A Laboratory Quality Handbook of Best Practices

Description

Based on the work of a collection of experts from the laboratory science and quality assurance fields, A Laboratory Quality Handbook of Best Practices and Relevant Regulations provides all of the information needed to run a successful laboratory that is in compliance with all regulations. From sample tracking to accurate documentation, training to methods validation, maintenance to calibration, and out-of-spec responses to preparation for audits, a combination of people, instrumentation and documentation must work in sync for high quality results. This handbook provides information that will help a laboratory achieve high quality results and compliance. Contents: Quality Assurance in the Laboratory, History of Regulation, Training in the Laboratory, Laboratory Documentation and Data, Sample Control and LIM Systems, Methods Validation

Sujets

• Business
• Qualité, hygiène, sécurité, environnement
• Auditing
• Economie gestion
• risk management
• FMEA
• Economics
• Analyse des modes de défaillance, de leurs effets et de leur criticité

Informations

• Publié par: ASQ Quality Press
• Date de parution: 25 septembre 2001
• Nombre de lectures: 0
• EAN13: 9780873891097
• Langue: English
• Poids de l'ouvrage: 2 Mo

Extrait

A Laboratory Quality Handbook of Best Practices

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To request a complimentary catalog of ASQ Quality Press publications, call 800-248-1946, or visit our online bookstore at http://qualitypress.asq.org .

A Laboratory Quality Handbook of Best Practices

Donald C. Singer, Editor

ASQ Quality Press Milwaukee, Wisconsin

A Laboratory Quality Handbook of Best Practices Edited by Donald C. Singer

Library of Congress Cataloging-in-Publication Data

A laboratory quality handbook of best practices and relevant regulations / edited by Donald C. Singer. p. cm. Includes bibliographical references and index. ISBN 0-87389-491-X (alk. paper) 1. Laboratories—Quality control—Handbooks, manuals, etc.. 2. Laboratories—Law and legislation—Handbooks, manuals, etc. I. Singer, Donald C., 1953– R852.L25 2001 616.07'56'0685—dc21 2001022072 © 2001 by ASQ

All rights reserved. No part of this book may be reproduced in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written permission of the publisher.

10 9 8 7 6 5 4 3 2 1

ISBN 0-87389-490-1

Acquisitions Editor: Annemieke Koudstaal Production Administrator: Gretchen Trautman Special Marketing Representative: David Luth

ASQ Mission: The American Society for Quality advances individual and organizational performance excellence worldwide by providing opportunities for learning, quality improvement, and knowledge exchange.

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Dedication

To Sue and our children, Chelsea and Trevor;

and

To my dedicated laboratory team, Elise, Kathy, Crystal, Tony, Mike, and Bob. “Life can be a Dreamcatcher. Keep reaching for those good dreams.”

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Table of Contents

Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Acknowledgements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Part I Quality in the Laboratory . . . . . . . . . . . . . . . . Chapter 1. . . . . . . . . . . .Quality Assurance in the Laboratory Chapter 2History of Regulation and the Laboratory . . . . . . . . . Chapter 3An Overview of Key Parameters for Evaluating a Laboratory . . . . . . . . . . . . . . . . . . . . . . . . .

Part II Critical Laboratory Operations . . . . . . . . . . . . Chapter 4Training in the Laboratory . . . . . . . . . . . . . . . . . Chapter 5Laboratory Documentation and Data . . . . . . . . . . . . Chapter 6. . . . . . . . . . . . .Sample Control and LIM Systems Appendix AEPA Good Automated Laboratory Practices . . . . . . . . Chapter 7. . . . . . . . . . . .Laboratory Equipment Qualification Chapter 8. . . . . . . . . .Equipment Calibration and Maintenance Chapter 9Laboratory Water and Water Purification Systems . . . . . Chapter 10. . . . . . . . . . . . . . . . . . . . .Methods Validation Appendix B. .ICH Guidelines on Validation of Analytical Procedures Chapter 11. . . . . . . . . . . . . . . .Out-of-Specification Results Appendix CFDA Guide for Investigating Out-of-Specification Test Results . . . . . . . . . . . . . . . . . . . . . . . . .

vii

ix xi

1 3 5

9

13 15 27 39 53 185 205 217 225 249 267

285

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Table of Contents

Part III Inspections . . . . . . . . . . . . . . . . . . . . . . . Chapter 12An FDA Approach to Laboratory Inspections . . . . . . . Appendix DFDA Guide to Inspections of Pharmaceutical Quality Control Laboratories . . . . . . . . . . . . . . . . Appendix EFDA Guide to Inspections of Microbiological Quality Control Laboratories . . . . . . . . . . . . . . . .

Part IV An International Perspective . . . . . . . . . . . . . Chapter 13. . . . . . . . . . . . . .Accreditation and Harmonization

Part V Additional Appendices . . . . . . . . . . . . . . . . . Appendix FThe OECD Principles of Good Laboratory Practice . . . . Appendix GFDA Good Laboratory Practices for Nonclinical Lab Studies . . . . . . . . . . . . . . . . . . . . . . . . .

Index

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

299 301

315

329

337 339

355 357

377

395

Preface

have been asked often, by a fellow scientist or by a student, which is the correct way to accomplish science in our laboratories and be compliant with regulations, such as an I swer is that there is no one correct way, but there is a best approach to accomplish- the current good manufacturing practices (cGMP). I have learned over time that the ing science and compliance. That approach is by following the science, in a laboratory setting, with as much scrutiny as possible, and then making sound, scientific-based decisions from the information generated. Many decisions will be judgments made with low to high risk. And the risk levels may differ from the perspective of the manager, the lab, and the company. It is the responsibility of a scientist or manager of scientists to make judgments based on sufficient facts or data. Not all decisions will be clear-cut. Some may be pretty close to a knowledgeable guess. But, there should always be some amount of practicality and sound scientific knowledge. With practicality and science as a basis for decisions, compliance should easily fall into place. A Food and Drug Admin- istration inspector follows their agency guidelines, uses their own scientific education, and publishes standards to perform an audit of a laboratory. As we presently continue to see an increase in the reported number of noncompliant findings in laboratories, we should realize that the inspectors are just looking closer than ever before. And we should be prepared for that. We have access to the same guidelines and standards as inspectors do. We have many more scientists who have thorough education and training in the actual science of the laboratory work being performed. We have written all of the procedures and validated the instrumentation used in our laboratories. Should we be able to be compliant all the time? Yes, as long as we do what we say we do, and prac- tice the way sound science is practiced. And that is the reason for this book. I have gath- ered together experts from across the laboratory science and quality assurance fields to share their knowledge. Each author provides their perspective on accomplishing good science or compliance in their area of expertise. They offer what are the best practices to meet compliance needs.

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