CGMP文件-工作对照品杂质对照品的接收处理保管标准程序SOP

制定人Preparedby审核人Reviewedby批准人Approvedby签名/日期Sign/Date名字Name职务Designation1.0目的Purpose:描述工作对照品/对照品/杂质对照品的接收、处理和保管的标准程序Tolaydownaprocedureforreceipt,handlingandmaintenanceofworkingstandard/referencestandardandimpurities.2.0范围Scope:本程序适用于工作对照品/对照品/杂质对照品的接收、处理和保管。这些对照品来自研发部门和外部原料药生产商。Thisprocedureisapplicableforreceipt,handlingandmaintenanceofworkingstandard/referencestandardandimpuritiesreceivedfromR&D&ExternalAPIvendor.3.0定义Definitions:无Nil4.0责任Responsibility:所有的QC人员有责任在他们的岗位上遵循此标准操作程序的操作。AllQCpersonalareresponsibleforfollowingthisSOPaspertheirrespectiveroles.5.0程序Procedure5.1接收Receipt:5.1.1在接收的时候，检查是否有检验报告单（COA）和支持性数据。若没有，则向厂家索取。检查容器是否完好无损，对比COA和标签的内容。Atthetimeofreceipt,checktheavailabilityofCertificateofAnalysis(COA)andsupportingdata.Ifnot,thenaskthesourcetoprovidethem.ChecktheintactnessofcontainersandcomparethecontentsofCOAandlabel.5.1.2如果发现不符合之处，跟生产商联系来更正它。Ifanydiscrepancyisobserved,thencontactsuppliertocorrectthem.5.1.3按照附录-I的要求记录每个工作对照品/对照品/杂质对照品的接收细节。Recordthereceiptdetailsofeachworkingstandard/referencestandardandimpuritiesasperAnnexure-I.5.1.4接收的序号应被视为工作对照品/对照品/杂质对照品的内部编码。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5页PageNo.:1of5标题：工作对照品/对照品/杂质对照品的接收、处理和保管标准程序TITLE:RECEIPT,HANDLINGANDMAINTENANCEOFWORKING/REFERENCEANDIMPURITYSTANDARDTheserialnumberofreceiptshouldbetreatedasIn-houseIDofworkingstandard/referencestandardandimpurities.5.1.5在COA上注明内部编码，把所有的COA按内部编码的顺序放在单独的文件夹里。MentionIn-houseIDontheCOAandkeepallCOAinaseparatefileasperIn-houseID.5.1.6关于原料药的工作对照品/对照品，检查一下COA和标签上是否折算过的含量。如果没有，用下面的公式，依据附录-II,计算折算后的含量。Forworking/referencestandardforAPI,checkifthepotencyon‘as-is-basis’isavailableonCOAandlabel.Ifnot,calculatethepotencyon‘as-is-basis’usingfollowingformulaasperAnnexure-II.5.2公式Formula:5.2.1如果含量是按无水物/干燥品计算Iftheassayisonanhydrous/driedbasis折算后的含量(%w/w)：Potencyof‘as-is-basis’(%w/w):按无水物/干燥品计算的含量(%w/w)×(100-KF水分%/干燥失重%)100Assayonanhydrous/driedbasis(%w/w)X(100-%WaterbyKF/LOD)1005.2.2如果含量是按无水物/干燥品和无溶剂物计算Iftheassayisonanhydrous/driedandsolventfreebasis折算后的含量Potencyof‘as-is-basis’(%w/w)：按无水物/干燥品计算的含量(%w/w)×(100-KF水分%/)×（100-溶剂%）100X100Assayonanhydrous/driedbasis(%w/w)X(100-%WaterbyKF/LOD)X(100-%Solvent)100X1005.2.3将附录-II附在接收的COA后。AttachAnnexure-IItotheCOAreceived5.2.4给小瓶贴上含有下面信息的中文标签。LabelthevialsinChineselanguagewithfollowingdetailsonthelabel:-产品名称NameofProduct-批号Batch/LotNumber-内部编码In-houseID-折算含量Potencyon‘as-is-basis’-生产日期ManufacturingDate-复测日期RetestDate-储存条件StorageCondition5.2.5每个接收的对照品依照附录-III做好“工作对照品/杂质对照品使用记录”。