At Veeprho we offer services of Genotoxic impurities assessment to avoid FDA queries. These assessments will help you to set impurity limits in your final specification of products. If you know the class of Impurity as per M7 guidelines, then you can increase and decrease limits in the specification.
We are using an FDA-approved tool that is Computer Assisted Control Strategy for Genotoxic & Nitrosamine impurities, in line with the requirement of ICH M7 & FDA guidance.
If your Drug Manufacturing Process involves highly reactive reagents, their reactivity can lead to mutagenic process impurities, in case they are not removed efficiently. We can support the precise assessment of the removal of such material using computer-assisted tools. This tool can also be used for de-risking the formation of nitrosamine impurities.
M7 guideline for control strategy of process-related impurities
The M7 guideline defines the approach for the control strategy of process-related impurities and recommends understanding the process parameters and impact on residual impurities. This includes performing fate and purge assessments with sufficient confidence that the level of impurity in the final drug substance will be below the acceptable limit, eliminating the need for analytical testing. Likewise, the FDA guidance document recommends a similar mitigation strategy for the presence of nitrosamine impurities in API.
The fate and purge assessments involve the application of an understanding of the physicochemical properties of an impurity in relation to the reaction and subsequent purification conditions to which it is exposed.
A computer-assisted tool allows for a rapid, reproducible semi-quantitative measure of these risk assessments of mutagenic impurities, including Nitrosamine.
The Final Assessment Report includes:
- The purge calculation.
- Scientific rationale.
- Computational toxicology.
- Supporting evidence to aid in the submission to regulators.
The assessment report can save substantial amounts of time and resources without increasing the risk to patients.