EDQM-分析方法验证

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1、PA/PH/OMCL(05)47DEF-OMCLGuidelineonValidationofAnalyticalProceduresOMCLNetworkoftheCouncilofEuropeQUALITYASSURANCEDOCUMENTPA/PH/OMCL(05)47DEFVALIDATIONOFANALYTICALPROCEDURESFulldocumenttitleandValidationofAnalyticalProceduresreferencePA/PH/OMCL(05)47DEFDocumenttypeGuidelin

2、eLegislativebasisThepresentdocumentwasalsoacceptedbyEAasrecommendationdocumenttobeusedinthecontextofQualityManagementSystemauditsofOMCLsDateoffirstadoptionOctober1999DateoforiginalentryFebruary2000intoforceDateofentryintoforceJune2005ofreviseddocumentPrevioustitles/otherTh

3、isdocumentreplacesdocumentPA/PH/OMCL(99)37DEFreferencesCustodianThepresentdocumentwaselaboratedbyOMCLOrganisationNetwork/EDQMoftheCouncilofEuropeConcernedNetworkGEONJune2005Page1of8PA/PH/OMCL(05)47DEF-OMCLGuidelineonValidationofAnalyticalProceduresVALIDATIONOFANALYTICALPRO

4、CEDURESGUIDELINEFOROMCLsINTRODUCTIONThetwoICHGuidelineson“ValidationofAnalyticalProcedures:“Definition/TerminologyandMethodology”(Q2AandQ2B)constituteadiscussionofthevalidationcharacteristicsthatshouldbeconsideredduringthevalidationofananalyticalprocedure(theguidelinehasal

5、sobeenadoptedforveterinaryproductsduringVICHdiscussion).Theyareprimarilyaddressedtopharmaceuticalindustryindicatingwhichvalidationdataneedtobeprovidedinanapplicationfile.Thesedatashoulddemonstratethattheproposedtestingandacceptancecriteriaaresufficientlyundercontroltoguara

6、nteereproduciblequalityoftheproductsatreleaseandadequatecontrolduringshelf-life(stability).AsthecircumstancesunderwhichanOMCLworksaredifferentfromthoseofapharmaceuticalcompany–inmostcasesnoroutineanalysis,butoftenresponsestobemadeinashortperiodoftime-,theextentofanalytical

7、validationrequestedbeforeperformingananalysisneedstobereconsidered.Ontheotherhandithasinallcasestobeguaranteedthattheresultsubmittedisreliable.Itshouldalsobeemphasisedhere,thatadequatereferencematerialsareanimportantfactorinboththeperformanceofthevalidationstudiesandtheana

8、lysisit-self.Theuseofwidelyacceptedreferencepreparationscanincertaincircumstancesavoidthe