Update: EFPIA workflows for Quality Risk management Jun 2024 v03

Hi all,

Just today, EFPIA released a new version (v03) of the Workflow for Quality Risk Management regarding nitrosamine evaluation.


Highly recommended lecture around best practices to address the nitrosamine topic for drug substance and drug product.


Thank you for sharing the information, @Diego_HM. New version has replaced Ames test with EAT. And CPCA approach is included in AI calculations. We should carefully review details!!

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I applaud EFPIA’s efforts to clarify and address the challenges of Risk Assessment. #NoDeclarationLetter without data!

It’s great to see Guidance 6 (Can the N-nitrosamine be formed?), which provides comprehensive experimental conditions for reactivity assessment and formation of Nitrosamines.