Pharmaceutical Technology - March 2021

Pharmaceutical Technology - Regulatory Sourcebook - March 2021

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EDITORIAL Editorial Director Rita Peters Senior Editor Agnes Shanley Managing Editor Susan Haigney European Editor Felicity Thomas Manufacturing Editor Jennifer Markarian Science Editor Feliza Mirasol Assistant Editor Lauren Lavelle Creative Director, Publishing Melissa Feinen Senior Art Director Marie Maresco; Senior Graphic Designer Maria Reyes Contributing Editors Jill Wechsler; Hallie Forcinio; Susan J. Schniepp; Eric Langer; and Cynthia A. Challener, PhD 485 Route One South, Building F, Second Floor, Iselin, NJ 08830, USA Tel. 732.596.0276, Fax 732.647.1235, Address 485 Route One South, Building F, Second Floor, Iselin, NJ 08830, USA Tel. 732.596.0276, Fax 732.647.1235 SALES Publisher Mike Tracey East Coast Sales Manager Joel Kern Mid West, West Coast Sales Manager BJ Ghiglione European Sales Manager Linda Hewitt European Senior Sales Executive Stephen Cleland C.A.S.T. Data and List Information Michael Kushner Senior Vice President, Industry Sciences Michael Tessalone Permissions Alexa Rockenstein, Audience Development Research Director Christine Shappell 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 Chief Marketing Of ficer Michael Baer Executive Vice President, Global Medical Af fairs and Corporate Development Joe Petroziello Senior Vice President, Content Silas Inman Senior Vice President, Operations Michael Ball Senior Vice President, I.T. & Enterprise Systems John Moricone Vice President, Human Resources & Administration Shari Lundenberg Vice President, Mergers & Acquisitions Chris Hennessy Executive Creative Director, Creative Services Jeff Brown © 2021 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 online. For uses beyond those listed above, please direct your written request to Permission Dept. or email: 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 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, Display, Web, Classified, and Recruitment Advertising: Contact, tel. 732.346.3027. To subscribe: Regulatory Sourcebook March 2021 QUALITY 4 Can FDA Reinvent On-Site Inspections? Agnes Shanley 6 FDA 2021 Guidance Agenda Sees Focus on Generics Susan Haigney OPERATIONS 10 A Real-World Approach to Evaluating Cleanroom Garments Anne Marie Dixon-Heathman QUALITY COLLABORATION 22 Special Section: It Takes a Bio/Pharma Village The editors of Pharmaceutical Technology 24 Enabling the Virtual Human Through Physiologically-based Pharmacokinetic Modeling Heidi J. Einolf, Stephen D. Hall, Tracy Williams, Aarti Patel, Christopher Gibson, Nancy G.B. Agrawal, and Jens Sydor 28 Managing the Risk of Nitrosamine Impurities Timothy Curran and J.P. Bercu 36 Overcoming Challenges to Biopharmaceutical Development and Manufacture with Science- and Risk-Based Strategies Saroj Ramdas, Renata Varga, Martin Gastens, Twinkle R. Christian, Bharat Jagannathan, Barbara Rellahan, and Jillian Brady 42 Extrapolating Data from Adult Clinical Trials to Advance Pediatric Drug Development Sebastian Haertter, S.Y. Amy Cheung, Angela James, Ashley Strougo, Christina Bucci-Rechtweg, Jing Liu, Meina Tao Tang, Paulien Ravenstijn, Raafat Bishai, Satyendra Suryawanshi, and Solange Corriol-Rohou 48 Collaborative Efforts Address Key Data Integrity Challenges Ganapathy Mohan, Christopher Turner, Dennis O'Connor, Lisa Fink, Thomas Purdue, Jeffrey Beebie, Kerri Robles, and Karen Waetjen RESOURCES 52 Resources, Guidelines, and Guidance Documents 58 Regulatory and Standard Setting Organizations 61 Ad Index Cover image: GoodIdeas -; Cover design, Maria Reyes

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