????
????????????????????????????????,??:
????
???????????????????,???????CAPA?????????????????????????2??????,????????????????????????(CAPA)?????
????????,???????CAPA???????????FDA??????(Preamble)????? ???????????483?????cGMP?????,??????????FDA?CAPA???????(21 CFR Part 820 Quality System Regulation)???,????????????CAPA??????????????????,?????????????????????? ??????????????????????????????????(Situation Analysis)?????(Case Study),?????????????????,?????????,?????????????
????