Cover
Half Title
Title Page
Copyright Page
Contents
About the Editors
Contributors
Preface to the Fourth Edition
Fourth Edition History
Chapter 1 Why Validation?
Chapter 2 Facility Design for Validation
Chapter 3 Modular FacilitiesโMeeting the Need for Flexibility
Chapter 4 Commissioning and Qualification
Chapter 5 Design and Qualification of Controlled Environments
Chapter 6 Validation of Pharmaceutical Water Systems
Chapter 7 Validation of Critical Utilities
Chapter 8 Calibration and Metrology
Chapter 9 Temperature Measurements
Chapter 10 Change Control
Chapter 11 Microbiology of Sterilization Processes
Chapter 12 Biological Indicators for Sterilization
Chapter 13 Steam Sterilization in Autoclaves
Chapter 14 Validation of Terminal Sterilization
Chapter 15 Steam Sterilization-in-Place
Chapter 16 Validation of Dry Heat Sterilization and Depyrogenation
Chapter 17 Depyrogenation by Inactivation and Removal
Chapter 18 Ethylene Oxide Sterilization
Chapter 19 Validation of Chlorine Dioxide Sterilization
Chapter 20 Liquid Phase Sterilization
Chapter 21 Vapor Phase Sterilization and Decontamination
Chapter 22 Validation of the Radiation Sterilization of Pharmaceuticals
Chapter 23 Validation of Sterilizing-Grade Filters
Chapter 24 Disinfecting Agents: The Art of Disinfection
Chapter 25 Cleaning and Disinfecting Laminar Flow Workstations, Bio Safety Cabinets, and Fume Hoods
Chapter 26 Contamination Control for Incoming Components to Classified Areas: โWar at the Doorยฎโ
Chapter 27 Aseptic Processing of Sterile Dosage Forms
Chapter 28 Manual Aseptic Processes
Chapter 29 Aseptic Processing for Sterile Bulk Pharmaceutical Chemicals
Chapter 30 Qualification and Validation of Advanced Aseptic Processing Technologies
Chapter 31 Total Particle Counts
Chapter 32 Environmental Monitoring
Chapter 33 Validation of Container Preparation Processes
Chapter 34 Validation of Lyophilization
Chapter 35 Validation of Sterile Drug Product Packaging Processes
Chapter 36 Validation of Active Pharmaceutical Ingredients
Chapter 37 Cell Culture Process Validation Including Cell Bank Qualification
Chapter 38 Validation of Recovery and Purification Processes
Chapter 39 Validation of Process Chromatography
Chapter 40 Single-Use Technologies and Systems
Chapter 41 Considerations for Process Validation for Cell and Gene Therapies
Chapter 42 Validation of Solid Dosage Finished Goods
Chapter 43 Validation of Oral/Topical Liquids and Semi-Solids
Chapter 44 Validation of Non-Sterile Packaging Operations
Chapter 45 Cleaning Validation for the Pharmaceutical, Biopharmaceutical, Cosmetic, Nutraceutical, Medical Device and Diagnostic Industries
Chapter 46 Validation of Training
Chapter 47 Vendor Qualification and Validation
Chapter 48 Validation for Clinical Manufacturing
Chapter 49 Validation of New Products
Chapter 50 Retrospective Validation
Chapter 51 Validation and Six Sigma
Chapter 52 Validation and Contract Manufacturing
Chapter 53 Computerized Systems Validation
Chapter 54 Risk Based Validation of a Laboratory Information Management System (LIMS)
Chapter 55 Control Systems Validation
Chapter 56 Process Analytical Technology (PAT): Understanding Validity of Pharmaceutical Quality Control and Assurance
Chapter 57 Validation of Analytical Procedures and Physical Methods
Chapter 58 Validation of Microbiological Methods
Chapter 59 Rapid Methods for Pharmaceutical Processing and Their Validation
Chapter 60 Extractables and Leachables in Drug Products: An Overview
Chapter 61 Evolution and Implementation of Validation in the United States
Chapter 62 Validation in EuropeโWhat Are the Differences?
Chapter 63 Japanese Approach to Validation
Chapter 64 Organization of Validation in a Multinational Pharmaceutical Company
Chapter 65 Validation in a Small Pharmaceutical Company
Chapter 66 Regulatory Aspects of Process Validation in the United States
Chapter 67 The Future of Validation
Index
