??????cGMP????????????FDA?cGMP??(21CFR Part 111?21 CFR Part
110????),?????????????????,?????????????????????????cGMP????????cGMP????
??????,?????????????????????????????????????
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·??GMP??
·???????
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·?????????
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·?????????
·???????
·?????
·????SOP
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????????????cGMP????:
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·??????cGMP??
·??????
·??????
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???????:
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·?????????????
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·????
·GMP?SOP??
·?????
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·????(OOS)??
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????
-
????FDA???????
-
????FDA?????(FDA-483)
-
????FDA????
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? ?????“????”??,?????????
