Pharmaceutical Technology - September 2019

Pharmaceutical Technology - Regulatory Sourcebook

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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; Cover design, Maria Reyes Regulatory Sourcebook September 2019 EDITORIAL Editorial Director Rita Peters Senior Editor Agnes Shanley Managing Editor Susan Haigney European Editor Felicity Thomas Manufacturing Editor Jennifer Markarian Science Editor Feliza Mirasol Assistant Editor Lauren Lavelle Art Director Dan Ward Contributing Editors Jill Wechsler; Hallie Forcinio; Susan J. Schniepp; Eric Langer; and Cynthia A. Challener, PhD Address 485 Route One South, Building F, Second Floor, Iselin, NJ 08830, USA Tel. 732.596.0276, Fax 732.647.1235 SALES Publisher Mike Tracey East Coast Sales Manager Joel Kern Mid West, West Coast Sales Manager BJ Ghiglione European Sales Manager Linda Hewitt European Senior Sales Executive Stephen Cleland Executive Assistant Barbara Sefchick C.A.S.T. Data and List Information Michael Kushner Sr. Production Manager Karen Lenzen International Licensing Alexa Rockenstein Audience Development Research Director Christine Shappell MJH Life Sciences TM Chairman and CEO Mike Hennessy, Sr Vice Chairman Jack Lepping President Mike Hennessy, Jr Chief Strategy Officer & President, Agency Services George Glatcz Chief Accounting Officer David Brennan Chief Financial Officer Neil Glasser, CPA/CFE Executive Vice President, Operations Tom Tolvé Senior Vice President, Content Silas Inman Senior Vice President, I.T. & Enterprise Systems John Moricone Senior Vice President, Development & Enterprise Systems JP Uva Senior Vice President, Audience Generation & Product Fulfillment Joy Puzzo Vice President, Human Resources & Administration Shari Lundenberg Vice President, Business Intelligence Chris Hennessy Vice President, Corporate Branding & B2B Marketing Amy Erdman Executive Creative Director, Creative Services Jeff Brown MJH Life Sciences TM provides certain customer contact data (such as customers' names, addresses, phone numbers, and e-mail addresses) to third parties who wish to promote relevant products, ser- vices, and other opportunities that may be of interest to you. 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