Nitrosamines in Pharmaceuticals: What are your options as October 1, 2020 approaches?
Risk assessments for genotoxic impurities have been performed in the pharmaceutical industry for many years. However, after finding nitrosamine impurities in Valsartan drug products in 2018, these specific impurities became a subject of concern for health authorities (FDA, Health Canada, EMEA). Further investigation work led Authorities to extend the risk to find nitrosamines to many other molecules (such as Metformin, Ranitidine and all other Sartan products, to name a few), and searches continue. A risk assessment for nitrosamines is now required by MAHs for all their marketed drug products.
In a constantly changing situation, it is sometimes hard to choose the right strategy to perform a proper risk assessment. This presentation will provide you some key concepts for a better understanding of the situation and case studies to help you make your decision.
To watch the webinar, simply fill out the form on the right.
- -What are Nitrosamine impurities?
- -The Valsartan Issue
- -FDA Recall History
- -Current Regulatory Situation
- -Analytical Strategies and Options
- -Case Studies
About the Presenter
Mathieu Fournier, M.Sc., Director, R&D and Scientific Affairs, Neopharm Labs
Mathieu Fournier presently serves as Director, R&D and Scientific Affairs at Neopharm Labs. This challenging role allows him to apply his global knowledge and expertise of analytical chemistry in the pharmaceutical industry to meet the evolving business demands of various customers from the life sciences industry.
Mathieu has over 15 years of experience in applied research & development within the pharmaceutical industry. Over the course of his career, he has managed new method development projects for oral dosage forms, ophthalmic solutions and injectable products. These projects have enabled him to develop a solid expertise in method development and validation, as well as in forced degradation and dissolution studies, reverse engineering and process automation. He is also experienced in providing answers to health authorities as a subject matter expert.
Mathieu also worked on commercialized drug products for analytical troubleshooting, source changes, site changes and monograph updates. His background in mass spectrometry (GC/MS and LC/MS) brought him to develop an expertise to conduct complete extractables & leachables studies for various packaging systems. He has also acquired an in-depth knowledge to perform risk assessments for genotoxic impurities (like nitrosamines) and for the identification of unknown peaks. More recently, he extended his knowledge to ICP-MS by leading projects for the method development of elemental impurities determination as per ICH/USP new guidelines.
Mathieu holds a Master of Science degree in Analytical Chemistry, specializing in small molecule analysis by LC/MS from the Université du Québec à Montréal (UQÀM).