Zamann pharma posted blog about updates in regulation of nitrosamine impurities.
Conclusion: A Global Effort to Ensure Drug Safety
The FDA, EMA, and TGA are leading the charge in addressing nitrosamine contamination. Their updated regulatory frameworks are designed to ensure that medications remain safe, effective, and free from unacceptable levels of carcinogenic impurities.
Pharmaceutical manufacturers must stay informed, implement risk-based strategies, and comply with new testing and monitoring requirements to meet evolving regulatory expectations.