TAILIEUCHUNG - Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics

The art of compliance is a craft much like that of a carpenter who learns to work with various kinds of wood and designs. Ours is an industry wrought with differences. While the regulations that govern FDA-regulated industries are proscribed, how the regulations are interpreted and applied really depends on experience and how well one has mastered the craft of compliance. There are no proscribed procedures, but there are guideposts common to all FDA-regulated industries, whether a firm manufactures medical devices, pharmaceuticals, or biological products | Compliance Handbook for Pharmaceuticals Medical Devices and Biologies edited by Carmen Medina Precision Consultants Coronado California . MARCEL Marcel Dekker Inc. New York Basel Copyright 2004 Marcel Dekker In . . Although great care has been taken to provide accurate and current information neither the author s nor the publisher nor anyone else associated with this publication shall be liable for any loss damage or liability directly or indirectly caused or alleged to be caused by this book. The material contained herein is not intended to provide specific advice or recommendations for any specific situation. Trademark notice Product or corporate names may be trademarks or registered trademarks and are used only for identification and explanation without intent to infringe. Library of Congress Cataloging-in-Publication Data A catalog record for this book is available from the Library of Congress. ISBN 0-8247-4078-5 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 Distribution and Customer Service Marcel Dekker Inc. Cimarron Road Monticello New York 12701 . tel 800-228-1160 fax 845-796-1772 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 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 2004 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 987654321 PRINTED IN THE UNITED STATES OF .

• Sinh học
• Regulatory Submissions
• Compliance Requirements During
• Validation
• Pharmaceutical
• Stability Testing Program
• Compliance Issues Associated
• Drug Development Process
• Mass Spectrometry
• Process Chemistry
• Drug Substances
• Molecular Formula
• LC Method Development
• Atomic Physics
• discovery process
• The pharmaceutical
• the search
• plant screening
• biodiversity conservation
• drug development