Pharmaceutical Industry Practices on Genotoxic Impurities

A great deal of confusion and uncertainty over genotoxic impurity (GTI) identification, assessment, and control exists. This book strives to facilitate scientific and systematic consensus on GTI management by presenting rationales, strategies, practices, and case studies from the pharmaceutical industry. Exploring the safety, quality, and regulatory aspects of GTIs, the text explains the how and why of various GTI control tactics and practices, including GTI control examples in drug substance and drug product development processes from large and small pharmaceutical firms in multiple geographical regions.