Overview
Nitrosamine impurities have been a pressing topic in the pharmaceutical world ever since their detection in a commonly used blood pressure medication in 2018, In the last 3 years, several regulatory warnings and product recalls have been issued due to contamination with this class of genotoxic impurities.
Global regulatory authorities including the FDA and the EMA have introduced major regulatory updates instructing all pharmaceutical manufacturers to conduct a risk assessment and proactively test their products for nitrosamine contamination.
As a result, marketing authorization holders of human medicines identified to be at risk of N-nitrosamine formation had until March 31 2021 to complete the risk assessment followed by confirmatory testing and submission of required changes by September 26, 2022 (EMA), October 1, 2022 (HC) and October 1, 2023 (FDA).
It’s therefore crucial for pharmaceutical companies and manufacturers to get up-to-speed with these new requirements.