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)47DEFDocumenttypeGu

2、idelineLegislativebasisThepresentdocumentwasalsoacceptedbyEAasrecommendationdocumenttobeusedinthecontextofQualityManagementSystemauditsofOMCLsDateoffirstadoptionOctober1999DateoforiginalentryFebruary2000intoforceDateofentryintoforceJune2005ofreviseddocumentPreviousti

3、tles/otherThisdocumentreplacesdocumentPA/PH/OMCL(99)37DEFreferencesCustodianThepresentdocumentwaselaboratedbyOMCLOrganisationNetwork/EDQMoftheCouncilofEuropeConcernedNetworkGEONJune2005Page1of8PA/PH/OMCL(05)47DEF-OMCLGuidelineonValidationofAnalyticalProceduresVALIDAT

4、IONOFANALYTICALPROCEDURESGUIDELINEFOROMCLsINTRODUCTIONThetwoICHGuidelineson“ValidationofAnalyticalProcedures:“Definition/TerminologyandMethodology”(Q2AandQ2B)constituteadiscussionofthevalidationcharacteristicsthatshouldbeconsideredduringthevalidationofananalyticalpro

5、cedure(theguidelinehasalsobeenadoptedforveterinaryproductsduringVICHdiscussion).Theyareprimarilyaddressedtopharmaceuticalindustryindicatingwhichvalidationdataneedtobeprovidedinanapplicationfile.Thesedatashoulddemonstratethattheproposedtestingandacceptancecriteriaares

6、ufficientlyundercontroltoguaranteereproduciblequalityoftheproductsatreleaseandadequatecontrolduringshelf-life(stability).AsthecircumstancesunderwhichanOMCLworksaredifferentfromthoseofapharmaceuticalcompany–inmostcasesnoroutineanalysis,butoftenresponsestobemadeinashor

7、tperiodoftime-,theextentofanalyticalvalidationrequestedbeforeperformingananalysisneedstobereconsidered.Ontheotherhandithasinallcasestobeguaranteedthattheresultsubmittedisreliable.Itshouldalsobeemphasisedhere,thatadequatereferencematerialsareanimportantfactorinboththe

8、performanceofthevalidationstudiesandtheanalysisit-self.Theuseofwidelyacceptedreferencepreparationscanincertaincircumstancesavoidthe