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1、CompanyNameCompanyGroup,Division,LocationProductName:ProductNameDocumentTitle:ValidationMasterPlanDocumentNumber:DocumentNumberDocumentFilename:DocumentFilenameCONTROLLEDCOPY/MASTERCOPYSTAMPHEREOTHERSTAMPHERERevisionLevelRevisionDateDCO/ECONumberDescriptionofRevisionRevisionAuthorDRAFTDD/MM/YYYY-OOO
2、OODraftAuthorName1.00DD/MM/YYYY-OOOOOInitialReleaseAuthorNameTableofContents1.0Purpose22.0Scope23.1 DefinitionOfTerms23.1 ContractManufacturer23.2 InstallationQUal而Cation(IQ)23.3 OperationalQualification(OQ)23.4 PerformanceQualification23.2 References25.0ResponsibilitiesandRequirements26.1 Validatio
3、nPlan26.1 ComponentXManufacturing26.1.1 Components:26.1.2 Qualifications:36.2 InstrumentsZEquipment36.2.1 Off-the-shelf36.2.2 Custom36.3 Software36.4 FacilitiesSystems36.5 Suppliers36.6 ValidationTestingandStandardsforProductHandling,StorageandDistribution36.7 PluctSystemValidation36.2 Flowcharts4Ta
4、blesandFiguresTableZFigure!.TableName4TableZFigure2.FigureName4TableZFigure3.TableName41.0PurposeThepurposeofthisdocumentistospeciProductNamemanufacturingprocessvalidationplanstoensurethattheproductmeetsitsspecificationsandintendeduse.2.0ScopeThisdocumentappliestoallfacilities,equipmentandprocessest
5、hataresubjecttotheFoodandDrugAdministrationQualitySystemRegulations.Thescopeofthisdocumentincludesbutisnotlimitedtofacilities,manufacturingequipment,analyticalequipment,calibration,testequipment,computerrelatedsystems,processesandtestmethodsusedinthemanufactureofProductName.3.0DefinitionOfTerms3.1 C
6、ontractManufacturerAcompanythatprovidesoutsourcedprocessdevelopment,manufacturingandpackagingservicesforafee.3.2 InstallationQualification(IQ)Amethodforestablishingdocumentedevidenceinprotocolandreportformthatprocessequipmentandassociatedsysteminstallationsadheretodesigncriteriaandthattherecommendat
7、ionsofthemanufacturerareconsidered.3.3 OperationalQualification(OQ)Amethodforestablishingdocumentedevidenceinprotocolandreportformthatoperationalparametersofequipmentresultinproductthatmeetsallpredeterminedspecifications.3.4 PerformanceQualificationAmethodforestablishingdocumentedevidenceinprotocola
8、ndreportformthataprocesswillconsistentlyproduceacceptableproductundernormaloperatingconditions.4.0References21CFRpart820QualitySystemRegulation,820.75MedicalDeviceQualitySystemsManual,FDA97.4179FDAProcessValidationGuidance5.0ResponsibilitiesandRequirementsTheQualityandEngineeringdepartmentsarerespon
9、siblefortheadministrationandmanagementofthevalidationprogram,andserveasprimaryresourcestodeterminevalidationrequirements,andtowrite,review,andapprovevalidationprotocols.6.0ValidationPlan6.1 ComponentXManufacturing6.1.1Components:ComponentsSourceComponentIContractManufacturer(CM)Component2Purchasedfr
10、omapprovedvendorComponent3CMtomanufacture6.1.2Qualifications:ProcessEquipmentIQOQPQPerformedBvProcessIArborPressXProcess2UltrasonicWelderXXProcess3HeatSealerXXX6.2 InstrumentsZEquipment6.2.1 Off-the-shelfIndividualperformancevalidationswillnotbeconductedonoff-the-shelfinstruments,howeveraperformance
11、qualificationwillbeperformedontheentiretestsystem.Insertoff-the-shelfequipmentlisthere6.2.2 CustomInsertcustommadeequipmentlisthere.6.3 SoftwareSoftwaredesignanddevelopmentwillsatisfytherequirementsofInsertrequirements.Itwillbevalidateddescribevalidationplans.6.4 FacilitiesSystemsInsertfacilitiesreq
12、uirementshere.6.5 SuppliersSupplierswillbequalifiedandmanagedinaccordancewithCompanyNameSupplierControlstandardoperatingprocedures.6.6 ValidationTestingandStandardsforProductHandling,StorageandDistributionInsertvalidationplansforpackaging,shippingandhandling.6.7 ProductZSystemValidationInsertproductvalidationplans.Table NameFigure Name Table Name7.0FlowchartsTableZFigure1.TableZFigure2.TabIeZFigurc3.
