????
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??GMP??????????
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??GMP??????
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??????(FDA)GMP????
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????(QA)??
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????????(QC)??
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??????
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??????
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??????
-
?????,???????
????
???????????????GMP????????,??????????????????????GMP?????????????????????EMEA/??FDA???GMP?????,?????????????????????????????
????
????????,????????????????????,?????????????
????
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??GMP???FDA cGMP?????
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??GMP??,??:??1?????
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?????(QP)???????
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QA/QC???GMP????
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ICH Q8(????)/Q9(??????)/Q10(??????)??
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PIC/S?????
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FDA?????
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21??FDA?????????????
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?????????
-
????
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???????(PAT)
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????/??(21CFR11)
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??????????????
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GMP???????????
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?????:?????????
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????????
-
???????
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???????:????????????????
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????
-
????????????
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????:??????
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???????
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????????????
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?????
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??????????(?????)?
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?????????:FDA?????????
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????????:??????????
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????:???????????
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??????
????
Dr.Per H.Damgaard
Dr.Damgaard????????????????????,?????????QC????????12
?;??????????,??QA????;??????????????(IRCA)????????(EEC)????????????
(APIC)???????