EPR Podcast Episode 26 – Navigating Nitrosamine Impurities – Jason Brown, Adare Pharma Solutions

This episode covers the emergence of nitrosamine impurities in the pharmaceutical industry and what action is being taken to address it, including the latest guidance, across pharma companies as well as regulators.

Addressing nitrosamine contamination

Brown opens the conversation by summarising the current landscape of nitrosamine impurities since the initial discovery around five years ago. He explains that industry response has continually evolved, due to new data being released and informing best practice for companies looking to mitigate and prevent formation of these impurities in medicines.

He explains that last year, the issue of nitrosamines moved from a toxicological problem to a wider industry concern. Now, “we are starting to get a good idea of how many products on the market could be affected”.

When it comes to preventing nitrosamine formation in drug products, key challenges manufacturers are facing include knowing exactly what active pharmaceutical ingredients (APIs) can form nitrosamines, Brown explains. He specified that there is a lack of alignment on this issue between regulatory agencies and experts.

Another major challenge is getting through the initial risk assessment for nitrosamines. There is still a “fundamental lack understanding…what exactly should be included in that risk assessment, and what it looks like,” Brown asserts, highlighting the importance of an inclusive risk assessment.

Having the right laboratory standards, equipment and personnel who are adequately informed is important in working to address the issue, Brown continues.

He also shares how technologies are “critical” to detecting nitrosamine impurities and recommends the best approaches in this area. Furthermore, he emphasises the importance of collaboration, spanning decisions made in quality to regulation, as well as considerations for reformulation strategies.

Finally, Jason looks ahead to the future and suggests how the industry can work to navigate nitrosamine impurities, for instance, over the next five years.