英国药监局OOS翻译 - 图文

Phase la Investigation

Definition定义:

? Phase la investigation is to determine whether there has been a clear obvious errors due to external circumstances such as power failure or those that the analyst has detected prior to generating data such as spilling sample that will negate the requirement of a Phase Ib investigation.

? For microbiological analysis this may be after the analysis has been completed and reviewed during reading of the samples.

? It is expected that these issues are trended even if a laboratory investigation lb or ll was not raised.

步骤1a的调查时确定是否有明显的错误来源于外部环境比如停电或者生成数据之前检测者发现的那些失误如撒样品，这样就可以否定开展1b调查步骤。

对于微生物分析，这一点可能需要在分析完成后回顾样品的操作。 期望这些问题是有趋势可循的，即使实验室调查步骤1b或者ll没有开展。

Phase la Investigation - Obvious Error

步骤1a调查-明显错误

Examples样品

? Calculation error – 计算错误

analyst and supervisor to review, both initial and date correction. 分析人员及主管回顾，修正后签名及日期。 ? Power outage –断电

analyst and supervisor document the event, annotate ―power failure; analysis to be repeated‖ on all associated analytical documentation. 分析人及主管记录这一事件，并注明“断电，需复检”在所有关联的分析记录中。 ? Equipment failure –仪器错误

analyst and supervisor document the event, annotate ―equipment failure; analysis to be repeated‖ cross reference the maintenance record. 分析人及主管记录这一事件，注明―仪器错误，需复检‖并索引至仪器维护记录。 ? Testing errors –试验错误

for example, spilling of the sample solution, incomplete transfer of a sample; the analyst must document immediately.

for microbiology it could be growth on a plate not in the test sample area, negative or positive controls failing. 例如，样品溶液倾洒，样品转移不完全；分析人应立即记录。 对于微生物分析，可能出现微生物生长在非样品区域的平皿中，阴性或阳性对照失败。

? Incorrect Instrument Parameters –错误的仪器参数设置

for example setting the detector at the wrong wavelength, analyst and

supervisor document the event, annotate ―incorrect instrument parameter‖; analysis to be repeated‖ on all associated analytical documentation . 例如，检测器波长设置错误，分析人及主管记录这一事件，注明“错误的仪器参数，需复检”在所有关联的分析记录中。

? If no error was noted, and none of the above conditions were met Phase Ib investigation must take place. 如果没有错误被记录，上述条件都没有发生，应开展步骤1b调查