BioPharm International - March 2022

BioPharm International March 2022

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2 BioPharm International eBook Quality and Regulatory Sourcebook eBook March 2022 www.biopharminternational.com Cover: Blue Planet Studio - Stock.adobe.com QUALITY: ANALYTICS Assessing the Quality of CAR-T Cells Using ddPCR Mark White and Marwan Alsarraj 4 QUALITY: VALIDATION Contextualizing Computer Validation Grant Playter 8 QUALITY: CLEANROOMS In-Use Testing of Cleanroom Garments Feliza Mirasol 10 REGULATIONS: INSPECTIONS Remote Inspections—Lessons Learned James Stumpff and Siegfried Schmitt 12 REGULATIONS: DATA INTEGRITY How a Lack of Critical Thinking is Hindering Regulatory Compliance Calvin Kim 15 The Data Relationship Felicity Thomas 20 REGULATIONS: SUPPLY CHAIN A New Route to Pharma GDP Compliance and Standardization Courtney Soulsby and Alan Kennedy 24 DSCSA's Next Big Hurdle Tracy Nasarenko 30 Supply Chain Considerations for Ensuring Quality Susan Haigney 33 COMPENDIAL COMPLIANCE Standards Facilitate Continuous Manufacturing Jennifer Markarian 37 Quality and Regulatory Sourcebook March 2022 Contents © 2022 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 BPpress@mmhgroup.com with "Permissions" in the subject line. Reprints: Contact Michael Tracey, mtracey@mjhlifesciences.com. MultiMedia Pharma Sciences LLC provides certain customer contact data (such as customers' names, addresses, phone numbers, 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. 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, email mmhinfo@mmhgroup.com FOUNDER Mike Hennessy, Sr. 1960 - 2021 ADVERTISING Publisher Mike Tracey MTracey@mjhlifesciences.com National Sales Manager Scott Vail SVail@mjhlifesciences.com European Sales Manager Linda Hewitt LHewitt@mjhlifesciences.com European Senior Sales Executive Stephen Cleland SCleland@mjhlifesciences.com Senior Vice President, Industry Sciences Michael Tessalone MTessalone@mjhlifesciences.com C.A.S.T. Data and List Information Michael Kushner MKushner@mjhlifesciences.com AUDIENCE DEVELOPMENT Audience Development Stacy Argondizzo SArgondizzo@mjhlifesciences.com MJH LIFE SCIENCES TM President & CEO Mike Hennessy Jr Chief Financial Officer Neil Glasser, CPA/CFE Chief Operating Officer Michael Ball Chief Marketing Officer Brett Melillo Executive Vice President, Global Medical Affairs & Corporate Development Joe Petroziello Senior Vice President, Content Silas Inman Vice President, Human Resources and Administration Shari Lundenberg Vice President, Mergers & Acquisitions Chris Hennessy Executive Creative Director Jeff Brown EDITORIAL Editorial Director Chris Spivey CSpivey@mjhlifesciences.com Senior Editor Felicity Thomas FThomas@mjhlifesciences.com Senior Editor Meg Rivers MRivers@mjhlifesciences.com Managing Editor Susan Haigney SHaigney@mjhlifesciences.com Science Editor Feliza Mirasol FMirasol@mjhlifesciences.com Manufacturing Editor Jennifer Markarian JMarkarian@mjhlifesciences.com Assistant Editor Grant Playter GPlayter@mjhlifesciences.com Assistant Editor Alivia Leon ALeon@mjhlifesciences.com Creative Director, Publishing Melissa Feinen Senior Art Director Marie Maresco Senior Graphic Designer Maria Xelo BioPharm I N T E R N AT I O N A L eBook 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

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