包装批记录的签发与流转

GLAXOSMITHKLINEBIOLOGICALS(SHANGHAI)LTD上海葛兰素史克生物制品有限公司Doc.No.:VS001编号：STANDARDOPERATIONPROCEDURE标准操作程序VersionNo.:9.0版本号包装批记录的签发与流转BatchRecordissuingandcirculationSupersededDate:30/10/2010替代版本日期Page1of9页数EffectiveDate:生效日期SOPinuse该流程的执行人Thefollowingpersonisaccountablefortheprocessimplementationandoutput价值流经理ValueStreamManagerAnyprintedcopyofthisdocumentisnon-controlledunlessithastheblueQAControlledstampLastsaved保存时间03/08/201911:08AM总页数:11页(9页＋2个附件:2页)Totalpages:11pages(9pages+2appendicx:2pages)目录TABLEOFCONTENTS:1.目的OBJECTIVE......................................................................................................................22.范围SCOPE.............................................................................................................................23.职责RESPONSIBILITIES.........................................................................................................24.步骤PROCEDURE...................................................................................................................34.0流程图Flowchart..........................................................................................................34.1包装批记录的签发BatchRecordissuing.........................................................................44.2包装批记录的流转BatchRecordcirculation....................................................................64.3定期数据回顾PeriodicProcessReview..........................................................................85.术语GLOSSARY......................................................................................................................96.参考文件REFERENCES..........................................................................................................97.附件APPENDIX........................................................................................................................98.其他相关信息RELATEDFORMSANDTRAININGMATERIAL.................................................98.1表格Forms.....................................................................................................................98.2培训资料TrainingMaterial..............................................................................................9GLAXOSMITHKLINEBIOLOGICALS(SHANGHAI)LTD上海葛兰素史克生物制品有限公司Doc.No.:VS001编号：VersionNo.:9.0版本号Page2of9页数EffectiveDate:生效日期Anyprintedcopyofthisdocumentisnon-controlledunlessithastheblueQAControlledstampLastsaved保存时间03/08/201911:08AM1.目的OBJECTIVE描述开始生产操作前，包装批记录签发给生产部门的流程TodescribetheprocesstoissuebatchrecordtothePackagingDepartmentforstartingpackagingoperations.2.范围SCOPE在上海葛兰素史克生物制品的所有包装操作TheprocedureisapplicabletopackagingoperationsinGSKBS3.职责RESPONSIBILITIES价值流部门负责包装批记录的准备。QA负责包装批记录的批准。包装部门负责包装批记录的归档，直至批记录完成后交给质保部。价值流部门负责整个流程的追踪。VSCisresponsibleforpreparingthebatchrecord.QAisresponsibleforapprovingthebatchrecord.PackagingisresponsibleforarchivingtheapprovedbatchrecorduntilsubmittedtoQAwithfinalizedBR.VSCisaccountableforalltheprocess.GLAXOSMITHKLINEBIOLOGICALS(SHANGHAI)LTD上海葛兰素史克生物制品有限公司Doc.No.:VS001编号：VersionNo.:9.0版本号Page3of9页数EffectiveDate:生效日期Anyprintedcopyofthisdocumentisnon-controlledunlessithastheblueQAControlledstampLastsaved保存时间03/08/201911:08AM4.步骤PROCEDURE4.0流程图Flowchart在本SOP中InthisSOP在相关SOP中NotinthisSOP问题QuestionYes4.5定期数据回顾PeriodicProcessReview情况异常？Abnormality?参考QA053(风险管理)或QA028(异常事件及调查处理)RefertoQA053(RiskMgt)orQA028(Incident&Investigationmgt)包装批记录是否正确IfBatchRecordcorrect4.2包装批记录的流转BatchRecordcirculationNoYes4.1包装批记录的签发BatchRecordissuingGLAXOSMITHKLINEBIOLOGICALS(SHANGHAI)LTD上海葛兰素史克生物制品有限公司Doc.No.:VS001编号：VersionNo.:9.0版本号Page4of9页数EffectiveDate:生效日期Anyprintedcopyofthisdocumentisnon-controlledunlessithastheblueQAControlledstampLastsaved保存时间03/08/201911:08AM4.1包装批记录的签发BatchRecordissuing4.1.1介绍IntroductionN/A4.1.2详细步骤DetailedstepsID操作步骤（什么）Action(What)谁(职责）Who(func.)控制,指标,规则（QA,EHS,Fi…）Controls,KPIs,Rules(QA,EHS,Fi…)1.根据生产计划在半个工作日前签发包装批记录.IssueBRasperproductionplanningatlatesthalfofworkingdaybeforeoperation价值流协调VSC包装流水号编号原则如下：Numberprincipleofbatchrecordasfollow:包装流水号由七位阿拉伯数字组成，前四位阿拉伯数字代表年份，如:2009代表2009年度。后三位阿拉伯数字为流水号，从001开始。ThepacksequencenumberisArabicnumberwithsevendigits.ThefirstfourdigitsstandforYear,e.g.2009standfortheyearof2009.Thelastthreedigitsstandforthesequentnumberwhichbeginsfromnumber001.无论用于EPI包装，还是用于返工、拆批、生产中检所取样,目检，都用新的包装流水号编号。ThenewpacksequencenumbersareusedforEPIpackage,rework,unpack,NICPBPsamplingandvisualinspection.包装批记录上填写第一页的台头部分,并附相应的标准物料单，疫苗/稀释液比利时检验报告封面,每页右上角敲指令号的章.相应数据源参见附件一Fillheadinginformationonthefirstpageofbatchrecord,enclosedwithBOMandSFG/diluentCOAcoverandstampthenumberattoprightcorneroneachpage,Dataresourcerefertoappendix1.批量原则如下:BatchQtyprincipleasfollow:半成品批量基本根据订单需求制定，PFS装疫苗按整盒发放,VIAL装疫苗可拆零发放，每盒Akilux最多只能拆一次零头TheruleforSFGallocationismainlyaspersalesorder,thevaccineswithPFSpresentationmustbesenttoPKwithfullbox,forvialpresentation,thepartialquantityisallowedbutonlyforonce.GLAXOSMITHKLINEBIOLOGICALS(SHANGHAI)LTD上海葛兰素史克生物制品有限公司Doc.No.:VS001编号：VersionNo.:9.0版本号Page5of9页数EffectiveDate:生效日期Anyprintedcopyofthisdocumentis