Zamann supports pharmaceutical companies in developing comprehensive nitrosamine management strategies aligned with current regulatory expectations, including ICH M7, EMA, and FDA guidance. Our approach provides the framework, documentation, and quality processes required to establish a sustainable, inspection-ready nitrosamine compliance programme.
We support the development of a comprehensive nitrosamine management strategy covering the complete medicinal product lifecycle. The strategy establishes standardized governance, scientific decision-making processes, responsibilities and documentation practices to ensure consistent compliance with ICH M7, EMA, FDA, and other applicable international guidance while providing a structured approach for future regulatory updates.
Zamann provides standardized Drug Substance and Drug Product Risk Assessment templates that follow a structured scientific methodology consistent with current regulatory expectations. The framework enables manufacturers to evaluate nitrosamine and NDSRI risks, document scientific justifications, assess manufacturing and supplier changes, and maintain risk assessments throughout the product lifecycle in accordance with ICH M7, EMA and FDA expectations.
Effective nitrosamine management requires integration into the Pharmaceutical Quality System rather than isolated documentation. Zamann supports the implementation of SOPs, work instructions, governance documents, templates and internal guidance that establish compliant workflows for risk assessment, change management, periodic review and lifecycle management while supporting inspection readiness.
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.
