Handbook of Validation in Pharmaceutical Processes, Fourth Edition  book cover
4th Edition

Handbook of Validation in Pharmaceutical Processes, Fourth Edition

ISBN 9780367754297
Published October 29, 2021 by CRC Press
1061 Pages 230 B/W Illustrations

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Book Description

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

Table of Contents

1. Why Validation?, 2. Facility Design for Validation, 3. Modular Facilities – Meeting the Need for Flexibility, 4. Commissioning and Qualification, 5. Design & Quaification of Controlled Environments, 6. Validation of Pharmaceutical Water Systems, 7. Validation of Critical Utilities, 8. Calibration and Metrology, 9. Risk Management and Thermal Validation, 10. Change Control, 11. MICROBIOLOGY OF STERILIZATION PROCESSES, 12. Biological Indicators, 13. Steam Sterilization in Autoclaves, 14. Validation of Terminal Sterilization, 15. Steam Sterilization-in-Place Technology and Validation, 16. Dry Heat Sterilization, 17. Depyrogenation by Inactivation and Removal, 18. Ethylene Oxide Sterilization, 19. Validation of chlorine dioxide Sterilization, 20. Liquid Phase Sterilization, 21. Vapor Sterilization and Decontamination, 22. Validation of the Radiation Sterilization of Pharmaceuticals, 23. Validation of Sterilizing Grade Filters, 24. Disinfecting Agents: The Art of Disinfection, 25. Cleaning and Disinfecting Laminar Flow Workstations, Bio Safety Cabinets and Fume Hoods, 26. Contamination Control for Component Introduction to Classified Areas, 27. Aseptic Processing for Dosage Form Manufacture, 28. Validation of Manual Aseptic Processes, 29. Validation of Aseptic Processing for Bulk Pharmaceutical Chemicals, 30. Qualification and Validation of Advanced Aseptic Processing Technologies, 31. Total Particle Monitoring, 32. Environmental Monitoring, 33. Validation of Container Component Preparation, 34. Validation of Lyophilization, 35. Validation of Packaging Processes for Sterile Products, 36. Validation of Active Pharmaceutical Ingredients, 37. Cell Culture Process Validation including Cell Bank Qualification, 38. Validation of Recovery and Purification Processes, 39. Validation of Process Chromatography, 40. Single Use Technologies and Systems, 41. Considerations for Process Validation for Cell and Gene Therapies, 42. Validation of Solid Dosage Forms, 43. Validation of Validation of Oral / Topical Liquids & Semi-Solids, 44. Validation of Non-Sterile Packaging Operations, 45. Validation of Cleaning Processes, 46. Validation of Training, 47. Vendor Qualification and Validation, 48. Validation of Clinical Trial Manufacturing, 49. Validation of New Products, 50. Retrospective / Continuous Process Validation, 51. Validation & 6 Sigma, 52. Validation and Contract Manufacturing, 53. Computerized Systems Validation, 54. Risk Based Validation of Laboratory Information Management Systems, 55. Control Systems Validation, 56. Process Analytical Technology and Validation, 57. Validation of Analytical Procedures and Physical Methods, 58. Validation of Microbial Methods, 59. "Rapid Methods for Aseptic Processing and Their Validation", 60. Extractables and Leachables in Drug Products: An Overview, 61. Evolution and Implementation of Validation in the United States, 62. Validation in Europe - What are the Differences?, 63. Japanese Approach to Validation, 64. Organization of Validation in a MultiNational Pharmaceutical Company, 65. Validation in a Small Pharmaceutical Company, 66. Regulatory Aspects of Process Validation in the United States, 67. The Future of Validation

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James Agalloco is President of Agalloco & Associates, a technical service firm to the pharmaceutical and biotechnology industry. He was previously Director, Worldwide Validation and Automated Technology for Bristol-Myers Squibb. He received his BS in Chemical Engineering from Pratt Institute in 1968 and his MS, also in Chemical Engineering from Polytechnic Institute of New York in 1979. He received his MBA in Pharmaceutical Studies from Fairleigh Dickinson University in 1983. He is a past President of the Parenteral Drug Association and served as an Officer or Director from 1982 to 1993. He is a member of USP’s Microbiology and Sterility Assurance Expert Committee for 2005-2015. He is a frequent author and lecturer on sterilization, aseptic processing and process validation.


This revised and updated fourth edition provides a comprehensive overview of
validation methodologies applicable in the manufacturing process of various
pharmaceuticals. This reference may be viewed as a guide to developing rational
control processes to ensure the quality of pharmaceutical products. This
edition includes new topics related to biologics and single-use technologies.

This book aims to offer a comprehensive guide to developing and controlling
pharmaceutical manufacturing processes to ensure the safety and quality of the
products. For the past several years, the FDA has been promoting the concept of
Quality by Design (QBD) to manufacture safe and effective drug products.
Validation refers to the essential controls or evidence-based documented
processes that consistently provide a high degree of quality assurance of
manufacturing quality products. This reference provides a theoretical and
practical basis for consistently establishing processes to produce products
with predetermined specifications. Therefore, the objectives of this book are
valuable to pharmaceutical industry professionals.

According to the authors, this reference would be helpful to all "industry
professionals." This reference is a valuable guide to individuals concerned
about the process validation in pharmaceutical manufacturing. Similar to the
previous editions, this fourth edition is expected to be well utilized by the
professionals working in process validation. The authors are reputable industry
professionals. The contributors are primarily from the industry with relevant

This book should be considered as a reference guide to pharmaceutical process
validation. In 67 chapters, this reference presents content related to the
conceptual framework and the practical aspects of developing and controlling
pharmaceutical processes to ensure product quality. The fundamental aspects of
pharmaceutical process validation have been expanded from the previous edition.
A few new chapters have been added. The new topics include gene therapy and
single-use technologies. The new chapters on process validation of combination
products, nanotechnology, disposable system, and medical device manufacturing
are expected to be informative and valuable to industry professionals. The
authors' years of industry experience have helped them discuss the challenges
and opportunities in various stages of a validation program. The authors'
insight into the solutions for possible challenges in process validation is
expected to be helpful to the target audience. The chapter on process
validation for cell and gene therapies succinctly provides insight into the
complexity of and current trends in process validation of biotechnology-based
products. The interested audience will well utilize the information to make
strategic decisions about the validation of bioprocessing. The reference
provides discussions on Six Sigma approaches toward process validation. In
addition, discussions on Process Analytical Technology and Validation and
Computerized Systems Validation are practical from the industry perspective.
The authors have shared their perspectives on the future of validation in a
short chapter, which readers are expected to find interesting. There are three
chapters on approaches to validation in the United States, Europe, and Japan.
People working in multinational pharmaceutical companies should find those
chapters handy. The authors have provided sufficient flow charts and diagrams
to facilitate understanding. The reference has become voluminous to include
relevant topics. Therefore, it could be developed in two or three volumes. Some
of the image quality could be improved.

This reference provides theoretical and practical considerations in identifying
critical process control issues related to the manufacturing of
pharmaceuticals. This fourth edition has a few new topics related to emerging
trends in pharmaceutical preparations. Pharmaceutical scientists,
manufacturers, engineers, drug quality assurance and regulatory personnel,
project and program managers, and information system professionals are expected
to benefit from this reference. A few books are available related to this
subject matter, but they are not as comprehensive as this one. This book will
serve its purpose as a reference guide. New chapters have enriched this fourth

- Rahmat M. Talukder, PhD, RPh (The University of Texas at Tyler)