???GMP??

• ???GMP?? - ???/??GMP??
• ???GMP?? - ????QSR/GMP??
• ???GMP?? - ?????GMP??

???GMP?? - ???/??GMP??

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

?????????GMP??,?????????2?????????3????,???????????????????????????????GMP?????

?????????????GMP??????????,????????????,??????????,???cGMP???????,??????????GMP????????,????GMP?????

???GMP?? - ????QSR/GMP??

????????????QSR/GMP????????FDA?cGMP??(21 CFR Part 820????),?????????????????,?????????????????????cGMP???,???????????????? ????,??????,????????

?????????????QSR/GMP??????????,????????????,??????????,???QSR/GMP???????,??????????QSR/GMP????????,????QSR/GMP?????

???GMP?? - ?????GMP??

????????????GMP????????FDA?cGMP??(21 CFR Part 110 ?21 CFR Part 111????),?????????????????,?????????????????????cGMP???,???????????????? ????,??????,????????

?????????GMP??,?????????2?????????3????,?????????????????????????????????????

?????????????GMP??????????,????????????,??????????,???cGMP???????,??????????GMP????????,????GMP?????

? ?????“????”??,?????????