FDA关于OOS的警告信

摘要：OOS调查是继数据可靠性这个大热点话题之后的一个热门的话题，笔者查询了2018年 FDA 生产质量办公室发布的全部49封警告信及之前相关的警告信，将OOS相关的警告信进行了归类总结。一、OOS调查的适用范围OOS，顾名思义，OOS, OUT OF SPECIFICATION,超出标准。但超出哪些标准需要启动OOS调查呢？我们先来看看法规对此的规定。Guidance for Industry Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production FDA 2006年10月颁布This guidance for industry provides the Agency’s current thinking on how to evaluate out-ofspecification (OOS) test results. For purposes of this document, the term OOS results includes all test results that fall outside the specifications or acceptance criteria established in drug applications, drug master files (DMFs), official ………………………………