化验室对照品规程

SSTTAANNDDAARRDDOOPPEERRAATTIINNGGPPRROOCCEEDDUURREE题目：Title对照品的接收、确认、贮存、分发和使用RECEIPT,QUALIFICATION,STORAGE,DISTRIBUTIONANDUSEOFREFERENCESTANDARDS起草/修订人：Author日期：Date部门主管审查：Dept.HeadApproval日期：DateQA批准：ApprovedbyQA日期：Date分发：Distribution:QA,QC,R&D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:ThisproceduredescribesaprocessusedbyLaboperationforthereceipt,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,includesthePrimaryReferenceStandardsandtheSecondaryReferenceStandards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-SpecificationResultAttachment1:ReferenceStandardLabel(Example)F-03-010对照品登记台帐ReferenceStandardInventoryLogSheetF-03-011对照品接收记录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。ReferenceStandard,PrimaryAsubstancethathasbeenshownbyanextensivesetofanalyticalteststobeauthenticmaterialthatshouldbeofhighpurity.Thisstandardcouldbe:(1)obtainedfromanofficiallyrecognizedsource,(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度，并用作日常检验分析的参考标准品。ReferenceStandard,SecondaryAsubstanceofestablishedqualityandpurity,asshownbycomparisontoaprimaryreferencestandard,usedasareferencestandardforroutinelaboratoryanalysis.SSTTAANNDDAARRDDOOPPEERRAATTIINNGGPPRROOCCEEDDUURREE题目：Title对照品的接收、确认、贮存、分发和使用RECEIPT,QUALIFICATION,STORAGE,DISTRIBUTIONANDUSEOFREFERENCESTANDARDS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。QCSupervisorQCSupervisordesigneeisresponsibleforthemanagementofallreferencestandards,suchasthereceipt,storageanddistributionofreferencestandard.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。ControlClerkUponreceipt,verifythepackageofthereferencestandards,confirmwhetherthecertificateofanalysisisavailable,andthereferencestandardsreceivedarethesameasthecertificateofanalysis,etc.1.3将对照品的相关信息在对照品登记台帐上作好记录，每批对照品建立一份管理台帐。EnterreferencestandardinformationintotheReferenceStandardReceivinglogbook,andestablishaReferenceStandardInventorylogsheetforeachlot.1.4接收后的对照品给定公司内批号。Assignthelotnumberforreceivedreferencestandards1.4.1对照品的批号由：类别号＋年号＋流水号组成：Thelotnumberisconsistof:Sortnumber+digitnumberofthecalendarYear+sequentialnumber:1.4.1.1类别号：Sortnumber1.4.1.1.1基准对照品：RSP（ReferenceStandard,Primary）1.4.1.1.2第二对照品：RSS（ReferenceStandard,Secondary）1.4.1.2年号：用2位数的年份表示Year:2digitnumberoftheyeardesignation.1.4.1.3流水号：用2位数字表示。Sequentialnumber:2digitnumber.1.5对照品接收后，在每批对照品的每个包装上贴签（附件1），标明名称、批号、数量、来源、瓶号/总瓶数（比如，共有10瓶，其中第2瓶为：2/10）、接收人签名/日期等内容。Attimeofreceipt,labeleachstandardcontainer(attachment1),withthereferencestandardname,lotnumber,quantity,source,containernumber/totalcontainersnumber(e.g.,thetotalcontaineris10bottles,thensecondbottleis2/10),andinitialanddateofthereceiver.SSTTAANNDDAARRDDOOPPEERRAATTIINNGGPPRROOCCEEDDUURREE题目：Title对照品的接收、确认、贮存、分发和使用RECEIPT,QUALIFICATION,STORAGE,DISTRIBUTIONANDUSEOFREFERENCESTANDARDS责任人操作RESPONSIBILITYACTION对照品管理员1.6将对照品放入标有“待确认对照品”的干燥器中，存放于2～8℃冰箱中，或者存放于对照品所规定的贮存条件。ControlClerkPlacereferencestandardintodesiccator(markedwith“ReferenceStandard,tobequalified”)inrefrigerator(temperaturecontrolledwithin2to8DegreeC),orplaceinrequiredstorageconditioninaccordancewithreferencestandard.1.7对照品应存放于棕色玻璃瓶中，对于不符合此要求的，在接收后，将对照品装入或分装于棕色玻璃瓶中。Thereferencestandardshouldbestoredinbrownglassbottles.Ifitisfoundnotmeetingtherequirement,itshouldbeplacedintoorsubdividedintobrownglassbottlesafterreceipt.2.对照品确认QUALIFICAITONOFREFERENCESTANDARDSQC2.1对照品应从法定机构购买（如，USP、EP、CP等）；并且，只要是适用的，内部使用的对照品应根据这些从法定机构购买来的对照品进行确认。如果法定对照品不能得到，则内部使用的对照品必须根据一个确认的标准品进行确认，或必须根据本SOP中下面的要求的进行全部的确认。Referencestandardsshouldbepurchasedfromanofficiallyrecognizedsource(e.g.,USP,EP,andCP)andin-housereferencestandardsshouldbequalifiedagainstthem,wheneverapplicable.Ifofficiallyreferencestandardisnotavailableorapplicable,in-housereferencestandardsmustbequalifiedagainstaqualifiedstandardorfullqualificationmustbeperformedaccordingtothefollowingrequirementofthisSOP.2.2对照品的确认包括：Thequalificationofreferencestandardincludes:2.2.1基准对照品的确认QualificationofPrimaryReferenceStandard2.2.2第二对照品的确认QualificationofSecondaryReferenceStandards2.2.2.1根据法定对照品（如，USP、EP、CP等）或其他已确认的标准，对内部使用的对照品的确认。Qualificationofin-housereferencestandardsagainstanofficialreferencestandard(e.g.,USP,EP,CP,etc.)orotherqualifiedstandard.2.2.2.2当没有法定对照品（如，USP、EP、CP等），或其他已确认的对照品时，内部使用的对照品的确认。Qualificationofanin-housereferencestandardwhenofficialreferencestandard(e.g.,USP,EP,CP,etc.),orotherqualifiedstandardisnotavailable.SSTTAANNDDAARRDDOOPPEERRAATTIINNGGPPRROOCCEEDDUURREE题目：Title对照品的接收、确认、贮存、分发和使用RECEIPT,QUALIFICATION,STORAGE,DISTRIBUTIONANDUSEOFREFERENCESTANDARDS责任人操作RESPONSIBILITYACTIONQC,QA2