In 2018, nitrosamine impurities were found in a number of sartans. This led to some product recalls and a regulatory review, which set strict new manufacturing requirements for these medicines. Subsequently, nitrosamine impurities have been detected in other products.
On 19 September 2019 the EMA published guidance (EMA/189634/2019) instructing marketing authorisation holders of all medicines containing chemically synthesised active substances to conduct a risk assessment to evaluate the possibility of nitrosamines being present in every concerned medicine within six months (i.e. by the end of March 2020). Companies will then have another 30 months to take mitigation measures where risks are identified, starting with the highest risk products. The authorities in Canada, South Korea and Switzerland have also issued similar instructions.
Let NSF help you get prepared. This webinar covers:
- The background to nitrosamines in products
- Active ingredient (API) risks
- Other contamination risks from water, solvents and cross-contamination
Watch the webinar here.
If you have any questions, contact NSF at pharmamail@nsf.org.
