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Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance
Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance
Edición: 1st
Autores: Syed Imtiaz Haider
Editorial:
ISBN: 9781574443301
Formato: Rústica/Paperback
Nº volumenes: 1 Páginas: 176
Año publicación: 2001
Disponibilidad: 15 días
Precio: 183,61 € 174,43 € (181,41€ iva incluído)
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Cómpralos juntos y ahorra
Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance Todo lo que debe saber sobre Marketing Farmacéutico
· Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance (Syed Imtiaz Haider)
· Todo lo que debe saber sobre Marketing Farmacéutico (Juan Carlos Serra)
240,34 € 228,32 €
Descripción/Descrição/
  • Supplies valuable text establishing a master plan in compliance with FDA, GMP, and GLP requirements
  • Provides a missing link between the Validation Master Plan to the Validation Standard Operating Procedures and Protocols developed and executed
  • Furnishes the building blocks for developing validation procedures successfully based on FDA guidelines and enables users to achieve regulatory compliance with time, money, and resource optimization
  • Defines responsibilities and frequencies for revalidation
  • Provides, in text and CD-ROM, a simple, concise and easy-to-use reference tool for the test and validation of new and old pharmaceutical industry products and facilities


  • 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.




    Table of Contents
    INTRODUCTION
    Project Description
    What is a Validation Master Plan
    Scope of a Validation Master Plan
    Definition of the Term Validation
    Validation Team Members
    Validation Team Responsibilities
    CONCEPT OF QUALIFICATION / VALIDATION
    Fundamentals
    Concept of a Validation Life Cycle
    Elements of Qualification/Validation
    Documentation Format of Qualification Programs
    Numbering System
    REVALIDATION
    RESPONSIBILITIES
    FACILITY DESCRIPTION
    Line Capacities
    DESCRIPTION OF BUILDING
    Dry Production Facility: Building A
    Liquid and Semisolid Production Facility: Building B
    Parenterals Production Facility: Building C
    EQUIPMENT DESCRIPTION
    Dry Production Facility: Building A
    Liquid and Semisolid Production Facility: Building B
    Parenterals Production Facility: Building C
    Over- Printing Area
    Quality Control
    Quality Assurance (In-Process)
    Product Development Laboratories
    HVAC DESCRIPTION
    Dry Production Facility: Building A
    Liquid and Semisolid Production Facility: Building B
    Parenterals Production Facility: Building C
    Over-Printing Area
    Quality Control
    Quality Assurance (In-Process)
    Product Development Laboratories
    UTILITIES DESCRIPTION
    Deionized Water (DI Water)
    Purified Water
    Water for Injection (WFI)
    Chilled Water
    Pure Steam
    Compressed Air
    Nitrogen (N2)
    Carbon Dioxide (CO2)
    Electric Power
    Sanitary Water
    HVAC (Heating, Ventilation, and Air Conditioning) System
    VALIDATION PROGRAM OVERVIEW
    Validation Project Management: Organization
    Validation Responsibilities
    Design and Validability Review
    Validation Documents
    Installation Qualification Protocols
    Operational Qualification Protocols
    Change Control Initiation
    Cycle Development
    Performance Qualification Protocols
    Process Validation Protocols
    Validation Final Reports
    Validation Package
    Certificate for Use in Manufacturing
    Required Protocols and Procedures for Dry Production: Building A
    Required Protocols and Procedures for Liquid and Semisolid Production: Building B
    Required Protocols and Procedures for Parenterals Production: Building C
    CALIBRATION PROGRAM SUMMARY
    PREVENTATIVE MAINTENANCE PROGRAM SUMMARY
    KEY STANDARD OPERATING PROCEDURES (SOPS)
    VALIDATION OF BUILDING
    Civil Work
    Drainage System
    VALIDATION OF UTILITY SYSTEMS
    Plant Steam
    Pure Steam
    Water for Injection (WFI)
    Compressed Air
    Nitrogen (N2)
    Heating Ventilation and Air Conditioning (HVAC)
    Emergency Power (Standby Generator)
    PROCESS DESCRIPTION BUILDING A DRY PRODUCTION: BUILDING A
    Process Flow, Variables and Responses: Tablets
    Process Flow, Variables and Responses Powder for Suspension
    Process Flow, Variables and Responses: Capsules
    PROCESS DESCRIPTION LIQUID AND SEMISOLID PRODUCTION: BUILDING B
    Process Flow, Variables, and Responses: Syrup, Suspension, and Drop Products
    Process Flow, Variables and Responses: Cream Ointment, and Suppository Products
    PROCESS DESCRIPTION FOR PARENTERALS PRODUCTION FACILITY: BUILDING C
    Process Flow, Variables, and Responses: Aseptic Fill Products
    Process Flow, Variables, and Responses: Ready-to-Use Disposable Syringes
    Process Flow, Variables, and Responses: Terminal Sterilization Products
    Process Flow, Variables and Responses: Lyophilized Products
    QUALIFICATION OF PROCESS EQUIPMENT
    Commuting Mill
    Dryer
    V-Shell Blender
    Tablet Compression
    Capsulation
    Powder Filing
    Capsule Polisher
    Tablet Coating
    Syrup Manufacturing Vessel
    Suspension Manufacturing Vessel
    Drops Manufacturing Vessel
    Mixer
    Filter Press
    Cream/Ointment/Suppository Manufacturing Vessel
    Syrup, Suspension, and Drop Filling Machine
    Cream and Ointment Filling Machine
    Suppository Filling Machine
    Labeling Machine
    Capping Machine
    Cartonator
    Shrink-Wrapping Machine
    Over-Printing Machine
    Autoclave (Steam Sterilizer)
    Hot Air Tunnel (Dry Heat Sterilizer)
    Vials / Ampoules Washing Machine
    Vials / Ampoules / Syringes Filling Machine
    Freeze Dyer (Lyophilizer)
    Laminar Flow Unit
    Pass Through
    VALIDATION OF SUPPORT PROCESS
    Washing of Components
    Sterilization of Components
    Depyrogenation of Components
    Aseptic Filling Validation (Media Fill Studies)
    Cross-Contamination Control
    Computerized Pharmaceutical System
    QUALITY ASSURANCE / CONTROL LABORATORY VALIDATION
    Laboratory Equipment Qualification
    Computer Related Systems in QA/QC Laboratory
    cGMP PROCEDURES AND PROGRAMS
    Engineering Change Control
    Calibration
    Preventive Maintenance Program
    Standard Operating Procedure (SOPs)
    Facility Cleaning and Sanitization
    Environmental Monitoring Program
    HEPA Filter Integrity Testing
    Filter Integrity Testing
    Label Control Program
    cGMP Training
    Equipment Log Book, Status Tags, and Room Clearance Checklists
    Validation Files
    VALIDATION SCHEDULE
    DRAWINGS FOR ABC PHARMACEUTICAL PLANT
    Index


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