翻译完稿 GUIDE TO INSPECTIONS OF PHARMACEUTICAL QUALITY CONT(5)

investigation of these batches and products, and any corrective action. 列出可能受影响的其他批处理和产品，这些批处理和产品以及任何纠正行动的调查结果。

Specifically:examine other batches of product made by the errant employee or machine

特别是：检查由于员工或机器的错误引起的其他批次的产品 examine other products produced by the errant process or operation 检查由于错误的工序或操作引起的其他批次产品

4. Preserve the comments and signatures of all production and quality control personnel who conducted the investigation and approved any reprocessed material after additional testing

5. 质量控制人员负责引导调查和批准额外测试后原辅料在加工的批准。所有的产品和质量控制人员的意见和签名都要保留。 ------------------------------------------------------------------------------------王敏 Analyst's mistakes, such as undetected calculation errors, should be specified with particularity and supported by evidence.

分析人员的错误，如未被发现计算错误，应指定的特殊性和证据支持。 Investigations along with conclusions reached must be preserved with written documentation that enumerates each step of the investigation.

调查并得出结论必须保留与列举调查的每个步骤的书面文件。 The evaluation, conclusion and corrective action, if any, should be

preserved in an investigation or failure report and placed into a central file. 评价、 结论和采取纠正行动，如果有的话，应保存在调查或故障报告，并放置到一个档案文件。

E. INVESTIGATION TIME FRAMES E.调查的时间框架

All failure investigations should be performed within 20 business days of the problem's occurrence and recorded and written into a failure or investigation report.

20个工作日内，对问题的发生，所有故障应进行调查和记录，并写入故障或调查报告。 6.

PRODUCT FAILURES 产品的故障

An OOS laboratory result can be overcome (invalidated) when laboratory error has been documented.

一个OOS实验室的结果是可以克服的（无效），实验室错误已被记录。 However, non-process and process related errors resulting from operators making mistakes, equipment (other than laboratory equipment)

malfunctions, or a manufacturing process that is fundamentally deficient, such as an improper mixing time, represent product failures.