ICH 分析程序的验证方法学.pdf

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1、INTERNATIONALCONFERENCEONHARMONISATIONOFTECHNICALREQUIREMENTSFORREGISTRATIONOFPHARMACEUTICALSFORHUMANUSEICHHARMONISEDTRIPARTITEGUIDELINEVALIDATIONOFANALYTICALPROCEDURES:METHODOLOGYRecommendedforAdoptionatStep4oftheICHProcesson6November1996bytheICHSteeringCommitteeThisGuidel

2、inehasbeendevelopedbytheappropriateICHExpertWorkingGroupandhasbeensubjecttoconsultationbytheregulatoryparties,inaccordancewiththeICHProcess.AtStep4oftheProcessthefinaldraftisrecommendedforadoptiontotheregulatorybodiesoftheEuropeanUnion,JapanandUSA.VALIDATIONOFANALYTICALPROC

3、EDURES:METHODOLOGYICHHarmonisedTripartiteGuidelineHavingreachedStep4oftheICHProcessattheICHSteeringCommitteemeetingon6November1996,thisguidelineisrecommendedforadoptiontothethreeregulatorypartiestoICHNotertilA301side4.14.ICHmethodologyTABLEOFCONTENTSINTRODUCTION4.31SPECIFIC

4、ITY4.31.1Identification4.31.2AssayandImpurityTest(s)2LINEARITY4.43RANGE4.54ACCURACY4.54.1Assay4.54.2Impurities(Quantitation)4.64.3RecommendedData4.65PRECISION4.65.1Repeatability4.65.2IntermediatePrecision4.75.3Reproducibility4.75.4RecommendedData4.76DETECTIONLIMIT4.76.1Base

5、donVisualEvaluation4.76.2BasedonSignal-to-Noise4.76.3BasedontheStandardDeviationoftheResponseandtheSlope4.76.4RecommendedData4.87QUANTITATIONLIMIT4.87.1BasedonVisualEvaluation4.87.1BasedonSignal-to-NoiseApproach4.87.3BasedontheStandardDeviationoftheResponseandtheSlope4.87.4

6、RecommendedData4.98ROBUSTNESS4.99SYSTEMSUITABILITYTESTING4.10NotertilA301side4.24.ICHmethodologyVALIDATIONOFANALYTICALPROCEDURES:METHODOLOGYINTRODUCTIONThisdocumentiscomplementarytotheparentdocumentwhichpresentsadiscussionofthecharacteristicsthatshouldbeconsideredduringthev

7、alidationofanalyticalprocedures.Itspurposeistoprovidesomeguidanceandrecommendationsonhowtoconsiderthevariousvalidationcharacteristicsforeachanalyticalprocedure.Insomecases(forexample,demonstrationofspecificity),theoverallcapabilitiesofanumberofanalyticalproceduresincombinat

8、ionmaybeinvestigatedinordertoensurethequalityofthedrugsubstanceordrugproduct.Inadd