DMR要求培训课件

DMR对于每中设备的DMR应包括或参照:设备的规范,包括适当的图纸,成分,公式,组件的规范和软件规范生产过程规范包括,适当的设备规范,生产方法,生产程序和生产环境规范质量包装程序和规范包括,接受标准和使用的质量保证设备保证和标签规范,包括使用的方法和过程安装,维护和服务程序和方法DMR1.0 DeviceMasterRecordIndexThedevicemasterrecordIndexisatableofcontentswhichisusedforconvenience.Itmaybeknownasa:DeviceMasterRecordIndexDocumentationorDeviceMasterRecordUnit;DocumentationPlan;ProductTree;DocumentationIndex;ProductStructure;orBillofMaterials(ifitalsoliststhedevicemasterrecorddocuments).2.0 DeviceSpecifications(Devicespecificationsaredescribedinthechaptertext.)DMR3.0 ManufacturingInformation3.1 Index(Optional.See1.0abovefortotaltableofcontents.)3.2 Formulationortopassemblydrawing3.3 Listofcomponents1. Listofingredients(includinggradeortype)2. Billofmaterials(i.e.,componentlistusuallyarrangedbysubassemblyorothersubproductlevelorbyprocesssteps)3. Formula3.4Procurementdocumentation1. Specifications2. Drawings3. Certificateofcompliancerequirements4. SupplierAssessmentproceduresDMR3.5 Devicedocumentation1. Fabricationdrawings2. Surfacefinishprocedures3. Subassemblydrawings4. Wiringandpipingdiagrams5. Assemblyprocedures6. Assemblydrawings7. Referencedocumentationa.Wiringandpipingschematicsb. Testspecifications8. Subbatchprocedures9. Blendingormixingprocedures10. Solutionprocedures11. Finalformulationprocedures12. SoftwarepackagesDMR3.6 Precautionsandspecialnotations1. Apparel2. Cleaning3. Storageconditions4. Filling,mixingconditions5. HazardsandsafetyprecautionsDMR3.7 Equipment,lines,andprocedures1. Processlines2. Assemblylines3. Vessels4. Mixers,tools5. Molds6. Machinemaintenanceprocedures7. Calibrationprocedures8. Setupprocedures9. Operatingprocedures10. ProcessflowchartsDMR3.8 Sterilizationprocedures1. Proceduresforethyleneoxide,radiation,filtration,steam,etc.2. Handlingandflowprocedures3. Cycleparameterspecifications4. DiagramsforloadingproductsinthechamberDMR3.9 Productioncontroldocumentation1. Inspectionprocedures2. Testprocedures3. Blankjobtravelers4. Blankinspection/testforms5. Instrumentcharts6. ReportingformsDMR4.0 LabelingandPackaging4.1 Index(Optional.see1.0above.)4.2 Labeling1. Labeldrawings2. Labelingdrawings3. Label/labelingreviewproceduresandforms4. Productioncontrolproceduresandhistoryrecordforms5. Instructionmanuals6. Servicemanuals7. Customersoftware8. CustomerfeedbackformsDMR4.3 Packaging1. Packagedrawings(usuallyincludeslabelinginformation)2. Closuredrawings3. Fillingand/orpackagingprocedures4. Packingprocedures5. Specialshipmentprocedures4.4 Storagerequirements1. Temperature2. Humidity3. ShelflifeDMR5.0 ControlProceduresandActivities5.1 Index(optional.see1.0above.)5.2 Inspectionprocedures1. Incoming2. Inprocess3. Finisheddevices4. Processcontrolcharts5. BlankdatareportingformsDMR5.3 Testprocedures1. Incoming2. Inprocess3. Pretestconditioning4. Finisheddevice5. Processcontrolcharts6. Blankdevicehistoryrecordforms7. Automatedtestprogramsand/orsoftwareDMR6.0