BM双语英汉批生产记录模板,中美双报

XXX制药有限公司XXXPharmaceuticalsCo.,Ltd.批制作记录BPRForManufacture产品名称（通用名）/规格：ProductName/Strength:XXXX/0.5gXXXtablet产品代号：ProductcodeXXX页数：Page1/53工艺规程编号/版本号：ManufactureprocessdocNo./VersioXXX批记录编号/版本号：iBPRdocNo./VersionXXX起草人：Writtenby日期：Date批准人：Approvedby日期：Date执行日期：Implementationdate:审核人：Verifiedby日期：Date产品批号：BatchNo.填写人：Writtenby日期：Date复核人：Verifiedby日期：Date生产日期：ManufactureDate年月日Yearmonthday批产量：Batchsize750,000Tab.口FetteP2020口GEACourtoyModu1TMD产品有效期：Shelflife3年years填写人：Writtenby日期：Date复核人：Verifiedby日期：Date后效期至：Expirydate年月Yearmonth批记录审核BatchRecordReview部门Department日期Date审核人Reviewedby生j郃Production年月日Yearmonthday质量保证部QA年月日Yearmonthday

产品名称（商品名）/规格：ProductName/Strength:XXX/0.5gXXX/0.5g产品代号ProductCode:XXX产品批号：BatchNo.批记录编号/版本号：BPRdocNo.:XXX产品分步收率TabletingYield压片工序收率TabletingYieldlimitsforFetteP2020:98.5%~100.5%;TabletingYieldlimitsforGEACourtoyModulTMD:95.0%〜100.5%;Reconciliation:99.0%~100.3%；FetteP2020压片收率限度98.5%〜100.5%;GEACourtoyModu1TMD压片机压片收率限度95.0%〜100.5%;物料平衡限度99.0%〜100.3%Date日期GranuleWeight颗粒重量ATab.TotalWeight片子重量BAverageTab.Weight平均片重CTab.Quantity素片数量D=1000B/CWaste废料量EReconciliation物料平衡=（B+E）/AX100%TabletingYield压片分步收率=B/AX100%Recordedby记录人Reviewedby复核人kgkg_.g片kg%%CoatingYield包衣工序收率（Limits限度：99.7%〜100.5%）Date日期CoatedTab.TotalWeight包衣片重量HAverageCoatedTab.Weight包衣片平土匀重量ICoatedTab.Quantity包衣片数量J=1000H/ICoatingYield包衣分步收率=J/GM00%QASamplingQuantityQA取样量Recordedby记录人Reviewedby复核人kg_.g片%片需要说明的情况Comments:生厂主管/日期Supervisor/Date:

产品名称（商品名）/规格：ProductName/Strength:XXX/0.5gXXX/0.5g产品代号ProductCode:XXX产品批号：BatchNo.批记录编号/版本号：BPRdocNo.:XXXCoatingMaterialDispensing配料工序1.Preparation&inspectionbeforedispensing配料前准备和检查：CampaignInfo.连续配料信息BatchNo.ofthiscampaign本次连续配料的产品批号：Thesequencenumberofthisbatchincampaign本批为本次连续配料的第几批：Ifthisbatchisthebeginningofthecampaign,Recordinfo.asfollowed,andAffixthelastandre-cleaninglabelsonthepage4ofthefirstbatchrecordincampaign.若本#匕产品为连续配料的第一批，则记录以下信息，并将清洗/＜新清洗合格证贴于本次连续配料第1批的第4页。Cleanedafterpreviousbatchfinished上批广品配料结束，是否进行清场操作：Y口N口Productname产品名称：Batch批号：Date日期：..Rooms&EquipmentareWithincleaningexpiry设备与房间在清洗存放周期内Y口N口Ifoutofonemonth,shutdownHVACmorethan3daysoraftermaintenance,pls.cleanagain.存放超过1个月，HVAC停机超3天，或经维修后等情况；需要重新进行彻底清洗Y口N口CleaningInspectionRecords清场检查记录InspectionList,Confirmedby”vftj底清洗检查内容（打确认）Roomandequipmentstatusarecorrect.房|可和设备的状态标识止确。Y口N口Dispensingroomcleaniscompliance.酉己料1日」卫生符合要求。Y口N口Nomaterialanddocumentofpreviousbatchinthearea无上批遗留的物料和文件等。Y口N口RelatedInstrumentsareintheshelflifeofcalibration.各相关仪器仪表已经校验，并在有效期内。Y口N口Signature签名Inspectedby/date/time检查人/日期/时间Reviewedby/date/time复核人/日期/时间产品名称(商品名)/规格：ProductName/Strength:XXX/0.5gXXX/0.5g产品代号ProductCode:XXX产品批号：BatchNo.批记录编号/版本号：BPRdocNo.:XXX清洗证粘贴处Affixcleaninglabels(LPM004)here.若没有，划去此格Ifnone,ignorethiscell.原辅料配料单粘贴处Affixpicklist(RBM-1103)here

