英国药监局OOS翻译 - 图文(2)

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

Phase Ib Investigation – Definitions定义

Specification –标准

A specification is defined as a list of tests, references to analytical procedures, and appropriate acceptance criteria which are numerical limits, ranges, or other criteria for the tests described. It establishes the set of criteria to which a drug substance, drug product or materials at other stages of its manufacture should conform to be considered acceptable for its intended use. ―Conformance to specification‖ means that the drug substance and drug product, when tested according to the listed analytical procedures, will meet the acceptance criteria. Specifications are critical quality standards that are proposed and justified by the manufacturer and approved by regulatory authorities as conditions of approval.

标准被定义为一组测试，参照分析程序，及适当的接受条件，这些标准应为数字限度、范围或这一组测试描述的其他条件。建立的这套在生产过程各阶段的药物、药品或材料的标准，如果达到，应当被认为就符合其预定用途。“符合标准”意味着药物以及药品，当按照这套分析程序检验，达到了可接受条件。标准是判定性的质量标准，它是有生产厂家提出并证实，由法规机构作为批准条件颁发的。

? Regulatory Approved Specification –法定标准

Specifications for release testing. If no release specifications have been established then the internal specification becomes the release specification. 放行试验标准。如果没有放行标准被建立，那么中间控制标准即为放行标准。 ? Acceptance Criteria –可接受标准

Numerical limits, ranges, or other suitable measures for acceptance of the results of analytical procedures which the drug substance or drug product or materials at other stages of their manufacture should meet. 生产各过程的药物、药品或物料应当符合限度、范围或者分析过程结果的其他合适的可接受方式。 ? Internal Specification –中间标准

Are also action limits within regulatory specifications. 法定限度内的行动线。

Assignable Cause –明确原因

An identified reason for obtaining an OOS or berrant/anomalous result. 出现OOS或者异常结果的被确定的原因

? No Assignable Cause –非明确原因

When no reason could be identified.无法确定的原因 ? Invalidated test –无效实验

A test is considered invalid when the investigation has determined the assignable cause. 经调查确定可指明原因，试验被认为无效。 ? Reportable result –可报告结果

Is the final analytical result. This result is appropriately defined in the written approved test method and derived from one full execution of that method,

starting from the original sample. 为最终分析结果。使用书面的批准方法适当的明确并且从这一方法完整执行后得到的结果，此结果从原始样品的检测结果。 ? Warning Level or Trend excursions –警戒水平或者趋势偏离

If two or more consecutive samples exceed warning (alert), or if an increasing level of counts, or same organisms identified, over a short period was identified consideration should be given to treat the results as action level excursions. 如果两个或者更多的连续取样样品超出警戒，或者如果出现数量水平的持续增加，或者相同的微生物被鉴定出来，极短时间得到鉴定，应该被认作行动水平偏离导致的结果。

Hypothesis/Investigative Testing –假设/调查试验

Is testing performed to help confirm or discount a possible root cause i.e what might have happened that can be tested:- for example it may include further testing regarding s …… 此处隐藏：3211字，全部文档内容请下载后查看。喜欢就下载吧 ……