Zamann Pharma Support offers specialized services for developing robust Nitrosamines Risk Assessment documentation within ICH M7 adaptation projects. Our focus is to support pharmaceutical manufacturers in identifying, analyzing, and prioritizing the risks related to nitrosamine impurities across product lifecycles. We provide end-to-end guidance, from data collection and hazard characterization to final documentation aligned with global regulatory expectations. With deep expertise in regulatory toxicology, manufacturing processes, and impurity control strategies, we help ensure your Nitrosamines Risk Assessment is scientifically sound, inspection-ready, and capable of supporting long-term risk mitigation planning and product safety assurance.
The foundation of a reliable Nitrosamines Risk Assessment is thorough, accurate, and traceable data collection. We gather detailed information from across your supply chain, including raw materials, intermediates, excipients, and final product formulations. Our consultants review manufacturing batch records, historical testing results, and relevant published literature to identify potential precursors or sources of nitrosamine formation. By leveraging structured templates and validated tools, we ensure all data is centralized, clean, and fit for toxicological interpretation. This process supports a well-informed, evidence-based approach to building a compliant and comprehensive Nitrosamines risk profile.
In this phase of the Nitrosamines Risk Assessment, our scientific experts identify and characterize the toxicological properties of detected or suspected nitrosamine impurities. Using globally recognized databases and regulatory toxicology references, we evaluate the genotoxic and carcinogenic potential of each nitrosamine based on available data. Dose-response relationships, systemic exposure, and route-specific impacts are carefully considered to understand real-world patient risk. This enables us to define safety thresholds and permissible exposure limits in line with ICH M7. The result is a scientifically credible hazard profile that informs subsequent control decisions and regulatory submissions.
The final phase of our Nitrosamines Risk Assessment process involves detailed risk evaluation and prioritization. We quantify the likelihood and severity of nitrosamine presence using predictive modeling, analytical data, and process risk mapping. Risk scores are assigned to each identified source, allowing clear prioritization of mitigation efforts. Our goal is to align risk control with patient safety expectations and compliance mandates. We present this analysis in a structured report format that supports decision-making and enables the development of targeted, resource-efficient mitigation plans, while providing documented evidence for audits and regulatory reviews.
Our strategic approach to ensure Nitrosamine compliance is based on global and holistic experience, and can be perfectly adapted to your reality. We address the latest regulations and risk assessments, helping you manage and mitigate potential risks specific to your products and processes.
Zamann stays ahead of the evolving Nitrosamine requirements, providing expert guidance to ensure compliance with confidence. Our proactive and senior approach helps protect product integrity and patient safety, securing your operations against regulatory risks.
