Q2(R1)--Validation-of-Analytical-Procedures-Text-a

INTERNATIONALCONFERENCEONHARMONISATIONOFTECHNICALREQUIREMENTSFORREGISTRATIONOFPHARMACEUTICALSFORHUMANUSEICHHARMONISEDTRIPARTITEGUIDELINEVALIDATIONOFANALYTICALPROCEDURES:TEXTANDMETHODOLOGYQ2(R1)CurrentStep4versionParentGuidelinedated27October1994(ComplementaryGuidelineonMethodologydated6November1996incorporatedinNovember2005)ThisGuidelinehasbeendevelopedbytheappropriateICHExpertWorkingGroupandhasbeensubjecttoconsultationbytheregulatoryparties,inaccordancewiththeICHProcess.AtStep4oftheProcessthefinaldraftisrecommendedforadoptiontotheregulatorybodiesoftheEuropeanUnion,JapanandUSA.Q2(R1)DocumentHistoryFirstCodificationHistoryDateNewCodificationNovember2005ParentGuideline:TextonValidationofAnalyticalProceduresQ2ApprovalbytheSteeringCommitteeunderStep2andreleaseforpublicconsultation.26October1993Q2Q2AApprovalbytheSteeringCommitteeunderStep4andrecommendationforadoptiontothethreeICHregulatorybodies.27October1994Q2GuidelineonValidationofAnalyticalProcedures:MethodologydevelopedtocomplementtheParentGuidelineQ2BApprovalbytheSteeringCommitteeunderStep2andreleaseforpublicconsultation.29November1995inQ2(R1)Q2BApprovalbytheSteeringCommitteeunderStep4andrecommendationforadoptiontothethreeICHregulatorybodies.6November1996inQ2(R1)CurrentStep4versionQ2AandQ2BTheparentguidelineisnowrenamedQ2(R1)astheguidelineQ2Bonmethologyhasbeenincorporatedtotheparentguideline.Thenewtitleis“ValidationofAnalyticalProcedures:TextandMethodology”.November2005Q2(R1)VALIDATIONOFANALYTICALPROCEDURES:TEXTANDMETHODOLOGYICHHarmonisedTripartiteGuidelineTABLEOFCONTENTSPARTI:TEXTONVALIDATIONOFANALYTICALPROCEDURES..................................11.Introduction............................................................................................................12.TypesofAnalyticalProcedurestobeValidated...................................................1TABLE.............................................................................................................................3GLOSSARY.......................................................................................................................4PARTII:VALIDATIONOFANALYTICALPROCEDURES:METHODOLOGY..................6INTRODUCTION.............................................................................................................61.SPECIFICITY.........................................................................................................61.1.Identification.......................................................................................................71.2.AssayandImpurityTest(s)................................................................................72.LINEARITY.............................................................................................................83.RANGE.....................................................................................................................84.ACCURACY.............................................................................................................94.1.Assay...................................................................................................................94.2.Impurities(Quantitation)................................................................................104.3.RecommendedData..........................................................................................105.PRECISION..........................................................................................................105.1.Repeatability.....................................................................................................105.2.IntermediatePrecision.....................................................................................105.3.Reproducibility.................................................................................................105.4.RecommendedData..........................................................................................106.DETECTIONLIMIT............................................................................................116.1.BasedonVisualEvaluation.............................................................................116.2.BasedonSignal-to-Noise.................................................................................116.3BasedontheStandardDeviationoftheResponseandtheSlope.................116.4RecommendedData..........................................................................................11iValidationofAnalyticalProcedures:TextandMethodology7.QUANTITATIONLIMIT....................................................................................127.1.BasedonVisualEvaluation............................................................................127.2.BasedonSignal-to-NoiseApproach................................................................127.3.BasedontheStandardDeviationoftheResponseandtheSlope.................127.4RecommendedData.........................................................................................138.ROBUSTNESS