Avoid unnecessary testing: Achieve confident ICH Q3D compliance using regulatory aligned consortium data
Approaching regulatory compliance with confidence ICH Q3D guidelines require assessing and controlling elemental impurities for regulatory compliant development of drug products. The workflow emphasises a risk-based control strategy to limit elemental impurities, which can be derived from residual catalysts, raw materials, reagents that can be present in the API or excipient of the drug product. […]
