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.制定人Preparedby审核人Reviewedby批准人Approvedby签名/日期Sign/Date名字Name职务Designation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,USEANDMAINTENANCEOFPHARMACOPOIEALREFERENCESTANDARD5.1.2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:www.usp.org-EP对照品ForEPCRS:www.pheur.org-BP对照品ForBPCRS:www.bpclab.co.uk-Ch.P对照品ForCh.PRS:http://www.nicpbp.org.cn/5.1.3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...
