??FDA???????«??????:???????»

??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??????,????????????,????????:

• ????? (Contract Manufacturing)
• ???? (Control of Components)
• ?????API???? (Importation of Active Pharmaceutical Ingredients(API) for Use in Human Drugs)
• ?????ß?????? (Non-Penicillin Beta-Lactam Contamination)
• ????????????:????????????????? (Heparin for Drug and Medical Device Use: Testing for Oversulfated Chondroitin Sulfate Contamination in Crude Heparin)