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 right 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:
- ICH Q3A and ICH Q3B for organic synthesis and/or degradation impurities
- ICH M7 for assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk
- ICH Q3D for Elemental Impurities
- EMA/CHMP/CVMP/QWP/199250/2009 for impurities in antibiotics
- Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food
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. The responsible person details the methodology and conclusions of this report upon delivery, and is available for any later question that may arise.