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

??/???/???

• ?????
• ?????

????

• GMP???? - ??
• GLP???? - ?????
• GCP???? - ????
• IND???? - ??/???/?????
• ????????????????
• NDA???? - ??/???/???

????

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

• ??FDA cGMP??:???????(????)
• ??FDA cGMP??:?????(??????????)
• ??FDA cGMP??:???????
• ??FDA cGMP??:???????(????)
• ??FDA cGMP??:?????
• ??FDA cGMP??:??????????
• ??FDA cGMP??:?????
• ??FDA cGMP??:???????
• ??FDA????:??????
• ??FDA????:??????????
• ??FDA cGLP??:???????
• ??FDA cGCP??:???????
• ??FDA:??????????
• ??FDA:?????????????
• ??GMP?EMEA/FDA?????

* ??“??”????FDA?????GMP???????