浅谈GLP实验室仪器设备SOP的制定

:,,;Tel:[phone]GLPSOP,1,2(,510520;1;2):GLP(SOP)SOP,SOP,SOPSOP,,SOP:;;;;:R926;R95417:A:100227777(2010)0220144203DiscussiononEstablishmentofSOPforInstrumentsandEquipmentinGLPLaboratoryYuZhiying,ZhuQing1andWangYan2(GuangdongFoodandDrugVocationalCollege,Guangzhou510520;1GuangzhouInstituteofPharmaceuticalIndustry;2GuangdongFoodandDrugVocationalTechnicalSchool)ABSTRACT:ObjectiveItwasareferenceforGLPlaboratorytodevelopstandardoperatingprocedures(SOP)ofinstrumentsandequipment.MethodsThroughpresentingcompilationmethodofspecificissuesofinstrumentsandequipmentSOP,andputtingforwardtheformulationofSOPprocedurestoimproveequipmentSOP’spracticalityandmaneuverability.ResultsandConclusionSOPisaprerequisiteforprocesscontrolandisthebasisofqualitysystemassurance.ThisarticledescribesthepointofviewnotonlyforthesafetyevaluationagenciestoapplybutalsoforotherareastodevelopSOP.KEYWORDS:instrumentsandequipment;SOP;flowdiagram;GLP;proceduraldocumentGLP(SOP)[1]OECDGLPSOP,[2]GLPSOP[324],,,SOP,1SOPGLPSOP,SOPSOP,SOP,GLP:FDAGLPSOP,,[5],SOP,[6]2SOP4412010242,SOP;,SOPSOP,,QASOP,,,SOP,,3SOPSOP,SPO,[7]SOP,,OECDGLP:SOP[2]1[8]1()(SOP)???()()()()SOP,,()SOP,,SOP,SOP,SOP4SOP,,,,,,,11SOP,,SOP,,,,2,,1,SOP22:,,SIPOC(supplier2input2process2output2customer)()SIPOC[9],,,13,,SIPOC,,,,7,,54120102423SIPOC:5,SOP,QA,SOP,SOPSOP,SOP,SOPGLPSOP,SOP,SOP,SOP2[10]SOP,SOP,,SOP,,,SOP:[1][S]114,20031[2]OECD1SeriesonPrinciplesofGoodLaboratoryPracticeandComplianceMonitoringNumber11OECDPrinciplesofGoodLaboratoryPractice1OrganisationforEconomicCo2operationandDevelopment[S]1ENV/MC/CHEM(98)17,19981[3]1GLP[J]1,2003,12(5):32123211[4],,,1GLPSOP[J].,2007,21(9):68926911[5]GoodLaboratoryPracticeforNonclinicalLaboratoryStudies(asrevisedinApril2005)[S].Title21FederalCodeofRegulationsPart58,20051[6],1GLP[J].,2007,21(4):28522861[7]InternationalConferenceonHarmonisationGuidelineonGoodClini2calPractice[S].19961[8]MichelleRosa,IrinaColligon1GLPSOPsforEquipmentCal2ibrationandMaintenance1Part2:AnOrganizedApproachtoStreamliningProceduralDocumentation[J]1TheQualityAssuranceJournal,2003,10(3):20322071[9],16Sigma[J]1(),2006,(3):502531[10]1GMP[J]1,2007,(6):432461(137)151026,21026,:[1][S]1,2005:452451[2],1[J]1,2005,20(6):52525261[3]16[J]1,2007,20(4):14421451[4],1[J]1,2004,5(6):102121[5],,,1[J]1(),1982,(4):312321[6],,1100[J]1,2001,18(2):432441[7]1[J]1,2002,19(1):522531[8],,,1[J]1,2007,18(11):2859228601[9]1[J]1,2006,7(2):482491[10],,1[J]1,2003,16(1):3023116412010242