Pharmaceutical Technology - March 2020

Pharmaceutical Technology - Regulatory Sourcebook

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P h a r mTe c h . c o m © 2020 MultiMedia Pharma Sciences LLC All rights reserved. No part of this publication may be reproduced or transmitted 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, 978-750-8400 fax 978-646-8700 or visit http://www.copyright.com online. For uses beyond those listed above, please direct your written request to Permission Dept. or email: ARockenstein@mjhlifesciences.com MultiMedia Pharma Sciences LLC provides certain customer contact data (such as customers name, addresses, phone num- bers, and e-mail addresses) to third parties who wish to promote relevant products, services, and other opportunities that may be of interest to you. If you do not want MultiMedia Pharma Sciences LLC to make your contact information available to third parties for marketing purposes, simply email mmhinfo@mmhgroup.com and a customer service representative will assist you in removing your name from MultiMedia Pharma Sciences LLC lists. Pharmaceutical Technology 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. Pharmaceutical Technology welcomes unsolicited articles, manuscripts, photographs, illustrations, and other materials but cannot be held responsible for their safekeeping or return. Reprints: Contact Mike Tracey, mtracey@mjhlifesciences.com. Display, Web, Classified, and Recruitment Advertising: Contact, tel. 732.346.3027. Permissions: Contact Alexa Rockenstein, tel. 732.346.3007, ARockenstein@mjhlifesciences.com. To subscribe: mmhinfo@mmhgroup.com REGULATORY UPDATE 4 A "New Normal" for Quality? Rita Peters GENE AND CELL THERAPIES 6 Inside FDA's New Gene and Cell Therapy Guidances Agnes Shanley DATA INTEGRITY 10 ALCOA+ and Data Integrity Susan J. Schniepp PHARMACOPOEIA COMPLIANCE SERIES 14 Monograph Development: Why and When to Participate J. Mark Wiggins and Joseph A. Albanese 24 A Practical Approach to Pharmacopoeia Compliance J. Mark Wiggins and Joseph A. Albanese 34 Pharmacopoeia Compliance: Putting It All Together; What Is on the Horizon J. Mark Wiggins and Joseph A. Albanese RESOURCES 44 Regulatory and Standard Setting Organizations 48 Resources, Guidelines, and Guidance Documents On the Cover: Sikov - Stock.adobe.com Regulatory Sourcebook March 2020 EDITORIAL Editorial Director Rita Peters RPeters@mjhlifesciences.com Senior Editor Agnes Shanley AShanley@mjhlifesciences.com Managing Editor Susan Haigney SHaigney@mjhlifesciences.com European Editor Felicity Thomas FThomas@mjhlifesciences.com Manufacturing Editor Jennifer Markarian JMarkarian@mjhlifesciences.com Science Editor Feliza Mirasol FMirasol@mjhlifesciences.com Assistant Editor Lauren Lavelle LLavelle@mjhlifesciences.com Senior Art Director Marie Maresco; Graphic Designer Maria Reyes Contributing Editors Jill Wechsler jillwechsler7@gmail.com; Hallie Forcinio editorhal@cs.com; Susan J. Schniepp sue.schniepp@mac.com; Eric Langer info@bioplanassociates.com; and Cynthia A. Challener, PhD challener@vtlink.net Correspondent Sean Milmo (Europe, smilmo@btconnect.com) 485 Route One South, Building F, Second Floor, Iselin, NJ 08830, USA Tel. 732.596.0276, Fax 732.647.1235, PharmTech.com Address 485 Route One South, Building F, Second Floor, Iselin, NJ 08830, USA Tel. 732.596.0276, Fax 732.647.1235 PharmTech.com SALES Publisher Mike Tracey MTracey@mjhlifesciences.com East Coast Sales Manager Joel Kern JKern@mjhlifesciences.com Mid West, West Coast Sales Manager BJ Ghiglione BGhiglione@mjhlifesciences.com European Sales Manager Linda Hewitt LHewitt@mjhlifesciences.com European Senior Sales Executive Stephen Cleland SCleland@mjhlifesciences.com C.A.S.T. Data and List Information Michael Kushner MKushner@mjhlifesciences.com VP/Managing Director, Pharm/Science Group Dave Esola International Licensing Alexa Rockenstein ARockenstein@mjhlifesciences.com Audience Development Research Director Christine Shappell cshappell@mjhlifesciences.com MJH LIFE SCIENCES TM Chairman and Founder Mike Hennessy, Sr Vice Chairman Jack Lepping President and CEO Mike Hennessy, Jr Chief Financial Of ficer 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, 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 Almac Group ............................................................................3 DWK Life Sciences .................................................................25 Nelson Laboratories, LLC .................................................... 33 Pfanstiehl ............................................................................... 43 PPD Laboratories ..................................................................49 Veltek .......................................................................................11 Ad Index COMPANY PAGE

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