4th Edition
Handbook of Validation in Pharmaceutical Processes, Fourth Edition
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
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
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
Biography
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
experience.
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
edition.
- Rahmat M. Talukder, PhD, RPh (The University of Texas at Tyler)
