Handbook of Validation in Pharmaceutical Processes, 4th Edition

Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded work is a comprehensive analysis of all the fundamental elements of pharmaceutical and bio-pharmaceutical production processes. Handbook of Validation in Pharmaceutical Processes, Fourth Edition is essential for all global health care manufacturers and pharmaceutical industry professionals.

Key Features:

• Provides an in-depth discussion of recent advances in sterilization
• Identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions
• Explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results
• New chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture

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