Genotoxic Impurities Strategies for Identification and Control

This book examines the implications of the 2006 EMEA guidelines covering limits for genotoxic impurities and its impact on the pharmaceutical industry. The book explores the development of the guideline, the principles from which it was derived, and the uncertainties surrounding its application. Specific sections examine this from both a toxicological and analytical perspective. Within these sections, the book defines appropriate strategies to both assess and ultimately control genotoxic impurities, thus aiding the reader to develop effective control measures. In the final section, the book challenges the actual basis of the guidance itself and its appropriateness with a view to contribute to the debate and future refinement of guidance within this arena.

Andrew Teasdale, PHD, is a senior QA executive with AstraZeneca and chairs the company's internal genotoxic impurities advisory group. With over fifteen years of experience in analytical chemistry and quality assurance, Dr. Teasdale has published a number of papers relating to GIs and has been a speaker on genotoxic impurities at a number of conferences. Dr. Teasdale has also led two expert groups working in the field of genotoxic impurities, including an analytical group in the UK and a Project Quality Research Institute [PQRI] working group, which focused on the critical area of sulfonate ester formation and control.