In recent years, multiple drug products (DPs) have been recalled following the discovery of nitrosamine impurities. Consequently, regulators and the pharmaceutical industry are working hard to identify sources of nitrosamine impurities.
The latest US Food and Drug Administration (FDA) guidance from 2020 lists at least seven potential root causes, while the most recent guidance by the European Medical Agency (EMA) lists eleven. The variety in the possible root causes makes accurate risk assessment a challenging proposition. In this white paper, we look at the challenges posed in regards to testing methodologies and the way in which to move forward to ensure safer DPs.
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