Zamann Pharma Support offers specialized services to perform an in-depth Nitrosamines GAP Assessment to evaluate your company’s alignment with ICH M7 and FDA regulations. Our experts carefully review all implemented risk management strategies, procedures, and control measures to ensure that your nitrosamine-related processes are compliant with the latest global standards. Through structured analysis and documented insights, we highlight deficiencies, regulatory misalignments, and improvement opportunities. Our deliverables include actionable recommendations that not only close compliance gaps but also strengthen your organization’s risk control framework and readiness for audits, inspections, and long-term regulatory expectations.
A thorough Nitrosamines GAP Assessment starts with a full-scale documentation review to examine how well your current procedures support nitrosamine compliance. We analyze standard operating procedures (SOPs), internal risk control guidelines, validation documents, and product lifecycle records for completeness and regulatory alignment. Each reviewed document is checked against ICH M7 and FDA requirements to confirm its relevance, traceability, and accuracy. Our assessment helps clients understand whether existing documentation adequately covers nitrosamine impurity management or if revisions are needed. The goal is to ensure that your documentation package stands up to regulatory scrutiny and inspection demands.
In this phase of the Nitrosamines GAP Assessment, we focus on evaluating the scientific quality and regulatory adequacy of your risk assessment approach. We analyze the methodologies you use to identify, score, and prioritize nitrosamine contamination risks across products, processes, and suppliers. Our review covers toxicological data sources, decision-making logic, exposure calculations, and control thresholds. We compare these practices with ICH M7 and FDA expectations, offering clear, evidence-based feedback on compliance status. The analysis provides a foundation for enhancing risk models and refining your nitrosamine control strategy to better support long-term product safety.
Our Nitrosamines GAP Assessment culminates in a comprehensive compliance review to detect any missing or insufficient elements in your current strategy. We map your risk framework against ICH M7 and FDA standards, identifying specific areas where your documentation, risk assessments, or controls fall short. Whether the issue is lack of traceability, outdated procedures, or unvalidated controls, we document each finding clearly and suggest targeted corrective actions. The result is a complete remediation plan with prioritized steps for closing gaps, reducing regulatory exposure, and ensuring continuous improvement in your nitrosamine management program.
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.
