What is ICH Q3D?
ICH Q3D Guideline is focused to limit the presence of potentially toxic elemental impurities in human medicines.
At Azierta, we are experts developing toxicological reports and we have a data base with more tan 1.500 excipients and APIs.
How is the risk analysis of elemental impurities carried out?
We perform the Risk Assessment of each impurity to implement the ICH Q3D guideline following an exhaustive methodology:
- Impurity identification and data recopilation
- Strategy management
- Risk Assessment
- Impurity level assessment
- Implementation of control measures
- Toxicological report development
Azierta Elemental Impurities Support - ICH Q3D
Lifecycle Management: We perform maintenance of the toxicological report through the entire product lifecycle, support throughout all the steps. "
Toxicological support composed of a multidisciplinary team of toxicologists and chemical experts accredited by AETOX, EUROTOX and ERT