DMR要求培訓(xùn)課件

DMR對于每中設(shè)備的DMR應(yīng)包括或參照:設(shè)備的規(guī)范,包括適當(dāng)?shù)膱D紙,成分,公式,組件的規(guī)范和軟件規(guī)范生產(chǎn)過程規(guī)范包括,適當(dāng)?shù)脑O(shè)備規(guī)范,生產(chǎn)方法,生產(chǎn)程序和生產(chǎn)環(huán)境規(guī)范質(zhì)量包裝程序和規(guī)范包括,接受標(biāo)準(zhǔn)和使用的質(zhì)量保證設(shè)備保證和標(biāo)簽規(guī)范,包括使用的方法和過程安裝,維護(hù)和服務(wù)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