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2 Pharmaceutical Technology ® Quality and Regulatory Sourcebook eBook March 2024 PharmTech.com MANUFACTURING 4 Review of SUT Adoption in Biopharma Manufacturing Ramesh Raju Mavuleti, K. Vasantakumar Pai, K. Sreedhara Ranganath Pai, Subhasis Banerjee, Somasundaram Gopalakrishnan, and Tathagata Ray ASEPTIC MANUFACTURING 10 Filtration Clarification Needs in Annex 1 Maik W. Jornitz 14 Intervention Risk Evaluation and Management in Aseptic Manufacturing–Part II Subrata Chakraborty, Hal Baseman, and Michael A. Long QUALITY BY DESIGN 26 Digitalization of QbD Risk Assessments Gayathri Acharya, Matthew Pincus, Hervé Gressard, and Phil Borman REGULATORY SUBMISSIONS 35 The Importance of Quality Data for Regulatory Submissions Claude Price Cover image: Rosenei - stock. adobe.com; Cover design: Chrissy Bolton Quality and Regulatory Sourcebook March 2024 © 2024 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 PTpress@mmhgroup.com 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 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 Brian Haug, bhaug@mmhgroup.com. Display, Web, Classified, and Recruitment Advertising: Contact, tel. 732.346.3027. To subscribe: mmhinfo@mmhgroup.com F O U N D E R Mike Hennessy Sr 1 9 6 0 - 2 0 2 1 EDITORIAL Vice President, Content Alicia Bigica ABigica@mjhlifesciences.com Editorial Director Chris Spivey CSpivey@mjhlifesciences.com Senior Editor Felicity Thomas FThomas@mjhlifesciences.com Lead Editor Susan Haigney SHaigney@mjhlifesciences.com Science Editor Feliza Mirasol FMirasol@mjhlifesciences.com Assistant Editor Daria Husni DHusni@mjhlifesciences.com Creative Director, Publishing Robert McGarr Senior Art Director Kristen Moribato; Senior Graphic Designer Chrissy Bolton CONTRIBUTING EDITORS Hallie Forcinio, editorhal@cs.com; Susan J. Schniepp, sue.schniepp@mac.com; Cynthia A. Challener, PhD challener@vtlink.net CUSTOM CONTENT Director Robert Alaburda; Managing Editor Jeanne Linke Northrop; Senior Editor Megan Manzano; Senior Editor Shannon Stolz SALES East Coast Sales Manager Joel Kern JKern@mjhlifesciences.com Mid West, West Coast Sales Manager BJ Ghiglione BGhiglione@mjhlifesciences.com Associate Publisher of Pharmaceutical Technology Europe Linda Hewitt LHewitt@mjhlifesciences.com European Sales Manager Stephen Cleland SCleland@mjhlifesciences.com Vice President, Pharmaceutical Sciences Todd Baker TBaker@mjhlifesciences.com Executive Vice President, Healthcare and Industry Sciences Brian Haug BHaug@mmhgroup.com ADDRESS 485 Route One South, Building F, Second Floor, Iselin, NJ 08830, USA Tel. 732.596.0276, Fax 732.647.1235 PharmTech.com MJH LIFE SCIENCES ® President & CEO Mike Hennessy Jr Chief Financial Officer Neil Glasser, CPA/CFE Chief Marketing Officer Brett Melillo Chief Data Officer Terric Townsend 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 Phil Talamo Executive Creative Director Jeff Brown