N-nitrosamines are classified as probable human carcinogens, necessitating that drug substance and drug product manufacturers implement measures to reduce or prevent nitrosamine impurities in APIs and drug products. This requires comprehensive risk assessments to evaluate nitrosamine levels and implement effective mitigation strategies.
Several factors contribute to nitrosamine formation or contamination, including the presence of nitrites in excipients, which pose risks when combined with vulnerable amines during manufacturing and storage. This presentation will offer insights into nitrosamine impurities, updates on regulatory expectations, and the critical role of excipients in assessing nitrosamine risks in pharmaceutical products.
In this webinar, you will learn about:
- nitrosamine impurities
- updates on regulatory expectations
- role of excipients in risk assessment
Speaker
Saroj Varavadekar
Merck
Head of Regulatory Management, India, Life Science
Saroj Varavadekar is head of regulatory management, India at Merck. Her current responsibilities include monitoring regulatory trends, commenting on guidelines, and representing Merck at authority events and meetings. She has 10+ years experience in R&D, product management & regulatory management. She holds a Ph.D. in biotechnology from Institute of Chemical Technology.
Pharma and biopharma manufacturing
- Pharma and biopharma manufacturing
Duration:1h
語言:English
會話 1:提出 November 19, 2024
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