Q4B Regulatory Acceptance of Analytical Procedures and or Acceptance Criteria.pdf

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1、INTERNATIONALCONFERENCEONHARMONISATIONOFTECHNICALREQUIREMENTSFORREGISTRATIONOFPHARMACEUTICALSFORHUMANUSEDRAFTCONSENSUSGUIDELINEREGULATORYACCEPTANCEOFANALYTICALPROCEDURESAND/ORACCEPTANCECRITERIA(RAAPAC)Q4BCurrentStep2versiondated8June2006AtStep2oftheICHProcess,aconsensusdrafttextorguideline,ag

2、reedbytheappropriateICHExpertWorkingGroup,istransmittedbytheICHSteeringCommitteetotheregulatoryauthoritiesofthethreeICHregions(theEuropeanUnion,JapanandtheUSA)forinternalandexternalconsultation,accordingtonationalorregionalprocedures.Q4BDocumentHistoryCurrentStep2versionNewFirstCodificationHi

3、storyDateCodificationNovember2005Q4BApprovalbytheSteeringCommitteeunderStep28JuneQ4Bandreleaseforpublicconsultation.2006REGULATORYACCEPTANCEOFANALYTICALPROCEDURESAND/ORACCEPTANCECRITERIA(RAAPAC)DraftICHConsensusGuidelineReleasedforConsultationon8June2006,atStep2oftheICHProcessTABLEOFCONTENTS1

4、.INTRODUCTION..........................................................................................11.1Objective(s)oftheGuideline...........................................................................11.2Background.......................................................................

5、...............................11.3ScopeoftheGuideline.....................................................................................11.4GeneralPrinciples...........................................................................................22.GUIDELINES.............................

6、....................................................................22.1Q4BEvaluationProcess..................................................................................22.1.1Step1...................................................................................................22.1.2Ste

7、p2...................................................................................................22.1.3Step3...................................................................................................22.1.4Step4....................