CGMP文件 药典对照品的接收、储存、使用和保管程序SOP

制定人Preparedby审核人Reviewedby批准人Approvedby签名/日期Sign/Date名字Name职务Designation标准操作程序StandardOperatingProcedure文件编码Doc.No.:颁发日期：IssueDate:生效日期：EffectiveDate:替代：Supersedes:复审日期ReviewDate:页码：第1页共4页PageNo.:1of4标题：药典对照品的接收、储存、使用和保管程序TITLE:PROCEDUREFORRECEIPT,STORAGE,USEANDMAINTENANCEOFPHARMACOPOIEALREFERENCESTANDARD1.0目的Purpose:规定药典对照品的接收、储存、使用和保管程序。Tolaydownaprocedureforreceipt,storage,useandmaintenanceofpharmacopoiealreferencestandard.2.0范围Scope:本SOP适用于QC实验室从药典部门（USP/BP/EDQM/NICPBP）接收的所有对照品。ThisSOPappliestoallreferencestandardsusedintheQClaboratory,whicharereceivedfrompharmacopoiealagencies(USP/BP/EDQM/NICPBP).3.0定义Definitions:USP：美国药典UnitedStatesPharmacopoeiaBP:英国药典BritishPharmacopoeiaEDQM：欧洲药品质量理事会EuropeanDirectoratefortheQualityofMedicinesNICPBP：中国药品生物制品检定所NationalInstitutefortheControlofPharmaceuticalandBiologicalProducts4.0责任Responsibility:QC检验员/组长/经理助理/经理QCanalysts/GroupLeader/AssistantManager/Manager5.0程序Procedure:5.1接收和储存Receiptandstorage5.1.1对照品应从药典部门或其授权代理机构购买。Referencestandardsshouldbeprocuredfrompharmacopoiealagencyorbytheirauthorizedagent.文件编码Doc.No.:Page2of4标题：药典对照品的接收、储存、使用和保管程序TITLE:PROCEDUREFORRECEIPT,STORAGE,USEANDMAINTENANCEOFPHARMACOPOIEALREFERENCESTANDARD制定人Preparedby审核人Reviewedby批准人Approvedby签名/日期Sign/Date名字Name职务Designation5.1.2接收对照品时应从下列网站下载最新的对照品目录并检查是否现行批号。Onreceiptofreferencestandards,checkwhetherthelotiscurrentornotfromthelatestcatalogsdownloadedfromfollowingwebsites:-USP对照品ForUSPRS:对照品ForBPCRS:://检查瓶子包装应完好无损，标签正确无误。Thevialshouldbecheckedforintactnessandcorrectnessoflabel.5.1.4接收情况应在附件-I中所示的《对照品接收记录》中记录Thereceiptshouldberecordedinthe‘ReferenceStandardsReceiptRecord’asperAnnexure-I.5.1.5对照品序号应作为内部编码并用以使用情况追溯。TheserialnumbershouldbetreatedasIn-houseidentificationnumberandshouldbeusedforreferencepurpose.5.1.6任何相关资料、包装的完好无损、现行批号状况和有效期（如果有）应记录在备注栏中。Receiptofanyliterature,intactnessofvial,currentlotstatusandexpirydate(Ifapplicable)shouldberecordedintheremarkcolumn.5.1.7所有对照品应按药典机构在标签上或个别文件中描述的储存条件进行储存。Allreferencestandardsshouldbestoredatstorageconditionsasprescribedbythepharmacopoiealagencyonthelabelorinrespectivedocuments.5.1.8如果接收的同一种对照品不止一瓶，则只能发放一瓶在使用记录中登记并使用（如附件-II所示）。Ifmorethanonevialofthesamereferencestandardisreceived,onlyonevialandusagerecord(AsperAnnexure-II)shouldbeissuedforuse.5.1.9同种对照品的剩余瓶数应储存并收藏起来，前一瓶使用完后，接着再发放下一瓶，并在如附件-II所示的《对照品使用记录》中登记。