Pharmaceutical Master Validation Plan

The Ultimate Guide to FDA, GMP, and GLP Compliance
1. Auflage 2001
ISBN: 978-1-57444-330-1
Verlag: Taylor & Francis Inc

Buch, Englisch, 208 Seiten, Format (B × H): 156 mm x 246 mm, Gewicht: 440 g

The Master Validation Plan provides a roadmap to management for on-time start-up of facility operations, and validation of existing facilities, in compliance with GMP requirements. The lack of a comprehensive Master Validation Plan and well-documented validation procedures is the main reason that new drug, medical device, medical equipment, and related product applications are rejected by the FDA. In fact, only about 2% of the applications submitted by foreign pharmaceutical companies are approved each year. This thorough guide provides the needed solutions and guidance for both foreign and U.S. companies to achieve FDA compliance and authorization to market their products in the United States. Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance will allow you to more easily achieve satisfactory inspections, new medical product approval, minimize non-conformance, reduce rework and rejected lots, and avoid recall lots by developing and managing a Master Validation Plan. The accompanying CD allows users to input the template plan into their computers and tailor it to incorporate additional regulatory requirements specific to individual companies worldwide and print the required documents. Together, the book and CD contain everything required to develop and execute a successful Master Validation Plan based on FDA guidelines for the pharmaceutical industry, and allows the templates to be extended to diagnostic products, medical device, medical equipment, and biotech industry products.

Zielgruppe

Healthcare management quality assurance managers, operations managers, executives, and quality engineers; validation designers, internal auditors, and external auditors; industrial engineers and manufacturing engineers; mechanical engineers, computer engineers, utilities engineers; chemical engineers

Autoren/Hrsg.

Haider, Syed Imtiaz (Julphar Gulf Pharmaceutical Industries, United Arab Emirates)

Haider, Syed Imtiaz

Fachgebiete

• Wirtschaftswissenschaften Wirtschaftssektoren & Branchen Fertigungsindustrie Pharmaindustrie

Inhaltsverzeichnis

INTRODUCTIONProject DescriptionWhat is a Validation Master PlanScope of a Validation Master PlanDefinition of the Term ValidationValidation Team MembersValidation Team ResponsibilitiesCONCEPT OF QUALIFICATION / VALIDATIONFundamentalsConcept of a Validation Life CycleElements of Qualification/ValidationDocumentation Format of Qualification ProgramsNumbering SystemREVALIDATIONRESPONSIBILITIESFACILITY DESCRIPTIONLine CapacitiesDESCRIPTION OF BUILDINGDry Production Facility: Building ALiquid and Semisolid Production Facility: Building BParenterals Production Facility: Building CEQUIPMENT DESCRIPTIONDry Production Facility: Building ALiquid and Semisolid Production Facility: Building BParenterals Production Facility: Building COver- Printing AreaQuality ControlQuality Assurance (In-Process)Product Development LaboratoriesHVAC DESCRIPTIONDry Production Facility: Building ALiquid and Semisolid Production Facility: Building BParenterals Production Facility: Building COver-Printing AreaQuality ControlQuality Assurance (In-Process)Product Development LaboratoriesUTILITIES DESCRIPTIONDeionized Water (DI Water)Purified WaterWater for Injection (WFI)Chilled WaterPure SteamCompressed AirNitrogen (N2)Carbon Dioxide (CO2)Electric PowerSanitary WaterHVAC (Heating, Ventilation, and Air Conditioning) SystemVALIDATION PROGRAM OVERVIEWValidation Project Management: OrganizationValidation ResponsibilitiesDesign and Validability ReviewValidation DocumentsInstallation Qualification ProtocolsOperational Qualification ProtocolsChange Control InitiationCycle DevelopmentPerformance Qualification ProtocolsProcess Validation ProtocolsValidation Final ReportsValidation PackageCertificate for Use in ManufacturingRequired Protocols and Procedures for Dry Production: Building ARequired Protocols and Procedures for Liquid and Semisolid Production: Building BRequired Protocols and Procedures for Parenterals Production: Building CCALIBRATION PROGRAM SUMMARYPREVENTATIVE MAINTENANCE PROGRAM SUMMARYKEY STANDARD OPERATING PROCEDURES (SOPS)VALIDATION OF BUILDING Civil WorkDrainage SystemVALIDATION OF UTILITY SYSTEMS Plant SteamPure SteamWater for Injection (WFI)Compressed AirNitrogen (N2)Heating Ventilation and Air Conditioning (HVAC)Emergency Power (Standby Generator)PROCESS DESCRIPTION BUILDING A DRY PRODUCTION: BUILDING AProcess Flow, Variables and Responses: TabletsProcess Flow, Variables and Responses Powder for SuspensionProcess Flow, Variables and Responses: CapsulesPROCESS DESCRIPTION LIQUID AND SEMISOLID PRODUCTION: BUILDING BProcess Flow, Variables, and Responses: Syrup, Suspension, and Drop ProductsProcess Flow, Variables and Responses: Cream Ointment, and Suppository ProductsPROCESS DESCRIPTION FOR PARENTERALS PRODUCTION FACILITY: BUILDING CProcess Flow, Variables, and Responses: Aseptic Fill ProductsProcess Flow, Variables, and Responses: Ready-to-Use Disposable SyringesProcess Flow, Variables, and Responses: Terminal Sterilization ProductsProcess Flow, Variables and Responses: Lyophilized ProductsQUALIFICATION OF PROCESS EQUIPMENTCommuting MillDryerV-Shell BlenderTablet CompressionCapsulationPowder FilingCapsule PolisherTablet CoatingSyrup Manufacturing VesselSuspension Manufacturing VesselDrops Manufacturing VesselMixerFilter PressCream/Ointment/Suppository Manufacturing VesselSyrup, Suspension, and Drop Filling MachineCream and Ointment Filling MachineSuppository Filling MachineLabeling MachineCapping MachineCartonatorShrink-Wrapping MachineOver-Printing MachineAutoclave (Steam Sterilizer)Hot Air Tunnel (Dry Heat Sterilizer)Vials / Ampoules Washing MachineVials / Ampoules / Syringes Filling MachineFreeze Dyer (Lyophilizer)Laminar Flow UnitPass ThroughVALIDATION OF SUPPORT PROCESS Washing of ComponentsSterilization of ComponentsDepyrogenation of ComponentsAseptic Filling Validation (Media Fill Studies)Cross-Contamination ControlComputerized Pharmaceutical SystemQUALITY ASSURANCE / CONTROL LABORATORY VALIDATIONLaboratory Equipment QualificationComputer Related Systems in QA/QC LaboratorycGMP PROCEDURES AND PROGRAMSEngineering Change ControlCalibrationPreventive Maintenance ProgramStandard Operating Procedure (SOPs)Facility Cleaning and SanitizationEnvironmental Monitoring ProgramHEPA Filter Integrity TestingFilter Integrity TestingLabel Control ProgramcGMP TrainingEquipment Log Book, Status Tags, and Room Clearance ChecklistsValidation FilesVALIDATION SCHEDULEDRAWINGS FOR ABC PHARMACEUTICAL PLANTIndex