Ensure the safety and compliance of your pharmaceutical products with X Pharma Plus Our expert services evaluate and mitigate nitrosamine-related risks in line with global Regulatory expectations, helping you maintain product quality and meet Health Authority requirements efficiently.
Nitrosamine Impurity Risk Assessment – Overview
Nitrosamine impurities have become a critical focus for Regulatory authorities worldwide due to their potential health risks. Pharmaceutical companies must conduct rigorous risk assessments to identify and mitigate the presence of nitrosamines in medicinal products. Health Authorities such as the US FDA, EMA, MHRA, Health Canada, PMDA, and TGA emphasize the importance of addressing nitrosamine impurities to ensure product safety.
The USFDA recently issued final guidance on Nitrosamines Drug Substance Related Impurities (NDSRIs), which focuses on nitrosamines structurally related to Active Pharmaceutical Ingredients (APIs) and often lacking mutagenicity and carcinogenicity data.
This guidance highlights:
- Prediction of mutagenic and carcinogenic potential of NDSRIs.
- Recommended Acceptable Intake (AI) limits using the Carcinogenic Potency Categorization Approach (CPCA).
- Alternative approaches for justifying higher AI limits and interim AI assignments for marketed products.
- Timelines for confirmatory testing and required changes in drug applications.
Regulatory specifics can vary across countries, and ongoing scientific research may lead to updates in risk assessment approaches and guidelines.
At X Pharma Plus, we specialize in Nitrosamine impurity risk assessment, offering comprehensive services to support pharmaceutical and biotechnology manufacturers in this critical area.
Our expert Regulatory team provides in-depth guidance on:
- Global Regulatory requirements and evolving guidelines.
- Risk assessment, mitigation strategies, and documentation preparation.
- Ensuring product safety, quality, and compliance across international markets.
With X Pharma Plus, navigate the complexities of nitrosamine risk management confidently while maintaining Regulatory compliance.
Nitrosamine Impurity Risk Assessment
“Nitrosamine Impurity Risk Assessment involves identifying, evaluating, and controlling potential nitrosamine risks in drug products to ensure patient safety and regulatory compliance.”