Nitrosamines in active substances and finished medicinal products

EMA strongly requests the risk-based proof that active substances and finished medicinal products are free of nitrosamines. Are you prepared for this?

Nitrosamines can have carcinogenic and mutagenic properties and were detected first in 2018 in higher concentrations in “sartan”-containing medicinal products. In subsequent developments, nitrosamine impurities were identified in further medicinal products and active substances. Consequently, the EMA and national competent authorities obliged marketing authorization holders of all human medicines to review their products for possible nitrosamine contaminations. All market authorization holders for active substances and finished medicinal products have to report the outcome of a risk assessment for chemical medicines by 31 March 2021 and for biological medicines by 1 July 2021.

Valicare GmbH with its multidisciplinary team of pharmacists, chemists, biologists and engineers has successfully been providing technical and process-oriented risk analyses for all phases of pharmaceutical product cycle for many years, and in particular also with regard to possible nitrosamine contamination.

Since recently, Dr. Carsten Börger strengthens the valicare team in his function as Senior GMP Consultant and contributes his long-term expertise in this field.

He has over ten years of experience in low-molecular-weight active substances, thereof the last five years in GMP regulated environment. Further key aspects of his expertise are the development of new bioactive molecules and the development of synthetic routes for APIs including quality control. As former head of production of an API manufacturer he is our expert who can also support and advice at your side.

For more information on this topic, have a look on the research: "Nitrosamines in active substances and finished medicinal products." written by Dr. C. Börger

Infos about our Risk Management and Risk Analysis services you get here.

And please call us if you have questions or need support.

Author: Dr. C. Börger, Senior GMP Consultant, Valicare