P h a r mTe c h . c o m
COMPLIANCE REPORT CARD
4 Quality Culture Drives Patient
Confidence in Drug Products
Rita Peters
GUIDANCE UPDATE
6 What's New in
Regulations and Compliance
The Editors of Pharmaceutical Technology
ANALYTICAL PROCEDURE VALIDATION
12 Risk-Based Intermediate Precision
Studies for Analytical Procedure Validation
Phil Borman, Marion Chatfield, Hatsuki Asahara,
Fumiko Tamura, and Adam Watkins
GENERIC PHARMACEUTICALS
24 Generics: Getting Beyond
"File First, Figure It Out Later"
Agnes Shanley
PHARMACOPOEIA COMPLIANCE SERIES
28 Why Pharmacopoeia
Compliance Is Necessary
J. Mark Wiggins and Joseph A. Albanese
36 Why Pharmacopoeia
Compliance Is Difficult
J. Mark Wiggins and Joseph A. Albanese
43 Global Pharmacopoeia Standards:
Why Harmonization is Needed
J. Mark Wiggins and Joseph A. Albanese
RESOURCES
48 Regulatory and Standard
Setting Organizations
52 Resources, Guidelines,
and Guidance Documents
54 Ad Index
Cover image: wladimir1804 stock.adobe.com; Cover design, Maria Reyes
Regulatory Sourcebook September 2019
EDITORIAL
Editorial Director Rita Peters RPeters@mmhgroup.com
Senior Editor Agnes Shanley AShanley@mmhgroup.com
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European Editor Felicity Thomas FThomas@mmhgroup.com
Manufacturing Editor Jennifer Markarian JMarkarian@mmhgroup.com
Science Editor Feliza Mirasol FMirasol@mmhgroup.com
Assistant Editor Lauren Lavelle LLavelle@mmhgroup.com
Art Director Dan Ward
Contributing Editors Jill Wechsler jillwechsler7@gmail.com;
Hallie Forcinio editorhal@cs.com;
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and Cynthia A. Challener, PhD challener@vtlink.net
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