Out Of Specification Investigation OOS调查
This is a guidance document that details the MHRA expectations
这是一个详述MHRA期望的指导文件
Note: This guidance is complementary to FDA Guidance For Industry Investigating Out-Of-Specification (OOS) Test Results for Pharmaceutical Production October 2006.
注：这个指导原则是“FDA药品OOS试验结果工业调查 2006年十月”的补充。
Updated to include Microbiological expectations 本更新包括微生物学调查期望