Q7_Guideline

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1、INTERNATIONALCONFERENCEONHARMONISATIONOFTECHNICALREQUIREMENTSFORREGISTRATIONOFPHARMACEUTICALSFORHUMANUSEICHHARMONISEDTRIPARTITEGUIDELINEGOODMANUFACTURINGPRACTICEGUIDEFORACTIVEPHARMACEUTICALINGREDIENTSQ7CurrentStep4versiondated10November2000ThisGuidelinehasbeen

2、developedbytheappropriateICHExpertWorkingGroupandhasbeensubjecttoconsultationbytheregulatoryparties,inaccordancewiththeICHProcess.AtStep4oftheProcessthefinaldraftisrecommendedforadoptiontotheregulatorybodiesoftheEuropeanUnion,JapanandUSA.Q7DocumentHistoryNewFi

3、rstCodificationHistoryDateCodificationNovember2005Q7AApprovalbytheSteeringCommitteeunderStep2and19Q7releaseforpublicconsultation.July2000CurrentStep4versionQ7AApprovalbytheSteeringCommitteeunderStep4and10Q7recommendationforadoptiontothethreeICHregulatoryNovemb

4、erbodies.2000GOODMANUFACTURINGPRACTICEGUIDEFORACTIVEPHARMACEUTICALINGREDIENTSICHHarmonisedTripartiteGuidelineHavingreachedStep4oftheICHProcessattheICHSteeringCommitteemeetingon10November2000,thisguidelineisrecommendedforadoptiontothethreeregulatorypartiestoICH

5、TABLEOFCONTENTS1.INTRODUCTION..............................................................................................................11.1Objective............................................................................................................

6、....11.2RegulatoryApplicability.......................................................................................11.3Scope......................................................................................................................12.QUALITYMANAG

7、EMENT.............................................................................................42.1Principles...............................................................................................................42.2ResponsibilitiesoftheQualityUnit(

8、s).................................................................42.3ResponsibilityforProductionActivities...............................................................52.4Inter