FDA???GMP????????/???????

???/???????

• ???????????????????????????
• ????
• ?????????????????????????

????

• GMP???? - ??
• DMF???? - ???/???????

????

???????????????????????FDA?????GMP??:

• ??FDA cGMP??:???????(????)
• ??FDA cGMP??:?????(??????????)
• ??FDA cGMP??:???????
• ??FDA cGMP??:???????(????)
• ??FDA cGMP??:?????
• ??FDA cGMP??:??????????
• ??FDA cGMP??:?????
• ??FDA cGMP??:???????

* ??“??”????FDA?????GMP???????