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Zamann Pharma Support GmbH offers specialized consulting services tailored to help companies meet evolving Nitrosamines requirements under ICH M7 and international regulations. Our focus lies in delivering comprehensive assessments, strategy development, and implementation support that enables pharmaceutical companies to proactively manage the risks associated with Nitrosamine impurities. With in-depth regulatory knowledge and real-world application experience, we guide clients through practical measures to enhance compliance, minimize contamination risks, and improve overall product safety. Our structured, lifecycle-based approach ensures sustainable compliance while integrating best practices into manufacturing and quality processes for long-term regulatory readiness.
Meeting Nitrosamines requirements begins with identifying potential sources of contamination through structured risk assessments and GAP analyses. We analyze pharmaceutical product compositions, raw materials, packaging interactions, and manufacturing workflows to detect where Nitrosamines may form or enter the product lifecycle. Our team evaluates current control mechanisms, sampling procedures, and monitoring frequencies to assess whether they sufficiently mitigate risk. We then provide corrective and preventive recommendations tailored to the findings. This includes process changes, material substitutions, and new testing methods to close compliance gaps and ensure consistent adherence to safety and regulatory standards.
Once risk profiles are defined, we partner with clients to create tailored Nitrosamine control strategies in line with Nitrosamines requirements and ICH M7 guidelines. This process includes designing detailed lifecycle strategies that encompass impurity monitoring, control thresholds, response protocols, and supplier qualification procedures. We also define specifications for in-process controls and establish communication pathways between quality, R&D, and production teams. The resulting framework enables organizations to proactively manage regulatory risks while maintaining operational agility. Our strategy development ensures regulatory alignment while embedding a strong culture of Nitrosamine risk management throughout the product lifecycle.
Achieving and maintaining compliance with Nitrosamines requirements requires practical implementation and trained personnel. Our consultants provide hands-on support during every step of the strategy rollout. We guide process adjustments, equipment validations, and documentation updates, ensuring they reflect the latest risk data and regulatory requirements. Additionally, we design and deliver training sessions tailored to each department’s role in Nitrosamine control, empowering teams to confidently execute tasks. Our support extends to building internal monitoring systems, establishing audit trails, and preparing companies for inspections—all essential for continuous compliance and operational 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.
