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Stevens Institute of Technology, Hoboken, NJ. Details strategies to establish appropriate validation protocols and conduct process validation assignments, monitor and test specific manufacturing processes for compliance with design limits, and more.
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Copyright © 2003 Marcel Dekker, Inc.
Previous edition: Pharmaceutical Process Validation: Second Edition, Revised and Expanded (I. R. Berry, R. A. Nash, eds.), 1993.
Library of Congress Cataloging-in-Publication Data A catalog record for this book is available from the Library of Congress. ISBN: 0-8247-0838-5 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 quantities. 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 2
Copyright © 2003 Marcel Dekker, Inc.
DRUGS AND THE PHARMACEUTICAL SCIENCES
Executive Editor
James Swarbrick PharmaceuTech, Inc Pinehurst, North Carolina
Advisory Board Larry L. Augsburger University of Maryland Baltimore, Maryland Douwe D. Breimer Gorlaeus Laboratories Leiden, The Netherlands
David E. Nichols Purdue Uni