产品名称(商品名)/规格：ProductName/Strength:XXX/0.5gXXX/0.5g产品代号ProductCode:XXX产品批号：BatchNo.批记录编号/版本号：BPRdocNo.:XXX2.Balanceinformation配料操作所用电子秤Balance所用电子秤Balancetype设备型号KCC150sXP16001LBalanceIDnumber以备编力PH-1207-MEPH-1208-MEMaximumweightvalue取人称重值150kg16kgWeighingaccuracy称里精度由0gvg3.Recordthetemperature,humidity,differentialpressureatthestartingtime.操作前记录操作间的温湿度、压差，符合规定才能进行生产。Room房问号Startdate/time开始日期/时间.__.__/__.__314Temperature温度(18〜26c)CRelativehumidity相对湿度(35〜65%)%309Roomdifferentialpressure房间压差(15pa)pa310Roomdifferentialpressure房间压差(>5pa)pa315Roomdifferentialpressure房间压差(>5pa)pa316Roomdifferentialpressure房间压差(>5pa)paRecordedBy记录人4.InformationofPEbag所使用的PE塑料袋信息RecordtheGR.No.ofPEbag记录配料所用PE塑料袋入厂号信息。Size规格GR.No.入厂号：1kg5kg30kgRecordedBy记录人

产品名称(商品名)/规格：ProductName/Strength:XXX/0.5gXXX/0.5g产品代号ProductCode:XXX产品批号：BatchNo.批记录编号/版本号：BPRdocNo.:XXX配料操作过程中，应佩戴3M8210V防尘口罩和防护手套，并在称量罩内进行。Duringdispensingoperation,operatorsmustweardustmasks(3M8210V)andgloves,anderateinweighingbooth.5.Materialconfirmation:confirmmaterialinformationonthelabelisconsistentwiththefollowingtablebeforedispensing.物料确认：确认待配物料的收料标签卡上的物料名称、代号、入厂号与下表中的一致，然后进行称量操作Code原辅料代号Materialname原辅料名称Theoreticalweight/batch批理论发料量Actualweight批实际称量GR.No.入厂号XXXXXXXXXkgXXXXXXXXXkgXXXXXXXXXkgXXXXXXXXXkgXXXXXXXXXkgXXXXXXXXXkgInspectedby/date/time检查人/日期/..Reviewedby/date/time复核人/日期/..Confirmdispensedmaterialinformationonthelabelisconsistentwiththepicklist,AffixthepicklistonthePage4.检查产品名称，批号等无误后将配料单粘于第四页。6.Enddispensing结束配料Enddate/time配料操作结束日期/时间../.Recordedby记录人

产品名称（商品名）/规格：ProductName/Strength:XXX/0.5gXXX/0.5g产品代号ProductCode:XXX产品批号：BatchNo.批记录编号/版本号：BPRdocNo.:XXXCleaningInfo.清场信息BatchNo.ofthiscampaign本次连续配料的厂品批号Cleaningornotafterthisbatch本批配料结束，是否需要彻底清洗操作丫口NDStartdate/time清场开始日期/时间.__.__/__.__AfterClearanceorCleaning,Confirmedthelistby―;清场后检查，打“V确认Room&airlock房间及通道CleaningresultofFloor/wall/door/window/deskarecompliant房间区域/地面/门窗/墙间和操作台符合要求。CleaningresultofCeiling/pipes/inlet&outletarecompliant房间天花板、进/回风口、管道均已经清洁且符合要求。Thereisnomaterialanddocumentrelatetolastbatch.生厂现场/、存在前次生广的遗留物。Thewastehasbeencleanedup.房I可内垃圾已经清除。Thereisnoitemunrelatedproduction.生厂现场/、存在与生）尢关的物口口。Thestatuslabelsofroomsarecorrect.房间的状态标识止确。Material物料Thematerialhasbeenremovedfromdeskandbalance.已经将操作台、天平的表面的原辅料清除。Thematerialhasbeenremovedfromtheroom.已经将原辅料从房间清除。Documents文件Documentsarerelatedthisbatchhavebeenremoved.启美的文件和记录（包括批记录、表格等）已经消除。Thelabelsofthisbatchhavebeencleanedup.将前一■批次产品的标识清除。Thecleaningrecordhasbeencompleted.启关清洗的相关记录已经填与完整。Signature签名Enddate/time清场结束日期/时间.__.__/__.__Inspectedby/date/time检查人/日期/时间/_.__.__/__._Reviewedby/date/time复核人/日期/时间/_.__.__/__._Reviewedby/date/timeQA/日期/时［可/_.__.__/__._Clearanceresultneedtobecheckedandreviewedbyoperators,Cleaningresultneedtobecheckbyoperator、reviewedbysupervisorandQA.注：批问清场操作人员和复核人检查合格即可；彻底清洗后需操作人员、主管、QA检查合格，并将清洗证挂在指定的位置

