Zamann Pharma Support offers expert-led Nitrosamines strategic consultancy services to help pharmaceutical companies build or improve their compliance frameworks in line with ICH M7 and FDA requirements. Our support includes end-to-end guidance on SOP development, risk assessments, mitigation strategies, and documentation standards specific to Nitrosamines. We also evaluate existing procedures and provide enhancement plans tailored to each client’s risk profile and operational context. Our objective is to ensure every client is equipped with the necessary tools, structure, and knowledge to maintain long-term regulatory compliance while reducing risk associated with nitrosamine impurities in drug products.
A solid foundation is essential for managing Nitrosamines, and our team works closely with clients to build one. We develop comprehensive documentation tailored to your products, regulatory exposure, and internal quality systems. This includes creating SOPs for impurity analysis, risk assessments, sampling protocols, and analytical testing methods specifically for Nitrosamines. We also design internal templates and guidance documents to standardize practices across departments and facilities. Our documentation package is inspection-ready, scalable, and aligned with current ICH M7 and FDA guidelines—ensuring clarity, consistency, and regulatory credibility from day one of implementation.
Our Nitrosamines consultancy includes a thorough GAP analysis of your current quality and risk management systems. We evaluate manufacturing workflows, analytical processes, and existing risk control strategies to identify where nitrosamine contamination could occur. Our assessment highlights procedural weaknesses, outdated controls, or missing documentation that may affect compliance. Once gaps are identified, we offer actionable recommendations—including process updates, SOP enhancements, and risk management improvements—to close compliance risks and improve data traceability. This proactive approach reduces future remediation efforts and supports ongoing regulatory alignment and internal operational excellence.
Long-term control of Nitrosamines requires more than technical solutions—it needs a structured and achievable implementation strategy. We help clients build a strategic roadmap that defines compliance goals, assigns responsibilities, and tracks key performance indicators (KPIs). Whether launching a new nitrosamine control program or improving an existing one, our consultants work collaboratively to identify training needs, establish reporting workflows, and ensure resource alignment. Each plan is tailored to the client’s maturity level and business model. The result is a transparent, accountable approach that enables continuous improvement and long-term ICH M7 compliance.
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.
