About the Speaker:

Geoff Carr was appointed as  Manager, Analytical Development, at Patheon Inc., Ontario, Canada in 2000 and is now Director, Analytical Development, Canada. Prior to that, he held positions of Manager, Analytical Sciences at Celltech-Chiroscience, UK, Head of Analytical Development at Medgenix, Belgium and before that at Wyeth Research, UK. He originally started his career in pharmaceutical analysis at The British Pharmacopoeia Laboratory where he held several posts and was finally appointed Head of the Laboratory. He has been a member of various British Pharmacopoeia Committees, a UK representative to Committees of the European Pharmacopoeia, and member of USP Committees and is currently a member of the 2010-2015 Cycle USP General Chapters – Chemical Methods Expert Committee. He is the author of numerous papers and presentations at international conferences on various topics related to pharmaceutical analysis.

About the Lecture:  

ICH Guidelines Q3A(R2) and Q3B(R2) provide detailed information on how to report impurities in pharmaceutical drug substances and drug products and how to decide on suitable acceptable limits. Over the last four years new guidelines have been issued initially by European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) that require considerably stricter controls over impurities that are considered to be potentially genotoxic. The introduction of these guidelines is leading to completely new ways for designing analytical studies on impurities. This presentation will discuss:

·          The genotoxic impurities and how is it decided whether a new impurity should be considered to be a

·          potential genotoxin.

·          A review of the requirements of EMA and FDA guidelines.

·          Specification limits that are required to control these impurities.

·          Analytical methods that are available that are capable of  providing the required controls.

The implications to a pharmaceutical development program.