Title: Handbook of Validation in Pharmaceutical Processes, 4th Edition Author: Anthony Grilli, Anthony Pavell, James Agalloco, Phil DeSantis ISBN: 0367754290 / 9780367754297 Format: Hard Cover Pages: 1061 Publisher: CRC Press Year: 2021 Availability: 2 to 3 weeks
Description
Contents
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