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 negati