Chemistry and Risk Assessment of N-nitrosamines with Focus on Drug Product and Elastomeric Primary Packaging Components
Since their discovery in June 2018, nitrosamines have received a lot of attention amongst global pharmaceutical industry. Recent decisions from regulatory bodies involve the development of a risk assessment and a possible reduction and control of nitrosamines in the final drug product by the marketing authorization holder. Now, we have all been allowed extra time for the preparation of the risk assessment for the EDQM. But still, this topic is quite complex and there are several open questions.
In this webinar, we want to address some of the open questions, for example, how can we account for the specific chemistry of nitrosamines in the risk assessment and how play elastomeric components a role here?
This and more will be covered both from the perspectives of a pharmaceutical company as well as a rubber component supplier.