摘要
在药品生产过程中出现OOS,必须及时地进行科学、有效的OOS结果调查,保证药品质量。现结合美国FDA药品OOS结果调查的行业指南,探讨了如何在药品生产企业进行OOS的调查,以寻找药品生产过程中OOS结果调查的有效途径。
Investigating OOS results in time in a scientific and effective way during drug production is an important task to assure drug quality. The methods of investigation of OOS results in pharmaceutical factories were discussed after referring to industry guidance of FDA. To find an effective path to how to investigate OOS results during drug manufacturing.
