RISK MANAGEMENT APPLICATIONS IN PHARMACEUTICAL AND BIOPHARMACEUTICAL MANUFACTURING

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3 RISK MANAGEMENT APPLICATIONS IN PHARMACEUTICAL AND BIOPHARMACEUTICAL MANUFACTURING

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5 RISK MANAGEMENT APPLICATIONS IN PHARMACEUTICAL AND BIOPHARMACEUTICAL MANUFACTURING Edited by A. HAMID MOLLAH MIKE LONG HAROLD S. BASEMAN A JOHN WILEY & SONS, INC., PUBLICATION

6 Copyright 2013 by John Wiley & Sons, Inc. All rights reserved Published by John Wiley & Sons, Inc., Hoboken, New Jersey Published simultaneously in Canada No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording, scanning, or otherwise, except as permitted under Section 107 or 108 of the 1976 United States Copyright Act, without either the prior written permission of the Publisher, or authorization through payment of the appropriate per-copy fee to the Copyright Clearance Center, Inc., 222 Rosewood Drive, Danvers, MA 01923, (978) , fax (978) , or on the web at Requests to the Publisher for permission should be addressed to the Permissions Department, John Wiley & Sons, Inc., 111 River Street, Hoboken, NJ 07030, (201) , fax (201) , or online at Limit of Liability/Disclaimer of Warranty: While the publisher and author have used their best efforts in preparing this book, they make no representations or warranties with respect to the accuracy or completeness of the contents of this book and specifically disclaim any implied warranties of merchantability or fitness for a particular purpose. No warranty may be created or extended by sales representatives or written sales materials. The advice and strategies contained herein may not be suitable for your situation. You should consult with a professional where appropriate. Neither the publisher nor author shall be liable for any loss of profit or any other commercial damages, including but not limited to special, incidental, consequential, or other damages. For general information on our other products and services or for technical support, please contact our Customer Care Department within the United States at (800) , outside the United States at (317) or fax (317) Wiley also publishes its books in a variety of electronic formats. Some content that appears in print may not be available in electronic formats. For more information about Wiley products, visit our web site at Library of Congress Cataloging-in-Publication Data is available. Printed in the United States of America ISBN:

7 CONTENTS Preface Contributors About the Authors vii xi xiii 1 Background and Introduction 1 Harold S. Baseman and A. Hamid Mollah 2 Risk Management Tools 17 Mark Walker and Thomas Busmann 3 Risk Management: Regulatory Expectation, Risk Perception, and Organizational Integration 49 Mike Long 4 Statistical Topics and Analysis in Risk Assessment 75 Mike Long 5 Quality by Design 89 Bruce S. Davis 6 Process Development and Clinical Product Manufacturing 101 Karen S. Ginsbury v

8 vi CONTENTS 7 Points to Consider for Commissioning and Qualification of Manufacturing Facilities and Equipment 129 Harold S. Baseman and Michael Bogan 8 Process Lifecycle Validation 179 A. Hamid Mollah and Scott Bozzone 9 Aseptic Processing: One 227 James P. Agalloco and James E. Akers 10 Aseptic Processing: Two 243 Edward C. Tidswell 11 Pharmaceutical Product Manufacturing 275 Marlene Raschiatore 12 Biopharmaceutical Manufacturing 325 Ruhi Ahmed and Thomas Genova 13 Risk-Based Change Control 367 William Harclerode, Bob Moser, Jorge A. Ferreira, and Christophe Noualhac Index 387

9 PREFACE With the introduction of FDA s 21st century GMP and ICH initiatives (such as Q8 Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System), drug manufacturing entered a new era of risk management. Although regulatory agencies are encouraging the use of risk management in pharmaceutical and biopharmaceutical product manufacturing, regulatory guidance and comprehensive literature on how to use and implement risk management is limited and in need of further development. This book will fill this large void and assist both industry as well as agency to implement a compliant and effective risk management approach. The book has been prepared to provide the readers with some points to consider for managing risks to product quality incurred during the manufacture of biopharmaceutical and pharmaceutical products, including Industry trend towards to use of QRM for manufacturing control Regulatory expectations Use of limited resources and cost control Maintaining and assuring product quality Process and quality improvement Over the years, the authors and editors of this book have presented to and met with numerous people at many companies, plants, and organizations in the pharmaceutical industry, asking about and providing instruction in quality risk management. While audiences have generally become more aware of the topic, including the expectation and perhaps even the benefit of its use, it has not been clear whether the aspects of its implementation have been fully appreciated and vii

