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 the analysis of quantification of impurities is doing?
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
Demonstrated national and international experience with more than 1.000 reports developed
ICH Q3D guideline for Elemental Impurities
Lifecycle Management: maintenance of the toxicological report throughout the entire product lifecycle involving all it steps: