Hi all,
Just today, EFPIA released a new version (v03) of the Workflow for Quality Risk Management regarding nitrosamine evaluation.
efpia-nitrosamines-risk-management-workflows-jun-24-udpate.pdf
Highly recommended lecture around best practices to address the nitrosamine topic for drug substance and drug product.
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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.