10 viii PREFACE taken advantage of. We saw many instances where resources and time were spent to complete hundreds of risk assessments, but never utilized into manufacturing operations. Identification of risk without action has minimal benefit and can be viewed as shifting a company from ignorance to avoidance. This has led the editors of this book to believe that there was a strong need for further explanation and education on approaches for the practical implementation of quality risk management for pharmaceutical and biopharmaceutical processes. Over the past half-decade or more, companies and individuals have explored, developed, implemented, benefited, and refined methods for risk management, assessment, review, and decision making that utilize approaches, models, systems, techniques, schemes and plans some more effective, some less. This book creates this link by exploring risk management of manufacturing processes through a collection of chapters written by some of the leading experts in pharmaceutical and biopharmaceutical product manufacturing. The editors chose topics that represented the most significant challenges in the industry at the time of writing. The ultimate goal of the risk management process is to bring focus and effort to the issues in an organization that imparts the highest risk to product quality and/or patient safety. The degree of formality and rigor applied should be commensurate with the complexity and/or criticality of the element or issue. There are many tools that can be applied, which are new to many in the industry. For risk assessors, there can be confusion with the level and detail of an assessment as well as the potential subjectivity, which can permeate an assessment. These issues are compounded with the uncertainty of the regulatory framework and application of risk. Hence, it is quite important to use proven and compliant risk management approaches to assure acceptable results. This book was written by authors who have used risk management to improve processes, investigate failures, design operations, validate processes, and increase overall quality and productivity of their respective operations. This book is not a collection of history or fundamentals, nor is it a book of theoretical desired states. Although the book does explore and present some background and introduction, it is primarily focused on the practical presentation of points to consider and methods to help the reader make better decisions based on risk and to help manage that risk. This book is written by people who lived through the introduction of this topic to our industry and participated in its implementation. Our authors want to communicate best practices to help the reader better implement and benefit from its use without experiencing the unnecessary burden and redundancies that often accompany activities in this industry. This book provides examples of risk management in areas from the process development to sterile fill operations. Risk management should be a method for making our jobs more doable, adding to our understanding of processes, and helping us make better decisions. It should not be just a checklist item, another corporate directive, of little value. To the contrary, the objective of this book is to help the reader understand, appreciate, use, and benefit from risk management. We hope you will find it useful and enjoyable.

11 PREFACE ix We express our gratitude to all the authors for contributing to this book. Thanks to Anurag Rathore for his encouragement and persuasion to complete this book. We also thank Lynn Torbeck at Torbeck and Association, Kevin O Donnel at the IMB (Irish Medicines Board), Emma Ramnarine and David Reifsnyder at Genentech, Penny Butterell and Simon Smith at Pfizer, and Brian Turley and Walter Henkels at Valsource for providing feedback. Thank you, The Editors

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13 CONTRIBUTORS James P. Agalloco, Agalloco & Associates, Belle Mead, NJ Ruhi Ahmed, Regulatory Affairs, Ultragenyx, Novato, CA James E. Akers, Akers Kennedy & Associates, Kansas City, MO Harold S. Baseman, ValSource LLC, Jupiter, FL Michael Bogan, Integrated Commissioning & Qualification, LLC, Hope Valley, RI Scott Bozzone, Pfizer Inc., Peapack, NJ Thomas Busmann, Focus Compliance & Validation Services, Knoxville, TN Bruce S. Davis, Bruce Davis (Global Consulting), Haslemere, Surrey, UK Jorge A. Ferreira, Jacobs Engineering Group, Conshohocken, PA Thomas Genova, Johnson & Johnson, Raritan, NJ Karen S. Ginsbury, PCI Pharmaceutical Consulting Israel, Petach Tikvah, Israel A. Hamid Mollah, Quality Engineering and Validation, XOMA Corporation, Berkeley, CA William Harclerode, Forest Labs, Harborside Financial Center, Jersey City, NJ Mike Long, ConcordiaValSource, Wayland, MA Bob Moser, Jacobs Engineering, Conshohocken, PA xi

14 xii CONTRIBUTORS Christophe Noualhac, Product Development, Halo Pharmaceutical, Whippany, NJ Marlene Raschiatore, Johnson & Johnson, Glen Mills, PA Edward C. Tidswell, Baxter Healthcare Corp, Sterility Assurance Department, Round Lake, IL Mark Walker, Focus Compliance & Validation Services, Knoxville, TN

15 ABOUT THE AUTHORS James Agalloco, President, Agalloco & Associates, is a pharmaceutical manufacturing expert with more than 40 years of experience. He worked in organic synthesis, pharmaceutical formulation, pharmaceutical production, project/process engineering, and validation during his career at Merck, Pfizer, and Bristol-Myers Squibb. Since the formation of A&A in 1991, Jim has assisted more than 100 firms with validation, sterilization, aseptic processing, and compliance. He has edited/coedited four texts, authored/coauthored more than 40 chapters, published more than 100 papers, and lectured extensively on numerous subjects. He is a past president of the Parenteral Drug Association (PDA), a current member of USP s Microbiology Expert Committee, the Editorial Advisory Board for Pharmaceutical Technology and Pharmaceutical Manufacturing. Ruhi Ahmed is currently the Senior Director in the Regulatory Affairs department at Ultragenyx Pharmaceutical, Inc. She has previously worked in the Regulatory Affairs at Watson Pharmaceuticals and BioMarin Pharmaceutical Inc. Dr. Ahmed graduated in 2003 from the University of Southern California (USC) with a PhD in Molecular Pharmacology and Toxicology. She also has an MS degree in Regulatory Science from the USC and an MA degree in Biochemistry from the University of Texas at Austin. Dr. Ahmed has earned her RAC certification for both the European Union and the United States. As a member of PDA s Task Force on Quality Risk Management, Dr. Ahmed has participated in coauthoring PDA Technical Report #44 on Quality Risk Management for Aseptic Processes. She is currently leading a PDA Task Force on assessing general applications of Quality Risk Management for Biopharmaceutical APIs. James E. Akers, PhD, is the President of Akers Kennedy & Associates, Inc., located in Kansas City, Missouri. Dr. Akers has over 25 years experience in the xiii