Rather than repeating information, can only the information of reference standards be provided in 3.2.S.5 once the same information is include in 3.2.P.6?

刊登日期:2019-11-13  |  點閱次數 : 1578 次 

The information on all reference standards or materials for drug product should be provided in 3.2.P.6. A cross reference from 3.2.S.5 can be provided to support 3.2.P.6 if the information of reference standards is identical.



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