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REGULATORY UPDATE
4 A "New Normal" for Quality?
Rita Peters
GENE AND CELL THERAPIES
6 Inside FDA's New Gene and
Cell Therapy Guidances
Agnes Shanley
DATA INTEGRITY
10 ALCOA+ and Data Integrity
Susan J. Schniepp
PHARMACOPOEIA COMPLIANCE SERIES
14 Monograph Development:
Why and When to Participate
J. Mark Wiggins and Joseph A. Albanese
24 A Practical Approach to
Pharmacopoeia Compliance
J. Mark Wiggins and Joseph A. Albanese
34 Pharmacopoeia Compliance:
Putting It All Together; What Is on the Horizon
J. Mark Wiggins and Joseph A. Albanese
RESOURCES
44 Regulatory and
Standard Setting Organizations
48 Resources, Guidelines,
and Guidance Documents
On the Cover: Sikov - Stock.adobe.com
Regulatory Sourcebook March 2020
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
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
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MJH LIFE SCIENCES
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Almac Group ............................................................................3
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