验证主计划模板.docx

Company NameCompany Group, Division, LocationProduct Name: Product NameDocument Title: Validation Master PlanDocument Number: Document NumberDocument Filename: Document FilenameCONTROLLED COPY/ MASTER COPY STAMP HEREOTHER STAMP HERERevision LevelRevision DateDCO/ECO NumberDescription of RevisionRevision AuthorDRAFTDD/MM/YYYY-00000DraftAuthor Name1.00DD/MM/Y YYY-00000Initial ReleaseAuthor NameValidation Master PlanDocument Number Rev x.xx DD/MM/YYCompany NameCompany Group, Division, LocationProduct NameTable of Contents1.0Purpose22.0Scope23.0Definition Of Terms23.1 Contract Manufacturer23.2 Installation QualiGcation (IQ)23.3 Operational Qualification (OQ)23.4 Performance Qualification24.0References25.0Responsibilitiesand Requirements26.0Validation Plan26.1 Component X Manufacturing2Components:26.1.1 Qualifications:36.2 Instruments/Equipment3Off-the-shelf36.2.1 Custom36.3 Software36.4 Facilities Systems36.5 Suppliers36.6 Validation Testing and Standards fbr Product Handling, Storage and Distribution36.7 Product/System Validation37.0 Flowcharts4Tables and FiguresTable/Figure I.Table Name4Table/Figure 2. Figure Name4Table/Figure 3.Table Name4Document FilenameDocument FilenameCOMPANY PROPRIETARY AND CONFIDENTIALPage 1 of 4Validation Master PlanDocument NumberRev x.xx DD/MM/YYValidation Master PlanDocument NumberRev x.xx DD/MM/YYCompany NameCompany Group, Division, Location(Product Name1.0 PurposeThe puipose of this document is to specify Product Name manufacturing process validation plans to ensure that the product meets its specifications and intended use.2.0 ScopeThis document applies to all facilities, equipment and processes that arc subject to (he Food and Drug Adniinistration Quality System Regulations. The scope of this document includes but is not limited to facilities, manufacturing equipment, analytical equipment, calibration, test equipment, computer related systems, processes and test methods used in (he manufacture of Product Name.3.0 Definition Of Terms3.1 Contract ManufacturerA company that provides outsourced process development, manufacturing and packaging services for a fee.3.2 Installation Qualification (IQ)A method for establishing documented evidence in protocol and report form that process equipment and associated system installations adhere to design criteria and that the recommendations of the manufacturer are considered.3.3 Operational Qualification (OQ)A method for establishing documented evidence in protocol and report form that operational parameters of equipment result in product that meets all predetermined specifications.3.4 Performance QualificationA method for establishing documented evidence in protocol and report form that a process will consistently produce acceptable product under normal operating conditions.4.0 References2I CFR part 820 Quality System Regulation, 820.75Medical Device Quality Systems Manual, FDA 97.4179FDA Process Validation Guidance5.0 Responsibilities and RequirementsThe Quality and Engineering departments are responsible for the administration and management of the validation program, and serve as primary resources to determine validation requirements, and to write, review, and approve validation protocols.6.0 Validation Plan6.1 Component X ManufacturingDocument FilenameDocument FilenameCOMPANY PROPRIETARY AND CONFIDENTIALPage 2 of 46.1.1 Components:ComponentsSourceComponent IContract Manufacturer (CM)Component 2Purchased from approved vendorComponent 3CM to manufactureValidation Master PlanDocument NumberRev x.xx DD/MM/YYValidation Master PlanDocument NumberRev x.xx DD/MM/YYCompany NameCompany Group, Division, Location(Product Name6.1.2 Qualifications:ProcessEquipmentIQOQPQPerformed ByProcess 1Arbor PressXProcess 2Ultrasonic WelderXXProcess 3Heat SealerXXX6.2 Instruments/EquipmentOff-the-shelfIndividual performance validations will not be conducted on off-the-shelf instruments, however a performance qualification will be performed on the entire test system.Insert off-the-shelf equipment list hereCustom(Insert custom made equipment list here.6.3 SoftwareSoftware design and development will satisfy the requirements of Insert requirements.It will be validated describe validation plans.6.4 Facilities Systems(Insert facilities requirements here).6.5 SuppliersSuppliers will be qualified and managed in accordance with Company Name Supplier Control standard operating procedures.6.6 Validation Testing and Standards for Product Handling, Storage and Distribution(Insert validation plans fbr packaging, shipping and handling.6.7 Product/System ValidationInsert product validation plans.Document FilenameCOMPANY PROPRIETARY AND CONFIDENTIALPage 3 of 4Validation Master PlanDocument NumberRev x.xx DD/MM/YYCompany NameCompany Group, Division, Location(Product Name7.0FlowchartsTable/Figure 1. Table NameTable/Figure 2. Figure NameTable/Figure 3. Table NameDocument FilenameCOMPANY PROPRIETARY AND CONFIDENTIALPage 4 of 4