Jason Brown*, Adare Pharma Solutions and Kim Huynh-Ba, Pharmalytik, LLC
*Corresponding Author
Abstract
Nitrosamine impurities have emerged as a significant concern across the pharmaceutical industry, prompting global regulatory actions and ongoing scientific dialogue. This article outlines a practical, risk-based approach to controlling nitrosamines throughout the product lifecycle—from initial risk identification and root cause analysis to implementation of effective control strategies incorporating continuous monitoring. Drawing on principles from ICH Q9 and Q10, the piece explores the use of advanced analytical tools such as GC-MS, LC-HRMS, and LC-MS/MS and highlights the importance of structure-activity relationship (SAR) modeling and in vitro and in vivo mutagenicity studies. Strategies for mitigation include process redesign, supplier controls, and integration into the pharmaceutical quality system (PQS). By fostering cross-functional collaboration and a culture of proactive quality, this approach not only meets evolving regulatory expectations but also advances pharmaceutical science and protects public health.