Enhancing nitrosamines analysis: a focus on NDSRIs
Exploring the complexities of nitrosamines to enhance understanding and overall management, with a focus on nitrosamine drug substance-related impurities (NDSRIs).
About this on-demand webinar
For a long time in many different sectors nitrosamines have been, are and will continue to be a concern for human safety – and an essential impurity to be kept under control through risk assessment and management.
Over the last 15 years Mérieux NutriSciences have been working on nitrosamines in different sectors, such as cosmetics, packaging, tobacco and food.1 In 2019 the first nitrosamines alerts and related pharmaceutical products recalls led the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and other Competent Authorities to request that the pharma industries evaluate the risk of the presence of nitrosamine impurities in human medicinal products in a broader and more extensive way.2
Following the risk evaluation phase, we are now in the confirmatory test phase, in which it is important to have specific, selective and very sensitive analytical methods to adequately respond to the needs of the market and its regulations.3
This on-demand webinar provides an overview, at different levels, of the complex and articulated topic of nitrosamines. To enhance understanding and overall management, at the safety level our speakers combine the analytical and scientific aspects with the regulatory and assessment details. They particularly focus on emerging nitrosamines for the pharma industry: nitrosamine drug substance-related impurities (NDSRIs). Some case studies conclude at an analytical level.
- De Dominicis E, et al. A New and Sensitive Approach to Nitrosamines Residues in Food by LC-MS/MS. Poster Presentation, AOAC International, Boca Raton Florida USA, Sep. 2015.
- Committee for Medicinal Products for Human Use (CHMP) – European Medicines Agency. Nitrosamine impurities in human medicinal products. EMA/369136/2020. Jun 2020.
- EMA & CMPH. Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products. EMA/71101/2022. Jan 2022.
Learning outcomes of this webinar
- Regulatory framework updates
- NDSRIs: emerging issues
- Mérieux NutriSciences Nitrosamines Global Service: expertise and support for the root cause(s) identification beyond testing
- What about NDSRIs? Case Studies.
Emiliano De Dominicis, Chemistry Research Director, Mérieux NutriSciences
Emiliano is a researcher with over twenty years of experience in food and pharmaceutical safety, both in private and academic sectors, and he is now Director of Chemical Research – Project Manager at Mérieux NutriSciences. With a team dedicated to Research and Development in Analytical Chemistry, Emiliano is responsible for Mérieux NutriSciences R&D Lab and Global Research Projects. Moreover, Emiliano actively participates in funded scientific projects (regional, national and European), scientific congresses as a speaker and writes articles published in specialised scientific journals.
Sergio Fasan, Pharma Business Director, Mérieux NutriSciences
Sergio is currently Business Director of the Pharma, Healthcare and Cosmetics Business Unit at Mérieux NutriSciences Italy. He started the collaboration with Chelab 22 years ago and held different roles during that time, starting as Laboratory Manager and later acting as Quality Control Manager of the GMP Facility, Director of the GLP Facility and Business Unit Manager of the GxP Division at Mérieux NutriSciences Italy.