TOXICOLOGICAL EVALUATION OF ORGANIC IMPURITIES
Minimize organic impurities to improve the safety of your product – and to avoid recalls.
Impurities in pharmaceutical products are unwanted substances without any therapeutic effect. Their origins vary from starting materials over manufacturing processes to aging APIs and formulations.
In any case, their presence can endanger the safety and efficacy of your pharmaceutical product. As a result, the manufacturer must justify any impurity if it reaches or exceeds the threshold level in a medication.
Additionally, cases like the recent European Valsartan Recall show the commercial risk of impurities that aren’t properly assessed and evaluated: recalls and batch rejections are actually more expensive than investing into proper impurity characterization and implementing the best control strategies from the start.
With our multidisciplinary team of experts, we identify impurities, perform a toxicological assessment, and assess the risks so we’re able to recommend and implement suitable control strategies whenever necessary.
We consider various EU guidelines in our evaluation, the most important of them being:
The results of our evaluations can be applied in multiple ways: for instance, your R&D will receive a tool to improve the manufacturing processes, while your Qualified Person gains a scientific base for the decision of batch release with respect to impurities.
We also provide you with the comprehensive documentation required for all GMP relevant processes. Our final report can be used as evidence for the Health Authorities.
