Quality Systems

Amanda Guiraldelli is Scientific Affairs Manager, United States Pharmacopeia, Rockville, MD.

Articles

This article provides an overview of validation concept principles evolution to a life cycle risk-based approach with focus on compendial perspectives. 

Evolution of Analytical Procedure Validation Concepts: Part I – Analytical Procedure Life Cycle and Compendial Approaches

Julie Lippke, analytical research and development at Pfizer Inc., Groton, CT

Joseph Mongillo, analytical research and development at Pfizer Inc., Groton, CT

Thomas Cullen, analytical research and development, AbbVie Inc., North Chicago, IL

Christian Metz works in Analytical Research and Development at AbbVie Inc., Ludwigshafen, Germany.

Katria Harasewych, quality, Merck & Co., Inc., Kenilworth, NJ

Fouad Benamira works in Analytical Development Sciences for Biologicals at UCB S.A. Belgium.

The IQ Working Group has defined a pragmatic risk-based approach to audit trail review, where it is only required for high impact GxP data.

A Harmonized Approach to Performing a Risk-Based Audit Trail Review

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Although not easy to do, it is essential because excipients can affect drug-product safety and efficacy.

Bringing Excipients into the Quality-by-Design Paradigm

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about the difference between the roles of quality assurance and quality control.

Frequently Asked Questions About Quality Control vs. Quality Assurance

Raphael Bar, PhD, rbar@netvision.net.il, is a consultant at BR Consulting in Ness Ziona, Israel.

Part 1 of this article series demonstrates, using real-world process data, that the four fundamental assumptions underlying the classical Shewhart control charts—randomness, independence, constant average, and constant variation—are often not met.

Practical SPC Rules in the Real World of an Ongoing Process Verification Plan: Part 1. Conventional SPC Rules and Pharmaceutical Process Data

Ajay Pazhayattil*, M.Pharm, DBA, Ajay.Pazhayattil@capcium.com, is vice-president, Scientific and Regulatory Affairs at Capcium.

Sanjay Sharma is vice-president and head of technology transfer at Lupin Pharmaceuticals

Amol Galande is senior manager of the process development laboratory at Lupin Pharmaceuticals

Marzena Ingram is senior manager, quality and compliance at Eurofins CDMO. She led and hosted several cGMP audits, and has diverse quality assurance and technical operations experience. 

Robert Rhoades is managing partner at Validant.

A data-driven strategy can assess the quality of legacy drugs developed before 2011 process-validation requirements were established.

Assessing Legacy Drug Quality 

Shahid Manzur is principal, Consulting, EY, shahid.manzur@ey.com

Automated systems help detect and resolve quality issues.

Best Practices for Pharma Manufacturing Quality Teams

Applying a QbD approach helps address excipient variability and other quality features.

QbD Helps Evaluate Excipient Variability 

Editor of Pharmaceutical Technology Europe

Accelerated formulation strategies are a useful tool to reduce development timelines and cost, but key priorities must be considered early on to ensure success.

Focusing on Accelerated Formulation Strategies

Phil Borman, DSc, has served in multiple quality-related roles at GlaxoSmithKline; as of April 2021, he is senior fellow and director of product quality.

Timothy Schofield is owner and consultant, CMC Sciences, LLC;

David Lansky, PhD, is president, Precision Bioassay, Inc.

A well-chosen replication strategy can effectively reduce the uncertainty for an analytical method, enabling appropriate decisions regarding pharmaceutical quality. 

Quality by Design