Remainingvialsshouldbemaintainedasstockandafterconsumptionofpreviousvial,nextvialofsamereferencestandardand‘referencestandardusagerecord’asperAnnexure-IIcouldbeissuedforuse.5.2对照品的使用Useofreferencestandards文件编码Doc.No.:Page3of4标题：药典对照品的接收、储存、使用和保管程序TITLE:PROCEDUREFORRECEIPT,STORAGE,USEANDMAINTENANCEOFPHARMACOPOIEALREFERENCESTANDARD制定人Preparedby审核人Reviewedby批准人Approvedby签名/日期Sign/Date名字Name职务Designation5.2.1确保对照品批号是现行有效的批号，并且瓶中无异常情况。Ensurethereferencestandardisofcurrentlotandthereisnoabnormalityinthevial.5.2.2使用对照品应注意避免所有污染和溢出。Takeallnecessaryprecautionstoavoidanycontaminationandspillageduringusingthereferencestandards.5.2.3打开瓶子前确保放置区域清洁且无以前样品的残留。Ensuretheareaiscleanandfreefromtracesofpreviousproductsbeforeopeningthevial.5.2.4冰箱储存的对照品使用前应放在干燥器中升到室温。Refrigeratedvialsshouldbeallowedtoequilibratetoroomtemperaturebykeepingthemindesiccatorsbeforeuse.5.2.5打开瓶子，只取出要求数量的对照品，取出的剩余对照品应丢弃，不得倒回瓶中。Openthevialandtakeonlyrequiredquantityofmaterial,remainingremovedmaterialshouldbediscardedandshouldnotpourbacktothevial.5.2.6使用完毕立即盖紧瓶盖并在瓶颈周围绕上封口膜。Immediatelyafteruse,closethevialwithoriginalcapandwrapPara-filmaroundtheneckofthevial.5.2.7分别按各自储存条件储存对照品。Storethevialtorespectivestoragecondition.5.2.8在附件-II所示的《对照品使用记录》中登记。Anentryfortheusageshouldbemadeinthe‘ReferenceStandardUsageRecord’asperAnnexure-II.5.3对照品的保管Maintenanceofreferencestandards5.3.1应对照现行对照品目录检查现有对照品。（参照“5.1接收和储存”中下载的现行对照品目录）。Currentlotofreferencestandardsshouldbecheckedagainstcurrentcatalogs.(Refer‘5.1Receiptandstorage’fordownloadingthecurrentcatalogs).5.3.2每月的第一周应检查对照品的储存情况，所有失效或用完的瓶子应从储存处移除并销毁。文件编码Doc.No.:Page4of4标题：药典对照品的接收、储存、使用和保管程序TITLE:PROCEDUREFORRECEIPT,STORAGE,USEANDMAINTENANCEOFPHARMACOPOIEALREFERENCESTANDARD制定人Preparedby审核人Reviewedby批准人Approvedby签名/日期Sign/Date名字Name职务DesignationFirstweekofeverymonth,stockofreferencestandardsshouldbereviewedandanyexpired/exhaustedvialshouldberemovedfromthestockandshouldbedestroyed.5.3.3应按附件-II所示的《对照品使用记录》中记录销毁情况。Entryfordestructionshouldbemadein‘ReferenceStandardUsageRecord’asperAnnexure-II.6.0相关文件RelatedDocuments:6.1对照品接收记录（附表-I）REFERENCESTANDARDSRECEIPTRECORD(Annexure-I)6.2对照品使用记录（附表-II）REFERENCESTANDARDUSAGERECORD(Annexure-II)7.0修订记录RevisionRecord:序号Sl.No版本号RevisionStatus修订内容DetailsofRevision备注Remarks******文件终结符ENDOFDOCUMENT制定人Preparedby审核人Reviewedby批准人Approvedby签名/日期Sign/Date名字Name职务Designation附表-IANNEXURE-I对照品接收记录REFERENCESTANDARDSRECEIPTRECORD参照文件编码Doc.Ref.No.:表格号FormNo.:生效日期EffectiveDate:第1页共1页page1of1序号S.No.接收日期DateofReceipt对照品名称ReferenceStandardName对照品来源Source批号LotNo.储存条件StorageCondition接收数量QuantityReceived接收人Receivedby备注Remark制定人Preparedby审核人Reviewedby