???/??GMP??

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

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

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

????QSR/GMP??

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

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