Zamann Pharma Support provides specialized consulting services to support the creation of a risk management strategy for nitrosamine drug product compliance. Our service ensures pharmaceutical companies meet ICH M7 and FDA guidelines while building a scientifically justified, inspection-ready approach. We assist in designing internal policies, drafting SOPs, and developing risk-based controls specific to drug products where nitrosamine contamination poses a critical concern. Our experts guide clients through end-to-end planning—from impurity identification to regulatory documentation—helping ensure long-term control, reduced product risk, and confidence during health authority reviews and market audits.
Our approach to nitrosamine drug product risk assessment begins by creating a robust and structured framework for evaluating potential nitrosamine impurities. We define hazard identification methods, establish evaluation criteria, and guide the development of decision trees and scoring tools. This systematic framework enables companies to identify vulnerable stages of their manufacturing process—from excipient interactions to degradation pathways—where nitrosamines may form. We ensure every factor, from dose calculations to storage conditions, is accounted for in a data-driven format. This enables pharmaceutical teams to document, track, and prioritize risks in alignment with international regulatory expectations.
After risks have been identified, we work collaboratively to design and implement mitigation plans specific to each nitrosamine drug product. These include manufacturing adjustments, reformulations, validated analytical methods, supplier qualification criteria, and contamination control procedures tailored to the formulation type. We support the integration of mitigation measures into existing GMP systems and help revise quality documentation to reflect changes. Our strategies are pragmatic and scalable, ensuring both new and legacy products are covered. By embedding these strategies into lifecycle documents and procedures, clients gain confidence in risk minimization and long-term process stability.
To support a compliant nitrosamine drug product strategy, our consultants perform detailed GAP analyses of current quality systems and risk controls. We benchmark existing practices against ICH M7 and FDA expectations to identify documentation deficiencies, procedural gaps, or outdated strategies. Once gaps are identified, we develop clear remediation plans and assist with implementation, including QMS updates and training. Our goal is to help companies proactively close risks and maintain a high level of preparedness for audits or regulatory questions. This also positions the organization to efficiently manage future nitrosamine-related updates or findings.
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.
