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????2??????,???????????FDA????????(21 CFR Part 820????),?????????QSR/cGMP?????????FDA?GHTF???????????????,??QSIT?,????? ????GMP???????????,??????????????????????,?????????????????
??,?????????????????,?????????????????????????????????, ????????????????????????,???????????????QSR/cGMP???????(21 CFR Part 820 Quality System Regulation),?????FDA???????????
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