摘要：介绍在药品生产过程中如何对OOS结果进行调查分析。结合美国药品OOS结果调查的行业指南，探讨在药品生产企业内出现OOS结果时进行调查的方法。在药品生产过程中，对OOS结果进行科学、及时、有效的调查是保证药品质量的重要工作。

    关键词：OOS；调查；CGMP

    中图分类号：TQ460.6文献标识码：A文章编号：1672-979X(2008)07-0070-04

    Investigation of OOS Results during Pharmaceutical Production

    HU Qian-qian, LIANG Yi

    (International Pharmaceutical Business School, China Pharmaceutical University, Jiangsu Nanjing 210009, China)

    Abstract：This paper introduces how to investigate and analyze the OOS results during pharmaceutical production. The investigation methods of OOS results in pharmaceutical factories were discussed by referring to the USA industry guidance for investigation of OOS results. During pharmaceutical production, the scientific, prompt and effective investigation of OOS results is an important task to ensure drug quality.

    Key words：OOS; investigation; CGMP

    OOS(out of specification)结果是指超出药品申请和审批文件、DMF文件(药物主文件)、药典以及企业标准的所有检验结果 ......