The U.S. Food and Drug Administration (FDA) has updated its guidance on the control of nitrosamine impurities in human drugs. The new guidance provides recommendations for manufacturers on how to detect and prevent nitrosamine contamination.
Key points from the updated guidance:
- Risk assessment should be conducted for all chemically synthesized and biological APIs
- Confirmatory testing should be performed if risk assessment identifies a potential risk
- Changes to manufacturing processes may be needed to mitigate risks
For more information, please visit the FDA website or contact our technical team.