Validation of
Pharmaceutical
Trang 4Validation of Pharmaceutical Processes Third Edition Edited by James Agalloco
Agalloco & Associates
Belle Mead, New Jersey, USA
Frederick J Carleton
Carleton Technologies Incorporated
Boynton Beach, Florida, USA
informa
healthcare
Trang 5Informa Healthcare USA, Inc 52 Vanderbilt Avenue New York, NY 10017
© 2008 by Informa Healthcare USA, Inc Informa Healthcare is an Informa business No claim to original U.S Government works
Printed in the United States of America on acid-free paper 10987654321
International Standard Book Number-10: 0-8493-7055-8 (Hardcover) International Standard Book Number-13: 978-0-8493-7055-7 (Hardcover)
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identification and explanation without intent to infringe Library of Congress Cataloging-in-Publication Data Validation of pharmaceutical processes / edited by James P Agalloco, Frederick J Carleton - 3rd ed p.;em
Includes bibliographical references and index ISBN-13: 978-0-8493-7055-7 (hardcover : alk paper) ISBN-10: 0-8493-7055-8 (hardcover : alk paper) 1 Sterilization
2 Pharmaceutical technology-Quality control 3 Pharmaceutical technology-Standards
I Agalloco, James P,, 1948- I Carleton, Frederick J., 1925-
Trang 6The complexities of developing this third volume on validation involved a dependence on many sources We were helped and encouraged by a great many people who listened to our ideas
and gave us the benefits of their thoughts Foremost among these were our wives,
Helen Carleton and Linda Agalloco, as well as our children,
Brant and Penny Carleton, and Stephen, Andrea, and Adam Agalloco,
who, throughout these many years of preparation, encouraged us, propelled us to think more aggressively, played devil’s advocate, and considered ideas and topics with us
Most of all, we are grateful for their love and understanding
We do wish especially to thank Drs Sol Motola, Clarence Kemper, Mark Litchman,
Trang 8Preface
We are excited to introduce the third edition of Validation of Pharmaceutical
Processes
With the goal of ensuring pharmaceutical quality of the final manufactured product, the editors have introduced to the industry a subject so extensive that it impacts on good manufacturing practices, research and development, quality assurance, and facility design Validation inevitably leads to process optimization, increased productivity, and lower costs in man-time and manufacturing
The objective of the third edition is to encompass the changes that have taken place in the pharmaceutical industry during the past several years George Bernard Shaw once wrote that “science is always simple and always profound It is only the half-truths that are dangerous.”
The first and second editions of Validation of Pharmaceutical Processes, which
filled the void of both aseptic and non-aseptic processes, are classics in the field of validation The editors continue to build on the success of the previous books with significant updating of this third edition with information that must be made available in current practices This new edition serves as a guide to validation methodologies for the preparation of all pharmaceutical products
This edition now includes practices on managing validation in multinational and small companies, and regulations and validation discussions relative to the interpretation in the Code of Federal Regulations 21 Process analytical tech- nology, real-time monitoring, practitioner compounding and European and Japanese approaches to validation are explored The fundamental concepts of validation are explicitly discussed including calibration and metrology, tempera-
ture measurements, validation of water systems, as well as qualification and
significant aspects of change control
Introducing organization to validation, the editors bring to practitioners the fundamentals of those processes which deal with the microbiology of sterilization, validation of air systems, validation of all heat sterilization processes including
steam, terminal, and dry heat sterilization Detailed sterilization processes
are described for the validation of products employing ethylene oxide, chlorine and radiation processes, each in separate chapters Statistical analysis as well as Six Sigma reviews are examined at length Since the preparation of pharmaceutical products requires distinct process steps, the authors and editors identify critical process control points to reach acceptable results The fundamentals of validation are brought into full view for the reader
The methods that are developed are guides and are not intended to establish standards The impact of validation on the world pharmaceutical health care business has radically influenced the changes of processing in the past 30 years
The third edition of Validation of Pharmaceutical Processes is a detailed book and is considered a must for the scientist in both industry and academia
Frederick J Carleton
Trang 10Contents Preface 0 Contributors xi List of Abbreviations xiii SECTION I INTRODUCTION 1 Why Validation? 7 James Agalloco 2 Organizing for Validation 5 Ronald J Simko 3 Validation and Facility Design 17 J Robert Adamson
SECTION Il SUPPORT AND UTILITY SYSTEMS
4, Validation of Environmental Control Systems Used in Parenteral Facilities 27 Franco De Vecchi 5 Validation of Critical Utilities 51 David W Maynard 6 The Validation of Pharmaceutical Water Systems 59 Theodore H Meltzer 7 Calibration and Metrology 99 Géran Bringert 8 Temperature Measurements 109 Clarence Kemper and Géran Bringert 9 Qualification and Change Control 129
Steven Ostrove
SECTION III STERILIZATION, SANITIZATION, AND STERILITY ASSURANCE
10 Microbiology of Sterilization Processes 147 Roger Dabbah and David A Porter
11 ED,andz Values 159 John Shirtz
12 Steam Sterilization in Autoclaves 175 Phil DeSantis
13 Validation of Terminal Sterilization 187 Thomas J Berger and Kevin D Trupp
14 Steam Sterilization-in-Place Technology and Validation 201 James Agalloco
15 Dry Heat Sterilization and Depyrogenation Validation and Monitoring 223 Laurie B Case and Gayle D Heffernan
16 Validation of Ethylene Oxide Sterilization Processes 241 John R Gillis and Gregg Mosley
17 Validation of Chlorine Dioxide Sterilization 263 Mark A Czarneski and Paul Lorcheim