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T h e S ci e n ce & B usi n e ss o f B i o p h a r m a ce u t i c a ls eBook BioPharm I N T E R N AT I O N A L Cover: oatawa, ENFORCEMENT UPDATE Warning Letters Signal Steps to Compliance Rita Peters 3 FDA INSPECTIONS Lessons from FDA 483s and cGMP Inspection Data Ajay Babu Pazhayattil, Marzena Ingram, and Naheed Sayeed 6 QUALITY RISK MANAGEMENT Quality Risk Management Plans Create Effective Quality Systems Susan J. Schniepp 12 PHARMACOPOEIA COMPLIANCE SERIES Revision Process for Global/National Pharmacopoeias J. Mark Wiggins and Joseph A. Albanese 14 Surveillance Process for Industry: Monitoring Pharmacopoeia Revisions J. Mark Wiggins and Joseph A. Albanese 26 RESOURCES Regulatory and Standard Setting Organizations 40 Resources, Guidelines, and Guidance Documents 42 Ad Index 43 Regulatory Sourcebook December 2019 Contents EDITORIAL Editorial Director Rita Peters Senior Editor Agnes M. Shanley Managing Editor Susan Haigney European Editor Felicity Thomas Science Editor Feliza Mirasol Manufacturing Editor Jennifer Markarian Assistant Editor Lauren Lavelle ADVERTISING Publisher Mike Tracey National Sales Manager Scott Vail European Sales Manager Linda Hewitt European Senior Sales Executive Stephen Cleland VP/Managing Director, Pharm/Science Group Dave Esola C.A.S.T. Data and List Information Michael Kushner PRODUCTION Senior Art Director Marie Maresco; Graphic Designer Maria Reyes AUDIENCE DEVELOPMENT Audience Development Christine Shappell MJH LIFE SCIENCES TM Chairman and Founder Mike Hennessy, Sr Vice Chairman Jack Lepping President and CEO Mike Hennessy, Jr Chief Financial Officer Neil Glasser, CPA/CFE Executive Vice President, Operations Tom Tolvé Senior Vice President, Content Silas Inman Senior Vice President, I.T. & Enterprise Systems John Moricone Senior Vice President, Development & Enterprise Systems John Paul Uva Senior Vice President, Audience Generation & Product Fulfillment Joy Puzzo Vice President, Human Resources & Administration Shari Lundenberg Vice President, Business Intelligence Chris Hennessy Vice President, Corporate Branding & B2B Marketing Amy Erdman Executive Creative Director, Creative Services Jeff Brown © 2019 MultiMedia Pharma Sciences LLC All rights reser ved. No par t of this publication may be reproduced or transmit ted in any form or by any means, electronic or mechanical including by photocopy, recording, or information storage and retrieval without permission in writing from the publisher. Authorization to photocopy items for internal/educational or personal use, or the internal/educational or personal use of specific clients is granted by MultiMedia Pharma Sciences LLC for libraries and other users registered with the Copyright Clearance Center, 222 Rosewood Dr. Danvers, MA 01923, 978-750-8400fa x 978-646-8700 or visit ht tp:// w w online. For uses beyond those listed above, please direct your writ ten request to Permission Dept. Alexa Rockenstein, arockenstein@mmhgroup. com. Reprints: Contact Michael Tracey, MultiMedia Pharma Sciences LLC provides cer tain customer contact data (such as customers' names, addresses, phone numbers, and e-mail addresses) to t hir d p ar t i e s w ho w i sh to pr omo t e r e l e v a n t pr o du c t s , s er v i c e s , a n d o t h er opportunities that may be of interest to you. If you do not want MultiMedia Pharma S ci enc e s L LC to ma ke your c on t ac t in for ma t ion av ail abl e to t hir d p ar t i e s for mar ke ting purposes, simpl y c all toll-free 8 6 6 -529 -29 2 2 be t ween the hour s of 7:30 a.m. and 5 p.m. CST and a customer service representative will assist you in removing your name from MultiMedia Pharma Sciences LLC lists. Outside the U.S., please phone 218-740-6477. BioPharm International d o e s n o t v er i f y a n y c l a im s or o t h er in f or m a t i o n appearing in any of the adver tisements contained in the publication, and cannot take responsibility for any losses or other damages incurred by readers in reliance of such content. BioPharm International welcomes unsolicited articles, manuscripts, photographs, illustrations, and other materials but cannot be held responsible for their safekeeping or return. To subscribe, call toll-free 888-527-7008. Outside the U.S. call 218-740-6477

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