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

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. Ostrove

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


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         

Günter 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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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.