The FDA releases revision of guidance regarding Control of Nitrosamine Impurities in Human Drugs

What’s new?

Here are the key updates on the FDA’s revision of the guidance on controlling nitrosamine impurities:

• Renewed focus on Nitrosamine Drug Substance-Related Impurities (NDSRIs): The FDA, aligning with EMA’s strategy, now emphasizes the need to assess not only just small-molecule nitrosamines but also potential NDSRI formation.
• Broader root cause analysis: Expanded causes of nitrosamine formation, with new mitigation strategies like using antioxidants to prevent NDSRI formation.
• Updated Acceptable Intake (AI) limits: Based on the Carcinogenic Potency Categorization Approach (CPCA), including AI limits for drug products at risk of forming NDSRIs and detailed testing recommendations.
• Three-step mitigation strategy: Similar to the EMA’s approach (steps 1, 2, and 3) is now recommended for manufacturers and applicants.
  
  

What does this mean to you?

Ongoing risk assessments are now mandatory, with updated safety testing and reformulation strategies to prevent nitrosamine formation. This means that companies must be vigilant in monitoring their products for potential risks and take proactive steps to ensure consumer safety. 

How can QbD Group assist you?

Our expert team toxicologist is here to guide you through regulatory changes and ensure your Nitrosamine Risk Assessments are up-to-date and compliant.