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Contents BioPharm I N T E R N AT I O N A L eBook Regulatory Sourcebook September 2019 COMPLIANCE REPORT CARD Quality Culture Drives Patient Confidence in Drug Products Rita Peters 4 REGULATORY GUIDANCE UPDATE What's Happening in Regulatory Guidance for Biologics The Editors of BioPharm International 7 GOOD MANUFACTURING PRACTICES Is It Time to Update cGMPs? Agnes Shanley 10 BIOSIMILARS Biosimilar Quality Requirements Feliza Mirasol 14 PHARMACOPOEIA COMPLIANCE SERIES Why Pharmacopoeia Compliance Is Necessary J. Mark Wiggins and Joseph A. Albanese 18 Why Pharmacopoeia Compliance is Difficult J. Mark Wiggins and Joseph A. Albanese 26 Global Pharmacopoeia Standards: Why Harmonization is Needed J. Mark Wiggins and Joseph A. Albanese 36 RESOURCES Regulatory and Standard Setting Organizations 42 Resources, Guidelines, and Guidance Documents 44 Ad Index 45 Cover: weerapat1003 - stock.adobe.com T h e S ci e n ce & B u si n e ss o f B i o p h a r m a ce u t i c a ls © 2019 MJH Life Sciences TM A ll rights reser ved. No par t of this public ation may be reproduced or transmit ted in any form or by any means, electronic or mechanical i n c l u d i n g b y p h o t o c o p y, r e c o r d i n g , o r i n f o r m a t i o n s t o r a g e a n d r e t r i e v a l w i t h o u t permission in writing from the publisher. Authorization to photocopy items for internal/ educ ational or per sonal use, or the in ter nal /educ ational or per sonal use of speci fic clients is granted by MJH Life Sciences TM for libraries and other users registered with the Copyright Clearance Center, 222 Rosewood Dr. Danvers, MA 01923, 978-750-8400 f a x 9 7 8 - 6 4 6 - 8 7 0 0 o r v i s i t h t t p : // w w w. c o p y r i g h t . c o m o n l i n e . F o r u s e s b e y o n d t h o s e l i s t e d a b o v e , p l e a s e d i r e c t y o u r w r i t t e n r e q u e s t t o P e r m i s s i o n D e p t . Alexa Rockenstein, arockenstein@mmhgroup.com. MJH Life Sciences TM provides certain customer contact data (such as customers' names, addresses, phone numbers, and e-mail addresses) to third par ties who wish to promote relevant products, services, and other opportunities that may be of interest to you. If you do not want MJH Life Sciences TM to make your contact information available to third parties for marketing purposes, simply call toll-free 866-529-2922 between the hours of 7:30 a.m. and 5 p.m. CST and a customer ser vice representative will assist you in removing your name from MJH Life Sciences TM ' lists. Outside the U.S., please phone 218-740-6477. BioPharm International does not verify any claims or other information appearing in any of the advertisements 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. EDITORIAL Editorial Director Rita Peters RPeters@mmhgroup.com Senior Editor Agnes M. Shanley AShanley@mmhgroup.com Managing Editor Susan Haigney SHaigney@mmhgroup.com European Editor Felicity Thomas FThomas@mmhgroup.com Science Editor Feliza Mirasol FMirasol@mmhgroup.com Manufacturing Editor Jennifer Markarian JMarkarian@mmhgroup.com Assistant Editor Lauren Lavelle LLavelle@mmhgroup.com ADVERTISING Publisher Mike Tracey MTracey@mmhgroup.com National Sales Manager Scott Vail SVail@mmhgroup.com European Sales Manager Linda Hewitt LHewitt@mmhgroup.com European Senior Sales Executive Stephen Cleland SCleland@mmhgroup.com VP/Managing Director, Pharm/Science Group Dave Esola DEsola@mmhgroup.com C.A.S.T. Data and List Information Michael Kushner MKushner@mmhgroup.com PRODUCTION Production Manager Jesse Singer jsinger@hcl.com AUDIENCE DEVELOPMENT Audience Development Christine Shappell cshappell@mmhgroup.com MJH LIFE SCIENCES TM Chairman and CEO Mike Hennessy, Sr Vice Chairman Jack Lepping President Mike Hennessy, Jr Chief Strategy Officer & President, Agency Services George Glatcz Chief Accounting Officer David Brennan 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 JP 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 www.biopharminternational.com September 2019 BioPharm International eBook 3