2011?6?7??10?,??????????????????????????FDA????Douglas A. Campbell???????GMP??(Preapproval Inspection, PAI)?
????????(6?7?),????????????????????,??????????;????????,?????????????????;??????????????????????????????????,Campbell?????????????,???????????
???(6?8?)??,Campbell????????????????,??????????????????????,??????????????????????,????FDA“?????????”???Campbell????????????????,????????????????,?????????——???????????????????,?????????????????Campbell???????????????????????,Campbell?????????????,??????????????,????????,??????????????,?????????,????????????FDA??????????????,???????????????????,???????????????????
???(6?9?),Campbell???????????????????????????,?????????????????,??????,??????????,?????????????????????“????”?????????????????????????,????????????????????,??????????????????????????????,Campbell?????????????????????,???????????????FDA??????????????,??,????????????????????????
???(6?10?)??,?????????????Campbell???????????????????????,??????????????????????????,???????????????????
????????????Campbell???,????????GMP????????????,???GMP???????????????????GMP?????????????,??????;??????????????FDA????????«??????»,????????????FDA????GMP?????????????,“????????GMP???,??????????FDA??????????????”,Campbell?????????,?????????,“?????????????????????????,??????????,?????GMP?????FDA???” ???Campbell????????????,??????????????????????????,????????????,“????????GMP????????”?????????????GMP????????,?????????
2011?9?16?,FDA?????????????????????????????????????GMP????????????????????!