图书简介
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
Chapter 1 Why Validation? James Agalloco Chapter 2 Facility Design for Validation Phil DeSantis Chapter 3 Modular Facilities - Meeting the Need for Flexibility Maik Jornitz and Sidney Backstrom Chapter 4 Commissioning and Qualification Phil DeSantis and S. Osgrove Chapter 5 Design & Quaification of Controlled Environments Franco De Vecchi and Phil DeSantis Chapter 6 Validation of Pharmaceutical Water Systems William V. Collentro Chapter 7 Validation of Critical Utilities David W. Maynard Chapter 8 Calibration and Metrology Goran Bringert Chapter 9 Risk Management and Thermal Validation Goran Bringert Chapter 10 Change Control S. Osgrove and Phil DeSantis Chapter 11 MICROBIOLOGY OF STERILIZATION PROCESSES John Shirtz Chapter 12 Biological Indicators Hurt McCauley and Nicole Robichaud Chapter 13 Steam Sterilization in Autoclaves Phil DeSantis Chapter 14 Validation of Terminal Sterilization Kevin D. Trupp and Thomas J. Berger Chapter 15 Steam Sterilization-in-Place Technology and Validation James Agalloco Chapter 16 Dry Heat Sterilization George Schaeffer and Kishore Warrier Chapter 17 Depyrogenation by Inactivation and Removal Karen Zink McCullough and Allen Burgenson Chapter 18 Ethylene Oxide Sterilization James Agalloco Chapter 19 Validation of chlorine dioxide Sterilization Mark A. Czarneski and Paul Lorcheim Chapter 20 Liquid Phase Sterilization James Agalloco Chapter 21 Vapor Sterilization and Decontamination James Agalloco Chapter 22 Validation of the Radiation Sterilization of Pharmaceuticals Geoffrey P. Jacobs Chapter 23 Validation of Sterilizing Grade Filters Suraj B. Baloda Chapter 24 Disinfecting Agents: The Art of Disinfection Arthur Vellutato Jr Chapter 25 Cleaning and Disinfecting Laminar Flow Workstations, Bio Safety Cabinets and Fume Hoods Arthur Vellutato Jr Chapter 26 Contamination Control for Component Introduction to Classified Areas Arthur Vellutato Jr Chapter 27 Aseptic Processing for Dosage Form Manufacture James Agalloco & James Akers Chapter 28 Validation of Manual Aseptic Processes James Agalloco & James Akers Chapter 29 Validation of Aseptic Processing for Bulk Pharmaceutical Chemicals James Agalloco and Phil DeSantis Chapter 30 Qualification and Validation of Advanced Aseptic Processing Technologies James Agalloco & James Akers Chapter 31 Total Particle Monitoring Mark Hallworth Chapter 32 Environmental Monitoring Jeanne Moldenhauer Chapter 33 Validation of Container Component Preparation William G. Lindboe Chapter 34 Validation of Lyophilization Joseph P. Brower Chapter 35 Validation of Packaging Processes for Sterile Products Charles Levine Chapter 36 Validation of Active Pharmaceutical Ingredients James Agalloco & Phil DeSantis Chapter 37 Cell Culture Process Validation including Cell Bank Qualification Anne B. Tolstrup, Steven I. Max, Denis Drapeau and Timothy S. Charlebois Chapter 38 Validation of Recovery and Purification Processes Frank Riske and Howard L. Levine Chapter 39 Validation of Process Chromatography Gunter Jagschies Chapter 40 Single Use Technologies and Systems A. Mark Trotter and Derek Pendlebury Chapter 41 Considerations for Process Validation for Cell and Gene Therapies Karen Zink McCullough, Anthony Thatcher and Merrick Endejann Chapter 42 Validation of Solid Dosage Forms William G. Lindboe Chapter 43 Validation of Validation of Oral / Topical Liquids & Semi-Solids William G. Lindboe Chapter 44 Validation of Non-Sterile Packaging Operations William G. Lindboe Chapter 45 Validation of Cleaning Processes Rebecca Brewer Chapter 46 Validation of Training Chris Smalley Chapter 47 Vendor Qualification and Validation Maik Jornitz Chapter 48 Validation of Clinical Trial Manufacturing Warren Charlton and Tom Ingallinera Chapter 49 Validation of New Products Norman Elder Chapter 50 Retrospective / Continuous Process Validation Kevin M Jenkins Chapter 51 Validation & 6 Sigma Robert Bottome Chapter 52 Validation and Contract Manufacturing Michael C. Beckloff Chapter 53 Computerized Systems Validation Saeed Tafreshi Chapter 54 Risk Based Validation of Laboratory Information Management Systems RD McDowall and Jeff Eshelman Chapter 55 Control Systems Validation Phil DeSantis and Steven Osgrove Chapter 56 Process Analytical Technology and Validation Ajaz Hussein Chapter 57 Validation of Analytical Procedures and Physical Methods Francis E. Beideman Chapter 58 Validation of Microbial Methods Anthony Grilli Chapter 59 \"Rapid Methods for Aseptic Processing and Their Validation\" Jeanne Moldenhauer Chapter 60 Extractables and Leachables in Drug Products: An Overview Will Parker and Don DeCou Chapter 61 Evolution and Implementation of Validation in the United States James Agalloco and Phil DeSantis Chapter 62 Validation in Europe - What are the Differences? Trevor Deeks Chapter 63 Japanese Approach to Validation Satoshi Sugimoto, Mitsuo Mori, Kiyoshi Mochizuki, Keisuke Nishikawa, Takuji Ikeda, Yusuke Matsuda, Hiroaki Nakamura Chapter 64 Organization of Validation in a MultiNational Pharmaceutical Company Kevin M Jenkins Chapter 65 Validation in a Small Pharmaceutical Company Stephen C. Tarallo Chapter 66 Regulatory Aspects of Process Validation in the United States James Agalloco and Robert Mello Chapter 67 The Future of Validation James Agalloco and Phil DeSantis
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