Issue‘Working/ImpurityStandardUsageRecord’asperAnnexure-IIIforeachitemreceived.5.2.6如果相同杂质/工作对照品多于一个小瓶，只能先使用一个。Ifmorethanonevialofsameimpurity/workingstandardisavailable,onlyonevialshouldbeissuedforuse.5.2.7剩余的小瓶应该作为库存，在前一个小瓶消耗完后，再分发使用。Remainingvialsshouldbemaintainedasstockandshouldbeissuedaftertheconsumptionofpreviousvial.5.3处理Handling5.3.1确保对照品是有效的，还没过期。Ensurethatthestandardisvalidandhasnotexpired.5.3.2冰箱中的小瓶存放在干燥器中，恢复到室温。Refrigeratedvialsshouldbebroughttoroomtemperaturebykeepingindesiccator.5.3.3在确定工作区域是干净的，并且没有前面的污染后，再打开工作对照品的小瓶。Opentheworkingstandardvialafterensuringthattheworkingareaiscleanandfreefrompreviouscontamination.5.3.4从小瓶中取出需要的数量，如果取出的数量过多，不要把多余的放回去，丢掉多余的。Removeonlyrequiredquantityfromthevial,ifexcessquantityisremoved,thendonotputitbacktovial,discardtheexcessmaterial.5.3.5使用完后，立刻盖紧瓶子，恢复各自的储存条件。Afteruse,immediatelyclosethevialandreturntotherespectivestoragecondition.5.3.6每个分发的小瓶按照附录-III记录分发情况。RecordthedetailsasperAnnexure-IIIissuedfortheparticularvial.5.4保管Maintenance5.4.1移走过期的小瓶。Removeexpiredvialsfromtheuse.5.4.2提前取得新对照品，取代过期的对照品。Procurenewstandardtoreplacetheexpiredstandardwellinadvance.6.0相关文件RelatedDocuments:6.1外来工作对照品/杂质对照品接收记录（附件-I）WORKING/IMPURITYSTANDARDSRECEIPTRECORD(ANNEXURE-I)6.2从外部接收的工作对照品的含量计算记录（附件-II）POTENCYCALCULATIONOFWORKINGSTANDARDRECEIVEDFROMOTHERLACATIONS(ANNEXURE-II)6.3外来工作对照品/杂质对照品使用记录（附件-III）WORKING/IMPURITYSTANDARDUSAGERECORD(ANNEXURE-III)7.0修订记录RevisionRecord:序号Sl.No版本号RevisionStatus修订内容DetailsofRevision备注Remarks******文件终止符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外来工作对照品/杂质对照品接收记录WORKING/IMPURITYSTANDARDSRECEIPTRECORD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品名Name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批准人Approvedby签名/日期Sign/Date名字Name职务Designation附件-IIANNEXURE-II从外部接收的工作对照品的含量计算记录POTENCYCALCULATIONOFWORKINGSTANDARDRECEIVEDFROMOTHERLACATIONS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从外部接收的工作对照品的含量计算记录POTENCYCALCULATIONOFWORKINGSTANDARDRECEIVEDFROMOTHERLACATIONS工作对照品名称NameofWorkingStandard:工作对照品批号B.No./LotNo.ofWorkingStandard:工作对照品内部编码In-houseIDofWorkingStandard:含量%，按无水物/干燥品计%w/wAssayonanhydrous/driedbasis:含量%，按无水物/干燥品和无溶剂物计%w/wAssayonanhydrous/driedandsolventfreebasis:水分%/干燥失重%%Watercontent/Lossondrying:残留溶剂含量%%solventcontents:折算后的含量Assay/Potencyonasisbasis:________________________________计算人（签名/日期）复核人