The deadline has been extended to October 1st, but the countdown still continues.
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.
19 December 2023
Happy new year 2024
As we bid farewell to 2023, it's time to express our deepest gratitude for the collaboration.
4 December 2023
Our new clinical unit in Ostrava comes to life
It's a great pleasure to announce that after two years of hard work, the brand-new clinical unit in Ostrava with 36-beds capacity has been opened.
3 October 2023
Meet us at the heart of Pharma, CPHI 2023
Quinta-Analytica is attending CPHI 2023 in Barcelona