??FDA?1987??????????????????,???????????CDRH???????,??????????????????,???????????????????????????21??????????????????????????????,??????????????????,FDA?2008?11?????????????????,????FDA??????????????????????????????2011?1?24?FDA???????????????,?«??????:??????? (Process Validation: General Principles and Practices)»?
????????????????????????????,????????FDA?????????GMP?????????????????????????????????????,?:
????????????2004?1?GHTF?????????,FDA???????????GHTF????????????
???????GMP?????,??????????????????????,????????????????GMP????????,???????????????????????????FDA??????????????GMP??????,?????????????????????,?????????????????
?2011?FDA??????,????????????,????????: