With regards to Items 6 and 12 of CMC drug product section on the ANDA Refuse to File (RTF) checklist, if analytical methods for a drug substance and a drug product follow pharmacopeia monographs, is it acceptable to provide copies of pharmacopeia monographs instead of instrumental parameters and method calculations?
刊登日期：2021-11-17 | 點閱次數 : 478 次
No. The analytical procedures in pharmacopeia monographs usually only include descriptions of analytical principles, or denote relevant sections in the general chapters, and there might be several analytical methods included in a general chapter of pharmacopeia. Therefore, the analytical method followed by manufacturer which includes analytical conditions, solution preparations and calculations, etc. should be provided.
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