The presence of impurities in pharmaceutical products makes it difficult in many cases to release these pharmaceutical batches, which has a negative impact on the business of the companies concerned.
On occasion, an exhaustive toxicological evaluation of these impurities shows there is no risk to the safety and/or efficacy of pharmaceuticals and therefore, these batches will be qualified and able to reach the market.
Our team of experts design custom action plans, conisdering that:
- Our goal is to ensure that there is no risk
- The cost of the resources and technology used is lower than the cost of recalling the batch
- The report constitutes evidence for the Health Authorities: upon delivery of the report, the responsible person details methodology and conclusions, and is available for any later question that may arise.
- Guide for extractables and leachables: impurities that could migrate from the closure systems of pharmaceutical containers, process equipment and packaging to contaminate pharmaceuticals.
- ICH Q3D for Elemental Impurities intended to limit the presence of potentially toxic elemental impurities in drug products for human use.
- ICH Q3A and ICH Q3B for organic synthesis and/or degradation impurities: Those that come from the starting materials, the reaction intermediates or those produced by the degradation after synthesising them.
- EMA / CHMP / CVMP / QWP / 199250/2009 for Antibiotic Impurities including related substances, the residues of the producing microorganism, substrates, precursors and other ingredients as well as how they will be eliminated by subsequent purification stages.