Q7a Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients .pdf

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1、INTERNATIONALCONFERENCEONHARMONISATIONOFTECHNICALREQUIREMENTSFORREGISTRATIONOFPHARMACEUTICALSFORHUMANUSEICHHARMONISEDTRIPARTITEGUIDELINEGOODMANUFACTURINGPRACTICEGUIDEFORACTIVEPHARMACEUTICALINGREDIENTSRecommendedforAdoptionatStep4oftheICHProcesson10November200

2、0bytheICHSteeringCommitteeThisGuidelinehasbeendevelopedbytheappropriateICHExpertWorkingGroupandhasbeensubjecttoconsultationbytheregulatoryparties,inaccordancewiththeICHProcess.AtStep4oftheProcessthefinaldraftisrecommendedforadoptiontotheregulatorybodiesoftheE

3、uropeanUnion,JapanandUSA.GOODMANUFACTURINGPRACTICEGUIDEFORACTIVEPHARMACEUTICALINGREDIENTSICHHarmonisedTripartiteGuidelineHavingreachedStep4oftheICHProcessattheICHSteeringCommitteemeetingon10November2000,thisguidelineisrecommendedforadoptiontothethreeregulator

4、ypartiestoICHTABLEOFCONTENTS1.INTRODUCTION.................................................................................................11.1Objective........................................................................................................11.

5、2RegulatoryApplicability..............................................................................11.3Scope.........................................................................................................12.QUALITYMANAGEMENT.......................

6、.........................................................42.1Principles........................................................................................................42.2ResponsibilitiesoftheQualityUnit(s).............................................

7、..........42.3ResponsibilityforProductionActivities....................................................52.4InternalAudits(SelfInspection).................................................................52.5ProductQualityReview.................................

8、..............................................63.PERSONNEL.........................................................................................................63.1PersonnelQualificati