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???I????????????FDA?cGMP????

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??:«?????»——“FDA?????????”

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2008?7?15?,?????????(FDA)?«????»(Federal Register)??????????,?????I????????????«????????»?21??211??cGMP?????(21 CFR Part 210&211),???????????«I????????cGMP??»???????????????2008?9?15??????

?????????,????FDA????????I????????cGMP??,??????????????????????FDA??????????????cGMP????????????,????????FDA?????????????????,???????“??”??I????????cGMP??,?????????????I???????????????

?1938??????«???????????»(FDCA)?,“?”???????????????,????????????????????????501(a)(2)(B)??????,???????????cGMP???FDA????????????,????????????????,?«????????»?21??210&211??,??1978????????,?“??”??????????????? (????) ???????????? (????????????),?????????????????????????????,????????????????,???????,?????????????????cGMP??????

??FDA??????????Janet Woodcock??,“FDA????????,??????????????????,?????????????????????????????”???,?cGMP????,FDA??????????????????????????????,????????????,????????GMP???????????????????????,?I????????GMP????,?II??????????????,???III????????,?GMP?????????????????

?????I????????GMP??,??????????????????????,????????????,FDA?2006?1?17??«????»?????????????,??????I???????????????«????????»?cGMP???????????,??????????,FDA???????«??????-I????????cGMP?????»?????,???????I??????????????????????????

?FDA??????????????????2006?5?2??«????»?????????????2008?7?15?,FDA?«????»???????????????????,???????????????????????????????????,?«????????»?21?210.2(c) ?????????I?????????????211???cGMP???????,FDA???????«I????????cGMP??»???,????????????????????????????I??????????????

????????,??????????????II??III???????????????,???I????????????????211???????????????FDA?????????????(IND)???????????(CMC)????????I??????????????????????FDA????????????????????????????,??FDA?????????,???????????????

??????I?????????????????,?????????II??III??????????????????????????«????????»????GMP????I???????????,?????????????????????????????????????????????????????????????,?????????/??/???????????????/????????????????,????I????????????????????????????,???????????????????????????????????,?????GMP??,????I???????????????????????????????????,??????????(??????,???????)??????????????????,???????????????

FDA??????????,??I????????cGMP????,????FDA??????“???”?????,??????????????????????????I??????????????«????????»211???cGMP??,????FDA??????“??”????????????GMP??,???????????????????????????????????????FDA?2006?1?17?????«????»???????????????????????(Direct Final Rule),????????????,?FDA?????????????,????«????»??????????????,???????????FDA??????????,??????????????,???«????»????????????????,???????????????FDA????????,????cGMP???????,?????????FDA????????????????????????FDA??????I???????cGMP??????????????????????,??FDA??????????????,FDA????????????????,????????????????,??????????????????????,????????,????????I????????????,FDA?????????????,???2?????????????,??????????????????????

????,????FDA???????????????????,???????????????????????FDA???????????????????,?????????????????????????

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????????????????????????????????,2007?10?1?????«????????»????????,????????????«??????????»?????????????????«??????????»???;???2003?9?1?????«????????????»?????????,?????????,????«??????????»?????,?????????????????????,?????????????????

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