2010?3?8??9?,???????????????????«??FDA cGMP??:???????(??)»?GMP????????GMP?????????40?,????????????,????????,???????????????????????????10??????GMP????
?????GMP????,???????????PharmaNet????????(??????????????????)?????????,???????FDA???????????????????GMP???,??????????????,??PharmaNet???????GMP??John Lee ??????????????,??????????????
???,John Lee????????????FDA GMP???????????,???????GMP??(21 CFR Part 210 & 211)??????,??????(Preamble)???????????????FDA-483???????FDA???,?????FDA????GMP????????????????????,????????????????????,????????????????????,??????????????????FDA GMP???????????,??FDA???????????,????????????,???????????????????????
??GMP????????????????,????????????????????????FDA GMP???GMP????????????????????
