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No other area of regulatory compliance receives more attention and scrutiny by regulatory authorities than the regulation of sterile products, for obvious reasons. With the increasing number of potent products, particularly the new line of small protein products, joining the long list of proven sterile products, the technology of manufacturing sterile products has evolved into a very sophisticated industry. Highlights from Sterile Products, Volume Six include: formulations of sterile dosage forms, regulatory filing requirements of sterile preparations, and cGMP compliance, all of which are tied together in the final preparation of the CMC sections of regulatory applications specifications of a manufacturing facility to manufacture compliant sterile products NDA or aNDA filing requirements of sterile products an alphabetical presentation of formulations of pharmaceutical products based on their generic names
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V O L U M E
S I X
Second Edition
Handbook of
Pharmaceutical Manufacturing Formulations Sterile Products
S a r f a r a z K. N i a z i Pharmaceutical Scientist, Inc. Deerfield, Illinois, USA
Handbook of Pharmaceutical Manufacturing Formulations Second Edition Volume Series Sarfaraz K. Niazi Volume 1 Handbook of Pharmaceutical Manufacturing Formulations: Compressed Solid Products Volume 2 Handbook of Pharmaceutical Manufacturing Formulations: Uncompressed Solid Products Volume 3 Handbook of Pharmaceutical Manufacturing Formulations: Liquid Products Volume 4 Handbook of Pharmaceutical Manufacturing Formulations: Semisolid Products Volume 5 Handbook of Pharmaceutical Manufacturing Formulations: Over-the-Counter Products Volume 6 Handbook of Pharmaceutical Manufacturing Formulations: Sterile Products
Informa Healthcare USA, Inc. 52 Vanderbilt Avenue New York, NY 10017 C
2009 by Informa Healthcare USA, Inc. Informa Healthcare is an Informa business No claim to original U.S. Government works Printed in the United States of America on acid-free paper 10 9 8 7 6 5 4 3 2 1 International Standard Book Number-10: 1-4200-8116-0 (Volume 1; Hardcover) International Standard Book Number-13: 978-1-4200-8116-9 (Volume 1: Hardcover) International Standard Book Number-10: 1-4200-8118-7 (Volume 2; Hardcover) International Standard Book Number-13: 978-1-4200-8118-3 (Volume 2; Hardcover) International Standard Book Number-10: 1-4200-8123-3 (Volume 3; Hardcover) International Standard Book Number-13: 978-1-4200-8123-7 (Volume 3; Hardcover) International Standard Book Number-10: 1-4200-8126-8 (Volume 4; Hardcover) International Standard Book Number-13: 978-1-4200-8126-8 (Volume 4; Hardcover) International Standard Book Number-10: 1-4200-8128-4 (Volume 5; Hardcover) International Standard Book Number-13: 978-1-4200-8128-2 (Volume 5; Hardcover) International Standard Book Number-10: 1-4200-8130-6 (Volume 6; Hardcover) International Standard Book Number-13: 978-1-4200-8130-5 (Volume 6; Hardcover) This book contains information obtained from authentic and highly regarded sources. Reprinted material is quoted with permission, and sources are indicated. A wide variety of 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 hereafter invented, 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 Cl