??????cGMP????????????FDA QSR??(21 CFR Part
820),?????????????????,???????????????????????QSR/cGMP????????cGMP/QSR??
????????,???????????????????????????????????????????QSR/cGMP???QSR/cGMP?
??QSR/cGMP????
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????QSR/cGMP?????????:
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·????QSR/cGMP??
·??QSR/cGMP??
·???????
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?????????:
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·????
·?????
·??????
·GMP?SOP??
·???????
·????
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?????????:
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·????????
·?????????????
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????????????:
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·??????
·?????
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????????????:
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·????
·????
·????SOP
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????????????QSR/cGMP????:
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·??????QSR/cGMP??
·??????
·??????
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?????????:
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·??????
·??????
·???????
·????????
·????
·????
·??????
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?????????:
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·??????
·??????
·??????
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???????(CAPA)?????:
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·????????????
·?????????????
·?????????????
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????
-
????FDA????????(PAI)
-
????FDA???????
-
????FDA?????(FDA-483)
-
????FDA????
????
????
? ?????“????”??,?????????
