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

???/????

????????????????????????????????????????????????????????

????

• GMP???? - ??
• GCP???? - ????
• ???????????????
• ANDA???? - ???/????

????

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

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

* ??“??”????FDA?????GMP???????