Validación De Equipos De Laboratorio

Validation and Qualification in Analytical Laboratories

Validation and Qualification in Analytical Laboratories
Second Edition

Ludwig Huber
Agilent Technologies Waldbronn, Germany

Informa Healthcare USA, Inc. 52 Vanderbilt Avenue New York, NY 10017 c 2007 by Informa Healthcare USA, Inc. Informa Healthcare is an Informa business No claim to original U.S. Government works Printed inthe United States of America on acid-free paper 10 9 8 7 6 5 4 3 2 1 International Standard Book Number-10: 0-8493-8267-X (hardcover : alk. paper) International Standard Book Number-13: 978-0-8493-8267-3 (hardcover : alk. paper) This book contains information obtained from authentic and highly regarded sources. Reprinted material is quoted with permission, and sources are indicated. A wide varietyof references are listed. Reasonable efforts have been made to publish reliable data and information, but the author and the publisher cannot assume responsibility for the validity of all materials or for the consequence of their use. No part of this book may be reprinted, reproduced, transmitted, or utilized in any form by any electronic, mechanical, or other means, now known or hereafterinvented, including photocopying, microfilming, and recording, or in any information storage or retrieval system, without written permission from the publishers For permission to photocopy or use material electronically from this work, please access www.copyright.com (http://www.copyright.com/) or contact the Copyright Clearance Center, Inc. (CCC) 222 Rosewood Drive, Danvers, MA 01923, 978-750-8400. CCCis a not-for-profit organization that provides licenses and registration for a variety of users. For organizations that have been granted a photocopy license by the CCC, a separate system of payment has been arranged. Trademark Notice: Product or corporate names may be trademarks or registered trademarks, and are used only for identification and explanation without intent to infringe. Visit theInforma Web site at www.informa.com and the Informa Healthcare Web site at www.informahealthcare.com

Library of Congress Cataloging-in-Publication Data Huber, Ludwig, 1948Validation and qualification in analytical laboratories / Ludwig Huber. – 2nd ed. p. ; cm. Includes bibliographical references and index. ISBN-13: 978-0-8493-8267-3 (hardcover : alk. paper) ISBN-10: 0-8493-8267-X (hardcover : alk.paper) 1. Chemistry, Analytic–Quality control. 2. Chemical laboratories–Standards. I. Title. [DNLM: 1. Chemistry, Pharmaceutical–standards. 2. Chemistry, Analytical–standards. 3. Drug Industry–standards. 4. Laboratories–standards. 5. Quality Control. QV 744 H877v 2007] QD75.4.Q34H83 2007 543.068’5–dc22 2007020360

Preface

Validation and qualification of analytical methods and equipment arerequired by many regulations, regulatory guidance documents, quality standards, and company policies. If executed correctly, they also help to improve the reliability, consistency, and accuracy of analytical data. This book, Validation and Qualification in Analytical Laboratories, guides analysts, laboratory managers, quality assurance managers, and validation professionals through the validation andqualification processes in analytical laboratories. The validation and qualification procedures presented in this book help to ensure compliance and quality, but with minimal extra cost and administrative complexity. Its purpose is to answer the key question regarding validation: How much validation is needed and how much is sufficient? The recommendations are complementary rather than contradictoryto any regulations, standards, or official guidelines. They are based mainly on common sense and can be used in cases where information from official guidelines and standards is insufficient for day-to-day work. This book addresses both international and national regulations and quality standards. Its concept, examples, templates, and operating procedures are based on my more than twenty years of...