Over the last few months nitrosamines (particularly NDMA and NDEA) have come under increased scrutiny from regulatory authorities, such as the FDA and EMA.
Nitrosamines were found at levels considered to be harmful to human health in sartan drug products. This is as a direct result of the chemistry used by certain manufacturers.
As a result, the EMA has requested that relevant manufacturers evaluate their products for nitrosamines. This means testing all authorised human medicinal products containing chemically synthesized active pharmaceutical ingredients, including generics and over the counter products.
The EMA has requested that companies perform risk assessments using FMEA (as per ICH Q9) on their products over the next 6 months. The outcome must then be reported to the EMA.
High-risk products must be tested. Any detected nitrosamine levels must then reported immediately. If changes to manufacturing processes are deemed necessary, they should be completed within 3 years.
For more information on the nitrosamines and the pertinent EMA regulation, contact Hall Analytical: Contact@hallanalytical.com. We will support all of of your testing requirements.