ÄúÏÖÔÚµÄλÖãºÊ×Ò³ > 2010???????

2010???????

????2010???????2010???????2010???????2010???????2010???????2010???????2010???????2010???????2010???

????2010??GMP??????????????,?GMP????,????????GMP?????????GMP????????????????,???GMP?????GMP?????????????GMP?????????

????2010?GMP??????????????????GMP????PharmaNet???3????? ???????GMP????????????????GMP??,??????????????,??PharmaNet???????GMP?? John Lee ??????????????,???????FDA????????????????????????GMP???????????????????? ???????????????GMP????????

?????????????????GMP???,?????“??FDA GMP??:???????(???)”,????????????????????????????????GMP??,???????FDA?GMP ?????????????????????????????????????????,??????????????????GMP????,???? ???????????

??,????????????????GMP??????????????????????????????????????????????????GMP???????????GMP??????

???????????,?2009?????????????,???“??FDA QSR/GMP??:???????(????)”??????,??????????QSR/GMP?????,??“??FDA QSR/cGMP??:????”,“??FDA QSR/cGMP??:???????(CAPA)”????????????????????

???,??????????????????,???????????????????????????,???? ??GMP?????,??????????????????,??????????????????????????,??????????????? ??????,?????????????????,?????“??FDA cGMP??:???????”????,?????????????????,????????????????

?????GMP??,????????,???????,??????????,??????GMP??????

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