The deadline may have moved, but the countdown still continues.
It’s good news for pharma companies that the deadline for risk assessment on nitrosamines has been extended to October 1st. However, with the shutdown of many sites due to the COVID-19 pandemic, that could still be a challenge for many.
The European Medicines Agency has now agreed to extend the deadline for the submission of risk evaluations to 1 October 2020. As before, MAHs are obliged to inform the national competent authorities as soon as possible if tests confirm the presence of nitrosamine, irrespective of the amount detected.
Based on this directive, now more than ever, it's imperative to choose a partner who is set up with a dedicated team, capability to work quickly and professionally within the new timeline, and with the correct expertise to properly conduct a risk evaluation which can identify active substances and finished products at risk of N-nitrosamine formation or (cross-)contamination.
Get in touch with us to learn how QUINTA-ANALYTICA can help with such testing using our isotopically labeled standard detection methods for APIs, solid dosage forms, solutions for infusion, oral solutions, semi-finished products and more.
April 14, 2020