A pharmaceutical company approached Zamann Pharma Support because they needed a cost-effective and compliant strategy to manage nitrosamine risk assessment for their drug products. The company faced increasing regulatory pressure from FDA, EMA, and ICH M7 expectations. At the same time, they needed to avoid excessive analytical testing costs across multiple products and batches.
Therefore, Zamann Pharma Support proposed a structured nitrosamine questionnaire integrated into the Drug Product Risk Assessment (DPRA) process. The goal was to create a scientifically justified, regulator-ready approach that could identify true nitrosamine risks, reduce unnecessary testing, and support compliance through clear documentation and targeted decision-making.
We assist pharmaceutical teams in assessing and managing nitrosamines risks by aligning processes with ICH M7 requirements and current regulatory expectations.
Manufacturers can reduce testing costs by using a scientifically justified questionnaire within the DPRA process. If the assessment confirms the absence of amines, nitrites, and reactive process conditions, companies may justify a lower testing strategy while remaining aligned with FDA and EMA expectations.
Targeted testing usually becomes necessary when the formulation includes secondary or tertiary amines, nitrite exposure, acidic manufacturing conditions, reactive packaging materials, or storage environments that may support nitrosamine formation.
Regulators expect traceable documentation because questionnaire data supports the scientific rationale behind risk-based decisions. Clear records demonstrate that the company evaluated APIs, excipients, manufacturing steps, packaging, and storage conditions systematically within the DPRA lifecycle.
