SOP for OS and OOT(中英文).docVIP

Purpose 目的 To describe the procedures and responsibilities for handling of results, generated in Microbiological Laboratory, which are either OOS (Out of Specification) or OOT (Out of Trend). 描述微生物实验室中产生的OOS（超标）或OOT（超趋势）结果的处理程序及职责。 Scope 范围 General 总则 OOS/OOT results obtained from analysis of API’s, finished products and raw material including water used in the production but with the following exceptions. OOS/OOT结果从原料药、成品和包括生产用水在内的原料的分析中得到，以下情况例外。 Exceptions and special cases 例外和特殊情况 Non-confirming positive and negative controls 非确认的阳性和阴性对照 Analyses where results from positive and/or negative controls are not affirmative can be repeated without further investigation. The laboratory documentation for the failed test must include a note as explanation. No further reporting. 阳性和阴性对照的结果分析是不肯定的，可以被重复测定，不需要进一步调查。失败的测试应在实验室文件中被解释说明。不需要进一步报告。 Discontinuation of analysis 分析的中止 Analysis can be discontinued due to errors in testing procedure or problems with equipment until the time of incubation. The laboratory documentation for the failed test must include a note as explanation. No further reporting. 由于检验程序的错误或者仪器的问题，可以中止分析。失败的测试应在实验室文件中被解释说明。不需要进一步报告。 Stability samples 稳定性样品 The first time a sample result exceeds a limit it is investigated according to this SOP. The retest result can provide information on whether the original result is not representative of the batch of samples taken out for stability. Provided that the result is not invalidated, confirmative OOS/OOT results later in the stability period will only be reported in the deviation handling system. 当样品结果首次超限时，按照此SOP进行调查。复测结果提供信息，证明是否原始结果对稳定性取样批次不具代表性。假如结果并非无效，那么在接下来的稳定性阶段中的确定的OOS/OOT结果将仅在偏差处理系统中被报告。 Intermediates from production 生产过程中的中间体 In general OOS/OOT results are not investigated according to this procedure unless otherwise specified in other relevant document. If so specified, the first time (defined as exceeding of limit after 3 normal test results for the sample point) a sample result exceeds a limit