Pharmaceutical Technology - March 2023

Pharmaceutical Technology- March 2023

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2 Pharmaceutical Technology ® Quality and Regulatory Sourcebook March 2023 PharmTech.com ANALYTICS 4 Phase-appropriate Analytical Methodology Paul Van Tilborg PHARMACOVIGILANCE 8 Pharmacovigilance Automation Updesh Dosanjh 12 Overcoming Data Gaps in Pharmacovigilance Pankaj Bhardwaj and Ryanka Chauhan QUALITY CONTROL 18 Mitigating Human Error and Supporting Compliance with Smart Technology Mike Wilson MANUFACTURING 24 Quality Considerations for the Manufacture of Compounded Drugs Susan Haigney KNOWLEDGE MANAGEMENT 30 Points to Consider for Knowledge Management Acceleration Cliff Campbell VIEWPOINT 38 How Banning TiO 2 Might Impact Pharma David R. Schoneker 41 Ad Index Cover image: putilov_denis - stock.adobe.com; Cover design, Maria Xelo Quality and Regulatory Sourcebook March 2023 © 2023 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. 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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 1 9 6 0 - 2 0 2 1 EDITORIAL Editorial Director Chris Spivey CSpivey@mjhlifesciences.com Senior Editor Felicity Thomas FThomas@mjhlifesciences.com Managing Editor Susan Haigney SHaigney@mjhlifesciences.com Science Editor Feliza Mirasol FMirasol@mjhlifesciences.com Editor Jill Murphy JMurphy@mjhlifesciences.com Associate 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; Cynthia A. Challener, PhD challener@vtlink.net ; and Jennifer Markarian, Manufacturing Reporter. CUSTOM CONTENT: Vice President, Content and Special Projects Colleen Hall; Director Robert Alaburda; Managing Editor Jeanne Linke Northrop; Senior Editor Megan Manzano; Senior Editor Shannon Stolz; Senior Writer Zainab Kahn SALES Executive Vice President, Healthcare Brian Haug BHaug@mmhgroup.com Vice President, Pharmaceutical Sciences Todd Baker TBaker@mjhlifesciences.com 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 Associate Publisher of Pharmaceutical Technology Europe Linda Hewitt LHewitt@mjhlifesciences.com European Sales Manager Stephen Cleland SCleland@mjhlifesciences.com Audience Development Stacy Argondizzo SArgondizzo@mjhlifesciences.com ADDRESS 485 Route One South, Building F, Second Floor, Iselin, NJ 08830, USA Tel. 732.596.0276, Fax 732.647.1235 PharmTech.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 Chief Data Of ficer Terric Townsend 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 Phil Talamo Executive Creative Director Jeff Brown

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