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 - stock.adobe.com; Cover design, Maria Xelo
Quality and Regulatory
Sourcebook March 2022
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
Manufacturing Editor Jennifer Markarian JMarkarian@mjhlifesciences.com
Science Editor Feliza Mirasol FMirasol@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
Contributing Editors Jill Wechsler jillwechsler7@gmail.com;
Hallie Forcinio editorhal@cs.com; Susan J. Schniepp sue.schniepp@mac.com;
and Cynthia A. Challener, PhD challener@vtlink.net
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
Senior Vice President, Industry Sciences Michael Tessalone
Permissions PTpress@mmhgroup.com with "Permissions" in Subject Line
Audience Development
Stacy Argondizzo SArgondizzo@mjhlifesciences.com
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 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 Mike Tracey, mtracey@mjhlifesciences.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.
19 6 0 - 2 0 2 1