美国FDA关于实验室检验超标结果调查程序简介

Introduction of FDA Investigation Procedure about Outing of Specification

目的简介美国FDA对药品生产企业实验室出现检验超标结果如何进行调查的程序。方法找到实验室检验超标结果出现的原因,避免类似情况再次发生。结果与结论实验室检测结果偏离标准是常出现的问题,随意处理将带来极大的潜在风险。进行科学、及时、有效的调查处理是十分必要的。

Objective To introduce the United States FDA investigation procedure about OOS.Methods To find the results of OOS to prevent similar situations from happening again.Results and Conclusion The results of laboratory test often deviate from the standard.Handling at random will bring a great deal of potential risks.Scientific,timely and effective investigation and handling are very necessary.