《Q2（R2）：分析方法验证》英文版.docx

rcHJharmonisationforbetterhealthINTERNATIONALCOUNCILFORHARMONISATIONOFTECHNICALREQUIREMENTSFORPHARMACEUTICALSFORHUMANUSEICHHARMONISEDGUIDELINEValidationofAnalyticalProceduresQ2(R2)FinalVersionAdoptedon1November2023ThGisuidhIAsoednevelboytpheae(j)prObCr值CiXagDrkGi11ogau.dhabseesnubjtoccotnsubUahrOgnuIpaatrotirElIeCSc,or“4i'hdeCHProcAefe4.pfthPeroCtehfsegndarlai廿IeCOmmfeOnaddeodpttofAnergeuIahtodroiyf(sHegicns.Q2(R2)DocumentHistoryCodeHistoryDateQ2ApprovalbytheSteeringCommitteeunderSte2andreleaseforpublicconsultation.26October1993Q2AApprovalbytheSteeringCommitteeunderSte4andrecommendationforadoptiontothethreeICHregulatorybodies.27October1994Q2BApprovalbytheSteeringCommitteeunderSte2andreleaseforpublicconsultation.29November1995Q2BApprovalbytheSteeringCommitteeunderSte4andrecommendationforadoptiontothethreeICHregulatorybodies.6November1996Q2(R1)TheparentguidelineisnowrenamedQ2(R1)astheguidelineQ2Bonmethodologyhasbeenincorporatedtotheparentguideline.Thenewtitleis44ValidationofAnalyticalProcedures:TextandMethodology”.November2005Q2(R2)CompleterevisionofguidelinetoincludemorerecentapplicationofanalyticalproceduresandtoaligncontentwithQl.4EndorsementbytheMembersoftheICHAssemblyunderSt>ndreleaseforpublicconsultation.24March2022Q2(R2)AdoptionbytheRegulatoryMembersoftheICHAssemblyunderStd.p1November2023Q2(R2)ErrorCorrectiontoTable5:DissolutionwithHPLCasproductperformancetestforanimmediatereleasedosageformReportableRangeLinearityformulaeonpage25;CorrectiontoTables6-11onpages26-32.30November20231.egalnotice:Thisdocumentisprotectedbycopyrightandmay,with,theexceptionoftheICHIogo,beused,reproduced,incorporatedintootherworks,adapted,modified,translatedordistributedunderapubliclicenseprovidedthatICH'scopyrightinthedocumentisacknowledgedatalltimes.Incaseofanyadaption,modificationortranslationofthedocument,reasonablestepsmustbetakentoclearlylabel,demarcateorotherwiseidentifythatchangesweremadetoorbasedontheoriginaldocument.Anyimpressionthattheadaption,modificationortranslationoftheoriginaldocumentisendorsedorsponsoredbytheICHmustbeavoided.Thedocumentisprovided"asis"withoutwarrantyofanykind.InnoeventshalltheICHortheauthorsoftheoriginaldocumentbeliableforanyclaim,damagesorotherliabilityarisingfromtheuseofthedocument.Theabove-mentionedpermissionsdonotapplytocontentsuppliedbythirdparties.Therefore,fordocumentswherethecopyrightvestsinathirdparty,permissionforreproductionmustbeObtainedfrofnthiscopyrightholder.ICHHarmonisedGuidelineValidationofAnalyticalProceduresQ2(R2)ICHConsensusGuidelineTableofContents1 INTRODUCTION11.1 Objective11.2 Scope12 GENERALCONSIDERATIONSFORANALYTICALPROCEDUREVALIDATION12.1 AnalyticalProcedureValidationStudy22.2 ValidationDuringtheLifecycleofanAnalyticalProcedure42.3 ReportableRange42.4 DemonstrationofStability-IndicatingProperties52.5 ConsiderationsforMultivariateAnalyticalProcedures53 VALIDATIONTESTS,METHODOLOGYANDEVALUATION73.1 SpecificityZSelectivity73. /GjeneCroanlsid73.1.1.1 AbsenceOfInterference73.1.1.2 OrthogonalProcedureComparison73.1.1.3 TechnologyInherentJustification73.1 R.2ecommDenad.t.ae.d.73.1.1.1 Identification73.1.1.2 Assay,PurityandImpurityTest(s)83.2 Range83.2G.leneCroanlside.81.1.2.1 3.2R.2esp.o.n.s.e91.1.2.2 1.inearResponse91.1.2.3 Non-linearResponse91.1.2.4 MultivariateCalibration103.2 .V3aIidoafLtoiwoRenarnLiem.i.,.t.s103.2.1.1 BasedonVisualEvaluation103.2.1.2 BasedonSignakto-Noise103.2.1.3 BasedontheStandardDeviationofaLinearResponseandaSlope103.2.1.4 BasedonAccuracyandPrecisionatLowerRangeLimits113.2.1.5 RecommendedData113.3 AccuracyandPrecision113.3A.Iccur.a.c.y.113.3.1.1 ReferenceMaterialComparison123.3.1.2 SpHdngStudy123.3.1.3 OrthogonalProcedureComparison123.3.1.4 RecommendedData123.3.1.5 P.2rec.i.s.i.o.n.123.3.2.1 Repeatability133.3.2.2 IntermediatePrecision133.3.2.3 Reproducibility133.3.2.4 RecommendedData133.3.2.5 C.3oinbAinpepdrofdOcArhcecsuarnaPdcyreci,.,s.i.o.n133.3.3.1RecommendedData133.4Robustness144 GLOSSARY145 REFERENCES186 ANNEX1:SELECTIONOFVALIDATIONTESTS197 ANNEX2:ILLUSTRATIVEEXAMPLESFORANALYTICALTECHNIQUES201 INTRODUCTION1.1 ObjectiveThisguidelinepresentselementsforconsiderationduringthevalidationofClrlaIytjCaIproce,cludcdeaspartofregistrationapplications.Analyticalprocedurevalidationformsapartoftheanalyticalprocedurelifecycle,asdescribedwithinICU14nalFtrioccaeIdureDevelo.Q2n(Rt2)providesguidanceonselectionandevaluationofthevariousvalldtae/IoiiVaonsaiyticalprocedures.Thisguidelineincludesacollectionoftermsandtheirdefinitions,whicharemeanttobridgethedifferencesthatoftenexistbetweenvariouscompendiaanddocumentsoftheICHmemberregulatoryauthorities.Theobjectiveofvalidationofananalyticalprocedureistodemonstratethattheanalyticalprocedureisfitfortheintendedpurpose.Furthergenera