2 BioPharm International eBook Quality and Regulatory Sourcebook March eBook 2023 www.biopharminternational.com
BioPharm
I N T E R N AT I O N A L
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Contents
Cover: Murrstock - Stock.adobe.com
ANALYTICS
Phase-appropriate
Analytical Methodology
Paul Van Tilborg
A phase-appropriate analytical development strategy is
crucial, especially for complex (formulated) drug substances. 4
PHARMACOVIGILANCE
Pharmacovigilance Automation
Updesh Dosanjh
Organizations can better understand the maturity of AI-driven
automation technology across their organization's IT landscape
through effective pharmacovigilance. 7
QUALITY CONTROL
Mitigating Human Error and Supporting
Compliance with Smart Technology
Mike Wilson
Technological advances hold promise for mitigating human
error in the pharmaceutical industry, especially in quality
assurance/quality control, by reducing the incidence of,
and risk associated with, mistakes. 10
VALIDATION
Evolution of Analytical Procedure
Validation Concepts: Part I
Amanda Guiraldelli and Jane Weitzel
This article provides an overview of validation concept
principles evolution to a life cycle risk-based approach with
focus on compendial perspectives. 14
Evolution of Analytical Procedure
Validation Concepts: Part II
Amanda Guiraldelli and Jane Weitzel
This article focuses on drawing parallels between
ICH Q14/Q2(R2), USP <1220>, and ISO/IEC 17025:2017. 22
KNOWLEDGE MANAGEMENT
Points to Consider for
Knowledge Management Acceleration
Cliff Campbell
Quality quartets support an integrated and stable combination
of commissioning and qualification and quality risk
management processes. 30
AD INDEX 36
Quality and Regulatory
Sourcebook March 2023
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Mike Hennessy Sr
1960 - 2021
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MJH LIFE SCIENCES
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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@mjhlifesciencs.com
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CONTRIBUTING EDITORS:
Jill Wechsler jillwechsler7@gmail.com; Hallie Forcinio, editorhal@cs.com;
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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
