《Q2(R2):分析方法验证》英文版.docx
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1、rcHJharmonisationforbetterhealthINTERNATIONALCOUNCILFORHARMONISATIONOFTECHNICALREQUIREMENTSFORPHARMACEUTICALSFORHUMANUSEICHHARMONISEDGUIDELINEValidationofAnalyticalProceduresQ2(R2)FinalVersionAdoptedon1November2023ThGisuidhIAsoednevelboytpheae(j)prObCr值CiXagDrkGi11ogau.dhabseesnubjtoccotnsubUahrOgnu
2、IpaatrotirElIeCSc,or“4ihdeCHProcAefe4.pfthPeroCtehfsegndarlai廿IeCOmmfeOnaddeodpttofAnergeuIahtodroiyf(sHegicns.Q2(R2)DocumentHistoryCodeHistoryDateQ2ApprovalbytheSteeringCommitteeunderSte2andreleaseforpublicconsultation.26October1993Q2AApprovalbytheSteeringCommitteeunderSte4andrecommendationforadopt
3、iontothethreeICHregulatorybodies.27October1994Q2BApprovalbytheSteeringCommitteeunderSte2andreleaseforpublicconsultation.29November1995Q2BApprovalbytheSteeringCommitteeunderSte4andrecommendationforadoptiontothethreeICHregulatorybodies.6November1996Q2(R1)TheparentguidelineisnowrenamedQ2(R1)astheguidel
4、ineQ2Bonmethodologyhasbeenincorporatedtotheparentguideline.Thenewtitleis44ValidationofAnalyticalProcedures:TextandMethodology”.November2005Q2(R2)CompleterevisionofguidelinetoincludemorerecentapplicationofanalyticalproceduresandtoaligncontentwithQl.4EndorsementbytheMembersoftheICHAssemblyunderStndrel
5、easeforpublicconsultation.24March2022Q2(R2)AdoptionbytheRegulatoryMembersoftheICHAssemblyunderStd.p1November2023Q2(R2)ErrorCorrectiontoTable5:DissolutionwithHPLCasproductperformancetestforanimmediatereleasedosageformReportableRangeLinearityformulaeonpage25;CorrectiontoTables6-11onpages26-32.30Novemb
6、er20231.egalnotice:Thisdocumentisprotectedbycopyrightandmay,with,theexceptionoftheICHIogo,beused,reproduced,incorporatedintootherworks,adapted,modified,translatedordistributedunderapubliclicenseprovidedthatICHscopyrightinthedocumentisacknowledgedatalltimes.Incaseofanyadaption,modificationortranslati
7、onofthedocument,reasonablestepsmustbetakentoclearlylabel,demarcateorotherwiseidentifythatchangesweremadetoorbasedontheoriginaldocument.Anyimpressionthattheadaption,modificationortranslationoftheoriginaldocumentisendorsedorsponsoredbytheICHmustbeavoided.Thedocumentisprovidedasiswithoutwarrantyofanyki
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- Q2R2:分析方法验证 Q2 R2 分析 方法 验证 英文
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