批生产指令管理规程(英文)GMPDocumentTitle:ManagementProceduresforBatchProductionOrderDraft:MMDDYYDocumentNumber:SMP-PR-03-002-00Checkedby:MMDDYYEffectiveDate:MMDDYYAuthorizedby:MMDDYYPage:1/2Issuedby:productiondepartmentDistributedto:workshop,qualitydepartment,product...
GMPDocumentTitle:ManagementProceduresforBatchProductionOrderDraft:MMDDYYDocumentNumber:SMP-PR-03-002-00Checkedby:MMDDYYEffectiveDate:MMDDYYAuthorizedby:MMDDYYPage:1/2Issuedby:productiondepartmentDistributedto:workshop,qualitydepartment,productionmaterialcontroldepartment,productiondepartmentBackupnumber:04Reasonsforchange1.Purpose:toestablishmanagementproceduresforbatchproductionordertoensureorderlyproductionandpackaging.2.ApplicationRange:theproceduresareapplicabletomanagementofbatchproductionorder.3.Responsibility:headanddispatchersofproductiondepartment,workshoptechnologistsareresponsibleforimplementationoftheprocedures.4.Contents:4.1Managementof“batchproductionorder”:4.1.1“Batchproductionorder”ispreparedbydispatchersofproductiondepartmentaccordingtoproductionplan2daysbeforeformalproduction,andissuedafterexaminationandapprovalofheadofproductiondepartment.4.1.2“Batchproductionorder”ismadeinquadruplicate,oneforproductionworkshop,productiondepartment,qualitydepartmentandproductionmaterialcontroldepartment,respectively.4.1.3Contentof“batchproductionorder”:4.1.3.1Dateofpreparation,approvalnumber4.1.3.2 Name,specification,packingspecification,formulation,batchquantity,manufacturedateoftheproduct,andexecutionobjectof“batchproductionorder”.4.1.3.3 Contentofmainformula:4.1.3.3.1Basisofpreparation4.1.3.3.2Prescription4.1.3.3.3Name(legalname)andstandardprescriptiondose,specification,unitofrawandsubsidiarymaterials4.1.3.4 Signatureofpreparerandapproverof“batchproductionorder”.4.1.4 Mattersneedingattention4.1.4.1Thebatchquantityofeachvarietymustbestable.4.1.4.2Measurementunitshallbeunified.4.1.4.3Percentagelimitexceedingthepredeterminedingredientamountshallbeindicated.4.1.4.4Specialrequirementsforrawandsubsidiarymaterialsshallbeindicatedinremarkscolumn.4.2Theaboveordershallnotberandomlychangedonceissued,andmustbestrictlyimplemented.Reasonablechangemaybemadeaftercommunicationandcoordinationwithproductiondepartmentincaseofanydoubt.Whenthenewordersubjecttoreasonablechangeisissued,theoriginalorderiswithdrawnanddestroyedbyproductiondispatchers.4.3 Thequalitydepartmentpreparescorrespondingtestinginstrumentsandreagentsafterreceivingtheorder.4.4Productionmaterialcontroldepartmentshalltimelypreparecorrespondingrawandsubsidiarymaterials,packingmaterialsandarticlesforproductionafterreceivingtheordertoavoiddelayingproductionduetoinadequatepreparation.5.Supplementaryprovisions:ListofreferencerecordsinthispaperSerialNumberRecordNameRecordNumberRemarks1BatchProductionOrderSMP-PR-03-001-R-01-006.Thisdocumentisdraftedbyproductiondepartment,auditedbyheadofproductiondepartmentandapprovedbyviceproductiongeneralmanager.
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