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<ol><li> 1. Marcel Dekker, Inc. New York Basel Good Laboratory Practice Regulations Third Edition, Revised and Expanded edited by Sandy Weinberg Muhlenberg College Allentown, Pennsylvania, U.S.A. Copyright 2002 by Marcel Dekker, Inc. All Rights Reserved. Copyright 2003 Marcel Dekker, Inc. </li><li> 2. Library of Congress Cataloging-in-Publication Data A catalog record for this book is available from the Library of Congress. ISBN: 0-8247-0891-1 This book is printed on acid-free paper. Headquarters Marcel Dekker, Inc. 270 Madison Avenue, New York, NY 10016 tel: 212-696-9000; fax: 212-685-4540 Eastern Hemisphere Distribution Marcel Dekker AG Hutgasse 4, Postfach 812, CH-4001 Basel, Switzerland tel: 41-61-260-6300; fax: 41-61-260-6333 World Wide Web http://www.dekker.com The publisher offers discounts on this book when ordered in bulk quanti- ties. For more information, write to Special Sales/Professional Marketing at the headquarters address above. Copyright 2003 by Marcel Dekker, Inc. All Rights Reserved. Neither this book nor any part may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, microfilming, and recording, or by any information storage and retrieval system, without permission in writing from the publisher. Current printing (last digit): 10 9 8 7 6 5 4 3 2 1 PRINTED IN THE UNITED STATES OF AMERICA Copyright 2003 Marcel Dekker, Inc. </li><li> 3. Preface The Good Laboratory Practices (GLPs) are extremely effec- tive guidelines intended to provide management with a tool for controlling regulated laboratories and to provide regula- tors with a measurement guide for the evaluation of those controlling efforts. Over the past decade the GLPs have survived the test of field scrutiny and have evolved into a meaningful set of standards for a variety of laboratories worldwide. The effects of evolution on regulation are generally posi- tive. Vague requirements are clarified with example, dispute resolution, and dissemination of interpretation. Differences of opinion are debated, discussed, and synthesized. Guide- lines are issued, investigators are trained, and examples are provided. Working in conjunction with this delineation of regula- tion are the variances created by changes in practice, technol- ogy, and focus. The conjunction of these forces may create its own conflict, but experience and time have a soothing influ- ence even on disagreement; positions and opinions may be at variance, but they are at least clear and specific. Copyright 2003 Marcel Dekker, Inc. </li><li> 4. The GLP regulations have reached this next stage of evolved understanding. The requirements are clear, the guidelines and interpretations are available, and the conflicts are resolved. Even the revolutionary influences of computer- ization in the laboratory have been measured and considered, providing the good automated laboratory practices corollary guidelines. The GLPs have come of age, and provide a clear and consistent framework for the assurance of quality and control in the laboratory. This maturity has led to global GLPs that are, if not identical, at least compatible. In the United States, the same general guidelines apply to laboratories regulated by the Food and Drug Administration (FDA), Environmental Protec- tion Agency (EPA) labs, and general analytical laboratories. Those same standards are consistent with required proce- dures in the European Community (EC); Switzerland, Japan, Israel, Brazil, and Russia. The Worldwide concern for quality and control had evolved the same general principles of opera- tion and organization. This third edition of Good Laboratory Practice Regula- tions reflects that evolutionary maturity of requirements. With a relative uniformity of interpretation more specific and applied information can be provided, furnishing the reader with both the theoretical overview necessary to an- ticipate new and emerging interpretations and the detail of practical information that can serve as a guide to the cur- rent standards and requirements of good laboratory manage- ment. Chapter 1 provides a historical review of the evolution- ary process, tracing the problems and concerns of regulators and the response of laboratory