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1、STANDARDOPERATINGPROCEDURE题目：对照品的接收、确认、贮存、分发和使用TitleRECEIPT,QUALIFICATION,STORAGE,DISTRIBUTIONANDUSEOFREFERENCESTANDARDS起草/修订人：日期：AuthorDate部门主管审查：日期：Dept.HeadApprovalDateQA批准：日期：ApprovedbyQADate分发：QA,QC,R&DDistribution:目的：描述化验室对照品的接收、确认、贮存、库存、分发、使用的规程。PURPOSE:Thisprocedur
2、edescribesaprocessusedbyLaboperationforthereceipt,qualification,storage,inventory,distributionanduseofanalyticalreferencestandard范围：适用于化验室内所用的对照品，包括基准对照品、第二对照品。SCOPE:ThisprocedureisapplicabletoanalyticalreferencestandardsusedinQClab,includesthePrimaryReferenceStandardsandt
3、heSecondaryReferenceStandards参考文件：REFERENCEANDATTACHMENT:SOP/题目SOP/TITLE记录/附件/题目FORMS/ATTACHMENTS/TITLE3-0002OOS调查附件1：对照品标签样例InvestigationofOut-of-SpecificationAttachment1:ReferenceStandardLabelResult(Example)F-03-010对照品登记台帐ReferenceStandardInventoryLogSheetF-03-011对照品接收记录
4、ReferenceStandardReceivingLogbookF-03-012对照品使用记录UseRecordofReferenceStandard定义：DEFINITIONS:基准对照品以广泛分析表明具有可信的、高纯度的物质。这类标准品可以：1）来源于法定机构；2）独立合成；3）来自于高纯度的现有生产物料；4）用进一步精制现有生产物料的方法来制备。ReferenceAsubstancethathasbeenshownbyanextensivesetofanalyticalteststobeStandard,authenticmater
5、ialthatshouldbeofhighpurity.Thisstandardcouldbe:(1)obtainedPrimaryfromanofficiallyrecognizedsource,(2)preparedbyindependentsynthesis,(3)obtainedfromexistingproductionmaterialofhighpurity,or(4)preparedbyfurtherpurificationofexistingproductionmaterial.第二对照品与基准对照品比较显示有规定的质量和纯
6、度，并用作日常检验分析的参考标准品。ReferenceAsubstanceofestablishedqualityandpurity,asshownbycomparisontoaprimaryStandard,referencestandard,usedasareferencestandardforroutinelaboratoryanalysis.SecondarySTANDARDOPERATINGPROCEDURE题目：对照品的接收、确认、贮存、分发和使用TitleRECEIPT,QUALIFICATION,STORAGE,DISTRI
7、BUTIONANDUSEOFREFERENCESTANDARDS规程：PROCEDURE:责任人操作RESPONSIBILITYACTION1.对照品接收RECEIPTOFREFERENCESTANDARDQC主管1.1QC主管指定专人负责对照品的管理；对照品管理员负责对照品的接收、贮存以及发放等的管理。QCQCSupervisordesigneeisresponsibleforthemanagementofallreferenceSupervisorstandards,suchasthereceipt,storageanddistribu
8、tionofreferencestandard.对照品管理员1.2接收对照品时，应检查对照品的包装是否完好、是否提供检验报告书、检验报告书是否与实物相符，等等。ControlCl
