EMA publishes implementation strategy for ICH Q3D
The European Medicines Agency (EMA) has published a guidance document to enable the practical implementation of the ICH Q3D Guideline for Elemental Impurities in the EU.
ICH Q3D came into force for new products in June, introducing a risk-based approach to the control of elemental impurities in the finished dosage form, taking into account potential sources such as the active pharma ingredient (API), excipients, manufacturing equipment, processing aids such as catalysts or water and container closure systems. It will be extended to include established products in December 2017.
The new document is "intended to provide guidance for applicants/MAHs, drug product, drug substance and excipient manufacturers, as well as regulators," says the EMA. It covers the different approaches to risk-management – i.e. focusing on the drug product or the components or a combination of the two at the manufacturer’s discretion – and provides additional information on intentionally-added elements as well as the dossier requirements and assessment strategy.