2014?5?28??29?CHhI??????“??????2014”,???????????,????“????????(QbD)?????”?“????”????,??????????????,????????????,???????????,????????????????????(Blue Bell Consulting)???????????????????,???“????????(QbD)?????”?????
?????,????“??????(QbD) - FDA??”?????,??????????????FDA?ICH?????,?????QbD????????????FDA/EMA????,?????2014?1??FDA??????????ANDA???????FDA?QbR????????????????????????????GMP????????????