© 2020 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 Permission
Dept. or email: ARockenstein@mmhgroup.com
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@mmhgroup.com. Display, Web, Classified, and Recruitment Advertising: Contact, tel.
732.346.3027. Permissions: Contact Alexa Rockenstein, tel. 732.346.3007, ARockenstein@mmhgroup.com.
To subscribe: mmhinfo@mmhgroup.com
EDITORIAL
Editorial Director Rita Peters RPeters@mjhlifesciences.com
Senior Editor Agnes Shanley AShanley@mjhlifesciences.com
Managing Editor Susan Haigney SHaigney@mjhlifesciences.com
European Editor Felicity Thomas FThomas@mjhlifesciences.com
Manufacturing Editor Jennifer Markarian JMarkarian@mjhlifesciences.com
Science Editor Feliza Mirasol FMirasol@mjhlifesciences.com
Assistant Editor Lauren Lavelle LLavelle@mjhlifesciences.com
Creative Director, Publishing Melissa Feinen
Senior Art Director Marie Maresco; Graphic Designer Maria Reyes
Contributing Editors Jill Wechsler jillwechsler7@gmail.com;
Hallie Forcinio editorhal@cs.com;
Susan J. Schniepp sue.schniepp@mac.com; Eric Langer info@bioplanassociates.com;
and Cynthia A. Challener, PhD challener@vtlink.net
Correspondent Sean Milmo (Europe, smilmo@btconnect.com)
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 Alexa Rockenstein, arockenstein@mjhlifesciences.com
Audience Development Research Director
Christine Shappell cshappell@mjhlifesciences.com
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, Operations Tom Tolvé
Executive Vice President, Global Medical Af fairs and Corporate Development
Joe Petroziello
Senior Vice President, Content Silas Inman
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
Regulatory Sourcebook October 2020
PROCESS DEVELOPMENT
4 Enhancing Process Validation for Sterile
Liquid and Freeze-Dried Forms: Part 1
Francesca Speroni, Ilaria Franceschini, Maurizio Valleri, Mauro Silvestri,
Matteo De Nigris, Simona Bertolini, Luca Rizzo, Alessia Garavaglia, Camillo
Bologna, Rosa Terribile, Stefano Pompilio, Enrico Modena, Stefano Selva,
Lorenza Broccardo, Cesare Armetti, and Marco Adami
16 Enhancing Process Validation for
Solid Oral Dosage Forms: Part 2
Francesca Speroni, Ilaria Franceschini, Maurizio Valleri, Mauro Silvestri,
Matteo De Nigris, Simona Bertolini, Luca Rizzo, Alessia Garavaglia, Camillo
Bologna, Rosa Terribile, Stefano Pompilio, Enrico Modena, Stefano Selva,
Lorenza Broccardo, Cesare Armetti, and Marco Adami
26 Due Diligence Assessment
of CMC Activities
William J. Lambert
DATA INTEGRITY
30 Do Pharmacopoeias Inadvertently
Facilitate Data Integrity Violations?
C. Burgess and R.D. McDowall
42 Tackling Cybersecurity Challenges
in Legacy Systems
Robert Brokamp and Adi Karisik
REGULATORY GUIDANCE
46 Ending 'Magical Thinking' in Compounding
Agnes Shanley
52 Viral Vector API Characterization
of Product-Related Impurities
Peter Wunderli, Jun Lu, Jie Ding, Mercedes Ames,
Marc Wolman, Jared Finger, and Stephen Gacheru
QUALITY
60 Viewpoint: Precompetitive Collaboration
Drives Pharma Industry Innovation
Margaret M. Faul, Carl L. McMillian, Pierre Boulas,
Reginaldo A. Saraceno, Mary Devlin Capizzi, and Maureen T. Cruz
65 Strong Quality Culture:
A How-To for Busy Managers
Norm Howe
RESOURCES
69 Resources, Guidelines, and Guidance Documents
73 Regulatory and Standard Setting Organizations
76 Ad Index
Cover image: Inna - stock.adobe.com; Cover design, Maria Reyes