林瓶、温度数据、自动吸样器、试剂-培养基。试验相关的环境监测平皿不得销毁，直到调查完成。

? The Analyst and Supervisor investigation should be restricted to data / equipment / analysis review only 分析人及主管调查应仅限于数据、仪器、分析过程回顾。

? On completion of the Analyst and Supervisor investigation

re-measurement can start once the hypothesis plan is documented and is only to support the investigation testing. 分析人及主管调查完成，一旦假设方案记录下来并且只支持调查试验，那么就可以再开始试验。

? This initial hypothesis testing can include the original working stock

solutions but should not include another preparation from the original sample (see: re-testing) 这个最初的假设试验从原始工作储备溶液开始，但是不包括从原始样品开始。

The checklist may not be all-inclusive, but should be a good guideline to cover the pertinent areas that need to be covered in any laboratory investigation:- 检查清单不可能非常详尽，但是应该是一个良好的指导，包括了在任何实验室调查中覆盖的相关方面。 - Correct test methodology followed e.g.. Version number.

是否遵循的正确的实验方法，例如所用的文件版本号

- Correct sample(s) taken/tested (check labels was it taken from correct place). 是否使用正确的样品或样品处理（检查样品标签，确认从正确的地方得到的样品）

- Sample Integrity maintained, correct container and chain of custody (was there an unusual event or problem). 样品保存的完好性，正确的容器及保管链（是否存在异常事件或问题？） - How were sample containers stored prior to use. 样品使用之前，样品容器如何存放？

- Correct sampling procedure followed e.g. version number. 是否遵循正确的取样程序，例如文件版本号。

- Assessment of the possibility that the sample contamination has occurred during the testing/ re-testing procedure (e.g. sample left open to air or unattended). 评估在实验或复检过程中样品污染的可能性（例如样品非受控开口存放）

- All equipment used in the testing is within calibration date. 所有使用的仪器均在校验期内。

- Review equipment log books. 回顾审核仪器使用维护记录

- Appropriate standards used in the analysis. 分析过程中是否使用合适的标准品。

- Standard(s) and/or control(s) performed as expected. 标准品或内控品的使用是否合规

- System suitability conditions met (those before analysis and during analysis). 是否达到系统适用性（那些分析之前的或者分析过程中的） - Correct and clean glassware used. 是否使用正确的、洁净的玻璃器皿？

- Correct pipette / volumetric flasks volumes used. 是否使用正确量程的吸管量瓶？

- Correct specification applied. 是否使用正确的说明书。

-Media/Reagents prepared according to procedure. 培养基、试剂是否按程序准备。

? Items were within expiry date 各试验物料是否在有效期内。

? A visual examination (solid and solution) reveals normal or abnormal appearance 是否肉眼检查（液体或固体）发现正常或非正常外观？ - Data acceptance criteria met 是否达到验收标准?

- 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

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