Pharmaceutical Technology - March 2022

Pharmaceutical Technology March 2022

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QUALITY: VALIDATION 4 A Method Validation Framework for Combination Products Adam Lambert 10 Common FDA 483 Observations for Combination Products Adam Lambert 16 Contexualizing Computer Validation Grant Playter 20 Qualifying AI Algorithms for Manufacturing Toni Manzano QUALITY: CLEANROOMS 24 In-Use Testing of Cleanroom Garments Feliza Mirasol REGULATIONS: INSPECTIONS 28 Remote Inspections—Lessons Learned James Stumpff and Siegfried Schmitt REGULATIONS: DATA INTEGRITY 34 How a Lack of Critical Thinking is Hindering Regulatory Compliance Calvin Kim REGULATIONS: SUPPLY CHAIN 40 DSCSA's Next Big Hurdle Tracy Nasarenko 46 Supply Chain Considerations for Ensuring Quality Susan Haigney STANDARDS 52 Facilitating Biopharma Continuous Manufacturing Jennifer Markarian 51 Ad Index Cover image: everythingpossible -; Cover design, Maria Xelo Quality and Regulatory Sourcebook March 2022 EDITORIAL Editorial Director Chris Spivey Senior Editor Felicity Thomas Senior Editor Meg Rivers Managing Editor Susan Haigney Manufacturing Editor Jennifer Markarian Science Editor Feliza Mirasol Assistant Editor Grant Playter Assistant Editor Alivia Leon Creative Director, Publishing Melissa Feinen Senior Art Director Marie Maresco; Senior Graphic Designer Maria Xelo Contributing Editors Jill Wechsler; Hallie Forcinio; Susan J. Schniepp; 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 with "Permissions" in Subject Line Audience Development Stacy Argondizzo MJH LIFE SCIENCES® President & CEO Mike Hennessy Jr Chief Financial Of ficer Neil Glasser, CPA/CFE Chief Operating Of ficer Michael Ball Chief Marketing Of ficer Brett Melillo Executive Vice President, Global Medical Af fairs & 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 © 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 online. For uses beyond those listed above, please direct your written request to with "Permissions Department" in the subject line. 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: F O U N D E R Mike Hennessy, Sr. 19 6 0 - 2 0 2 1

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