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1、(FDA)(CDER)2006.101.2.3.—:A.B.4.—:A.B.C.5.A.B./?C.FDA.FDA,FDA,,.1.FDA,OOSDMF,.CDER.(release).CGMP(21CFRparts210and211)(section501(a)(2)(B))./.OOS2002821CGMP,,.(PAT),,.PAT,.,CGMPPAT--.FDA,,.,,,.FDAshould,.2.(§§211.160and211.165)CGMP211I()J().cGMP211.165f,(APIs)CGMP501(a)(2)(B).API
2、sCGMP,,,OOS.211,FDAAPIsCGMP,OOS.FDAQ7AAPIsGMP(ICHQ7A)..3.—:FDAOOS,OOSOOS.OOS.,()(Forcontractlaboratories)?,,,OOS.A.CGMP211.160b(4).,,B.OOS..,1.2.3.4.5.6..7.OOS...�.�OOS�OOS.,,..CGMP,OOSOOS4.—:OOSOOSOOS.QCUOOS.OOS12345OOSOOSOOS,(§211.192)OOSB.OOSOOSCGMP(§211.160).FDAOOSCGMPsSOP§21
3、1.160(a)SOP§211.160(a)QCU,(III)OOSOOS(§211.160(b)(3)).,QCU(§§211.160211.165(c))C.121OOSa.USP(replicates译?)HPLC23,§211.160(b)(4)OOSOOSb.OOSOOS，。QCUQCU(§211.22)90%~110%OOS89%90%91%90%OOSOOS80%85%105%90%OOS2.CGMP(§211.165(d))SOPsSOPsSOPsUSPDesignandAnalysisofBiologicalAssays<111>USP
4、…(USP<111>)OOSOOSQCUV.QCUSOPA.QCUOOSOOS(§211.165)OOSOOSOOSOOSOOS§211.165(f),—1OOS2OOS—OOSOOSOOSQCU90.0%~110.0%OOS89.5%99.0%,98.9%,99.0%,99.1%,98.8%,99.1%,99.0%7QCUOOSOOSOOSOOSOOSQCUB.OOSOOSOOSUSPGeneralNoticesUSPGeneralNotices100%OOS(§211.194)C.3(21CFR314.81(b)(1)(ii))OOS"informa
5、tionconcerninganyfailure”OOS3FAROOSFAR