产品名称（商品名）/规格：ProductName/Strength:XXX/0.5gXXX/0.5g产品代号ProductCode:XXX产品批号：BatchNo.批记录编号/版本号：BPRdocNo.:XXXGranuleDispensing投料工序1.Preparation&inspectionbeforedispensing投料前准备和检查:CampaignInfo.连续生产批次信息BatchNo.offirstBatchinthiscampaig®底清场后连续生产第一■批的批号DateoffirstBatch彻底清场后连续生产第一批开始时间..BatchSequenceincampaig^批为本次连续生产的第升Ifthisbatchisthebeginningofthecampaign,Recordinfo.asfollowed,andAffixthelastandre-cleaninglabelsonthepage9ofthefirstbatchrecordincampaign.若本#匕产品为连续投料的第一批，则记录以下信息，并将清洗/重新清洗合格证贴于本次连续投料第1批的第9页。Cleanedafterpreviousbatchfinished上批产品投料结束，是否进行彻底清场：Y口N口Productname广品名称：Batch批号：Date日期：..Rooms&EquipmentareWithincleaningexpiry设备与房间在清洗存放周期内Y口N口Ifoutofonemonth,shutdownHVACmorethan3daysoraftermaintenance,pls.cleanagain.存放超过1个月，HVAC停机超3天，或经维修后等情况；需要重新进行彻底清洗Y口N口CleaningInspectionRecords清场检查记录InspectionList,Confirmedby"查内容检查结果（打“烦!认）Clearance批间清场Cleaning彻底清洗CorrectlabelforRoom&equipment房间和设备的状态标识止确。CompliantRoomcleaningresult投料房间卫生符合要求。VentofBINislocked确认BIN的呼吸於正否关闭，完整。Nomaterial&documentsrelatetolastbatch无上批遗留的物料和文件等。RelatedInstrumentsareintheshelflifeofcalibration各相关仪器仪表已经校验、并在有效期内。Y口N口Complianttemperature&humidity房间压差付合要求Y口N口Signature签名Inspectedby/date/time检查人/日期/时间/_._.__/__.―Reviewedby/date/time复核人/日期/时间/_._.__/__.―

产品名称(商品名)/规格：ProductName/Strength:XXX/0.5gXXX/0.5g产品代号ProductCode:XXX产品批号：BatchNo.批记录编号/版本号：BPRdocNo.:XXX2.BINRecord物料容器使用记录NO.ofBIN料斗编号Cleaningorclearanceafterlastbatch该BIN上批产品清场操作的清场类型：口彻底清洗口批问清场BatchNo.offirstBatch该BIN本次连续生厂第一■批的批号StartedtimeoffirstBatch该BIN本次连续生厂第一■批开始日期..BatchSequenceincampaigt批为该BIN连续生产的第批清洗证粘贴处Affixcleaninglabels(LPM004)here.

若没有，划去此格

Ifnone,ignorethiscell.

产品名称（商品名）/规格：ProductName/Strength:产品代号ProductCode:XXX/0.5gXXX产品名称（商品名）/规格：ProductName/Strength:产品代号ProductCode:XXX/0.5gXXXXXX/0.5g产品批号：BatchNo.批记录编号/版本号：BPRdocNo.:XXXDuringcharging,operatorsmustwear3Mautomaticmasksandglov曲料过程中，应佩戴防护手套和佩戴3M电动送风防尘头罩;Room房间号Equipment使用设备Date/Time日期/时间._.__/__.__305NZQ400-1200-PD-S4Vacuumcharger真空上料机Roomtemperature房间温度CRoomrelativehumidity房间相对湿度%Roomabsolutehumidity房间对应的绝对湿度（＜4.5g水/kg干空气）gH2O/kgairP.Airlockdifferentialpressure人流向Hslh(>5pa)paM.Airlockdifferentialpressure物加M可(15pa)paInspectedby检查人4、TaretheBIN(1600L)bythebalance(KES1500SK)firistly；ClosethelowervalveandopentheDepakinegranulepackage,chargetoBINbythevacuumdevice；Closetheuppervalveandmoveto352,thenweighandrecordit.将1600L容量的混合料斗先置于1.5t电子称(型号：KES1500SK)上去皮;关闭混合料斗底阀，打开装有xxx预混颗粒的塑料袋’用真空上料机抽入1600升容量料斗中。Qty.ofmaterialpackages投料桶数Qty.ofdesiccative干燥剂包数NetweightQty.ofmaterialpackages投料桶数Qty.ofdesiccative干燥剂包数Netweight颗粒净重Operatedby操作人Reviewedby复核人产品名称（商品名）/规格：ProductName/Strength:XXX/0.5gXXX/0.5g产品代号ProductCode:XXX产品批号：BatchNo.批记录编号/版本号：BPRdocNo.:XXXRoom305Startdate/time涓场开始日期/时间.__.__/_.―AfterClearanceorCleaning,Confirmedthelistby"，”；清场后检查，打确认口批间清场口彻底清洗Room&airlock房间及通道CleaningresultofFloor/wall/door/window/deskarecompliant房间区域/地面/门窗/墙间和操作台符合要求。CleaningresultofCeiling/pipes/inlet&outletarecompliant房间天花板、进/回风口、管道均已经清洁且符合要求。NAThereisnomaterialanddocumentrelatetolastbatch.生广现场/、存在前次生广的遗留物。Thewastehasbeencleanedup.房