managers to those issues. The ultimate result, is the series of guidelines published as the GLPs, provided with a context and rationale. Chapter 2 provides a definitive review of the current ver- sion of FDA GLPs, including an analysis and interpretation of the enforcement of the GLPs. This summary is an excellent Copyright 2003 Marcel Dekker, Inc. </li><li> 5. overview for readers not previously familiar with the require- ments. Chapter 3 examines the new FDA regulation, Part 11, and its impact on a GLP laboratory setting. This chapter ar- gues that Part 11 is a de facto extension of the GLPs and represents a historical update of the GLP regulation. Chapters 4 and 5 focus on two important applications of the GLPs. In Chapter 4 the GLPs are applied to an auto- mated laboratory as the (EPA) good automated laboratory practices. Chapter 5 examines the impact and interpretation of the GLPs in a non-GLP analytical laboratory. Stephanie Olexa makes an impressive case that the GLPs are relevant guidelines even where they are not regulatory requirements. Chapter 6 provides specific standards and general guide- lines for the validation of Laboratory Information Manage- ment Systems (LIMS) and other computerized laboratory sys- tems. The chapter includes specific interpretations of the validation requirements in the post-Part 11 environment. A review of standards without an examination of the in- terpretation and enforcement of those standards would be of little value. In Chapter 7 therefore, the FDAs GLP inspec- tion program is dissected and analyzed, revealing the philos- ophy and approach of the regulators to GLP field interpreta- tion. In each previous edition the eighth and final chapter has been dedicated to the art of prediction, providing an extrapo- lation of GLP trends and applications into the near-term fu- ture. These predictions have provided gratifyingly accurate recommendations for anticipating new regulatory and practi- cal changes. In this third edition, Chapter 8 looks at the next step in laboratory automation: robotic control of samples and analysis, the field laboratory, new laboratory applications in DNA and other genetic testing, and emerging new govern- ment perspectives on regulation and enforcement. These eight chapters provide a detailed review of the GLP requirements, an examination of the application of Copyright 2003 Marcel Dekker, Inc. </li><li> 6. those requirements, an interpretation of the effects of GLPs on an automated laboratory and the effects of that automa- tion on the GLP guidelines, and a look at future trends in laboratories and their regulation. Sandy Weinberg Copyright 2003 Marcel Dekker, Inc. </li><li> 7. Contents Preface Contributors 1. Historical Perspective Jean M. Taylor and Gary C. Stein 2. FDA/GLP Regulations Wendell A. Peterson 3. Applying 21 CFR Part 11 to the Laboratory Environment Sandy Weinberg 4. The Good Automated Laboratory Practices Gerald J. Whartenby, Paul L. Robinson, and Sandy Weinberg 5. Implementing GLPs in a Non-GLP Analytical Laboratory Stephanie A. Olexa Copyright 2003 Marcel Dekker, Inc. </li><li> 8. 6. Computer Systems Validation Sandy Weinberg 7. The FDAs GLP Inspection Program George W. James 8. The Future Sandy Weinberg Bibliography Copyright 2003 Marcel Dekker, Inc. </li><li> 9. Contributors George W. James U.S. Food and Drug Administration, Rockville, Maryland, U.S.A. Stephanie A. Olexa Benchmark Analytics, Center Valley, Pennsylvania, U.S.A. Wendell A. Peterson Parke-Davis Pharmaceutical Re- search Division of Warner-Lambert Company, Ann Arbor, Michigan, U.S.A. Paul L. Robinson Muhlenberg College, Allentown, Penn- sylvania, U.S.A. Gary C. Stein Weinberg, Spelton &amp; Sax, Inc., Boothwyn, Pennsylvania, U.S.A. Jean M. Taylor* U.S. Food and Drug Administration, Rockville, Maryland, U.S.A. Copyright 2003 Marcel Dekker, Inc. </li><li> 10. Sandy Weinberg Muhlenberg College, Allentown, Penn- sylvania, U.S.A. Gerald J. Whartenby Muhlenberg College, Allentown, Pennsylvania, U.S.A. Copyright 2003 Marcel Dekker, Inc. </li><li> 11. Bibliography Allinson C. Information systems audit trails in legal proceedings as evidence. Computers Sec 20.5: 409421, 2001. Alter S. 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