????GMP:???????(????)

????

??GMP??????????
- ??GMP????
- ??????(FDA)GMP????
????(QA)??
????(QC)??
??????
??????
??????
?????

????

21 CFR 210/211???FDA???GMP??,????????,????????,FDA???GMP????????,?????????????????????????????????GMP??,??,?GMP???????????????1978?GMP???????,?????????????,FDA?GMP??????????,??GMP??????,FDA????????GMP??????,??????????????????????GMP???????,??????????????GMP???

??????FDA??????,??????FDA????GMP???,???FDA???????(FDA-483?EIR)??????????????GMP?????????????

????

????????,???????GMP?????????????????????GMP???????FDA ???????,????????????????????????????????????FDA????????????GMP??,????????????????????????,????????????GMP???????FDA?????????????

????

???????21?210?211? - ?????????????
- 210? - cGMP??
- 211? - ??A:??
- 211? - ??B:?????
- 211? - ??C:?????
- 211? - ??D:??
- 211? - ??E:?????????????
- 211? - ??F:???????
- 211? - ??G:?????
- 211? - ??H:?????
- 211? - ??I:?????
- 211? - ??J:?????
- 211? - ??K:????????
??GMP??????FDA?????
?GMP?????????
????FDA???,????GMP???????
- GMP??
- FDA??
- FDA?????
- FDA????
- FDA??????
- ??FDA????
??FDA??????(FDA-483?EIR)?????????
????:GMP??????????