NITROSAMINE IMPURITIES (Risk, Regulation & Mitigation Explained)
Автор: Prashant Sir official
Загружено: 2025-08-07
Просмотров: 380
#Nitrosamines #PharmaceuticalSafety #DrugImpurities #GMP #RegulatoryCompliance #RiskAssessment #ValsartanRecall #FDA #ICHGuidelines #PharmaQuality
Nitrosamine Impurities in Pharmaceuticals – What You Need to Know
In this video, we dive deep into the critical topic of nitrosamine impurities in drug substances and products. Nitrosamines are potent carcinogens that have raised global concern in the pharmaceutical industry, leading to major recalls and updated regulatory guidelines.
🔍 Topics Covered:
What are Nitrosamines?
Why they are a concern for public health (carcinogenic potential)
Historical incidents – e.g., Valsartan recalls
Common sources of nitrosamine contamination
Steps in risk assessment
A practical risk assessment questionnaire
Mitigation strategies for manufacturers
Overview of the regulatory framework (FDA, EMA, ICH M7, etc.)
📌 Whether you're a pharma professional, quality assurance expert, or regulatory affairs specialist, this video gives you the foundational understanding you need to manage nitrosamine risk effectively.
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