The Impurities Forum Part II - Live Online Nitrosamines and other Mutagenic Impurities

In Part II of the Impurities Forum the relevant aspects of root cause analysis and risk assessment with respect to potential Nitrosamine contamination in drug substances and drug products will be discussed. You will hear what you need to know about the required risk assessments for medicinal products containing chemically synthesized APIs. In particular you will learn

You will get advice from industry experts on how to cope with the challenge of performing risk assessments. Furthermore a representative of the EDQM will inform you about the European Pharmacopoeia activities (policy) on mutagenic impurities with focus on Nitrosamines.

Mutagenic substances as impurities in drug substances or drug products are of big concern as they have the potential to alter or damage human DNA. Among these species Nitrosamines and elemental impurities have triggered various regulatory activities and initiatives. Since September 2019 Marketing Authorisation Holders are requested to evaluate the risk of the presence of Nitrosamine impurities in human medicinal products containing chemically synthesised APIs. In case of a contamination with Nitrosamines MAHs are requested to file a variation application. All regulatory activities with regard to such cases have to be completed within a 3 years period (end of March 2022). The ICH Q3D Guideline for Elemental Impurities was published as Step 4 document and has meanwhile been revised twice, regarding Cadmium Inhalation PDE and cutaneous and transdermal products.