E17: Impurities in Pharmaceuticals – A Survey Course

One-Day Course

Dr. Bernard A. Olsen, Olsen Pharmaceutical Consulting, West Lafayette, IN

This one-day course will provide information on a wide variety of impurities that may be present in small molecule drug substances and drug products.  Each impurity topic will include a discussion of regulatory expectations, analytical considerations and method development, specifications, and strategies for addressing impurities throughout drug development.  A special emphasis will be given to the ICH M7 guideline on genotoxic impurities and the ICH Q3D guideline and USP general chapter <232> and <233> requirements for elemental impurities.  Other specific topics to be covered include related substance process impurities, other synthetic process impurities, degradation products, excipient impurities and interaction products, stereochemical impurities, residual solvents, inorganic impurities, extractable and leachable impurities, and solid state forms.To get the most out of the course, we highly recommended that you have at least two years of pharmaceutical analysis or drug development experience.

This one-day course will benefit chemists, engineers, formulation scientists, regulatory and quality personnel, and others in the pharmaceutical industry who would like to obtain an increased understanding of issues involved with drug impurities and how to address them.

1.  Process Related Impurities in Drug Substances
* ICH guidelines, impurity qualification, impurity reporting
* Impurity origins, control, specifications
2.  Degradation Impurities in Drug Substances and Drug Products
* ICH guidelines, specifications
* Forced degradation studies
* Excipient interactions
3. Analytical Method Considerations for Impurity Investigation and Control
* Screening methods
* Control methods
4.  Chiral Purity
5.  Residual Solvents
6.  Genotoxic Impurities
* ICH M7 guideline
* Assessment of impurities for genotoxicity
* Analytical considerations for trace impurity determination
7.  Inorganic Impurities
8.  Elemental Impurities, ICH Q3D, USP <232>, <233>
9.  Extractables and Leachables
10. Solid State Forms

Dr. Bernard A. Olsen
has over 29 years of experience at Eli Lilly and Company related to chemistry, manufacturing and control aspects of drug substances and drug products. He has contributed to the development and support of over 25 commercial drugs and numerous developmental drugs. He currently provides consulting services to the pharmaceutical industry and serves as Chair of the USP Expert Committee on Monograph Development-Small Molecules 3. He has published and given invited lectures on a wide array of drug development and analytical topics including high performance liquid chromatography, impurity determination and control, genotoxic impurities, physical property characterization, drug counterfeiting, regulatory aspects of drug development, and quality control. His undergraduate degree is from Nebraska Wesleyan University and his doctorate in analytical chemistry is from the University of Wisconsin-Madison.  He is a Fellow of the American Association of Pharmaceutical Scientists.