cGMP?? � ???/????

???????cGMP????????????FDA?cGMP??(21 CFR Part 210&211?/?ICH Q7????),?????????????????,??????????????????cGMP????????cGMP??????????,????????????????????????????????????,??????GMP???GMP???GMP????

???????cGMP????????????FDA?cGMP??(21 CFR Part 210&211?/?ICH Q7????),?????????????????,??????????????????cGMP????????cGMP??????????,? ???????????????????????????????????,??????GMP???GMP???GMP????

????

????cGMP?????????:
	�????GMP?? �??GMP?? �???????

???????:
	�?????????? �????????? �?????????

??????????:
	�?????? �???? �?????? �?????

????????????:
	�????????? �??????? �????? �????SOP

????????????cGMP????:
	�??????cGMP?? �?????? �??????

???????:
	�?????????? �?????? �??????????

???????:
	�???????? �?????????????

?????????:
	�???? �?????? 稧MP?SOP?? �????? �??????? �????(OOS)??

????

????FDA????????(PAI)
????FDA???????
????FDA?????(FDA-483)
????FDA????