Tab Article

Preface

Chapter 1 : Why Validation?
Chapter 2 : Facility Design for Validation
Chapter 3 : Modular Facilities - Meeting the Need for Flexibility
Chapter 4 : Commissioning and Qualification
Chapter 5 : Design & Quaification of Controlled Environments
Chapter 6 : Validation of Pharmaceutical Water Systems
Chapter 7 : Validation of Critical Utilities
Chapter 8 : Calibration and Metrology
Chapter 9 : Risk Management and Thermal Validation
Chapter 10 : Change Control
Chapter 11 : Microbiology of Sterilization Processes
Chapter 12 : Biological Indicators
Chapter 13 : Steam Sterilization in Autoclaves
Chapter 14 : Validation of Terminal Sterilization
Chapter 15 : Steam Sterilization-in-Place Technology and Validation
Chapter 16 : Dry Heat Sterilization
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 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 Component Introduction to Classified Areas
Chapter 27 : Aseptic Processing for Dosage Form Manufacture
Chapter 28 : Validation of Manual Aseptic Processes
Chapter 29 : Validation of Aseptic Processing for Bulk Pharmaceutical Chemicals
Chapter 30 : Qualification and Validation of Advanced Aseptic Processing Technologies
Chapter 31 : Total Particle  Monitoring
Chapter 32 : Environmental Monitoring
Chapter 33 : Validation of Container Component Preparation
Chapter 34 : Validation of Lyophilization
Chapter 35 : Validation of Packaging Processes for Sterile Products
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 Forms
Chapter 43 : Validation of Validation of Oral / Topical Liquids & Semi-Solids
Chapter 44 : Validation of Non-Sterile Packaging Operations
Chapter 45 : Validation of Cleaning Processes
Chapter 46 : Validation of Training
Chapter 47 : Vendor Qualification and Validation
Chapter 48 : Validation of Clinical Trial Manufacturing
Chapter 49 : Validation of New Products
Chapter 50 : Retrospective / Continuous Process Validation
Chapter 51 : Validation & 6 Sigma
Chapter 52 : Validation and Contract Manufacturing
Chapter 53 : Computerized Systems Validation
Chapter 54 : Risk Based Validation of Laboratory Information Management Systems
Chapter 55 : Control Systems Validation
Chapter 56 : Process Analytical Technology and Validation
Chapter 57 : Validation of Analytical Procedures and Physical Methods
Chapter 58 : Validation of Microbial Methods
Chapter 59 : "Rapid Methods for Aseptic 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 Europe - What 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