ICH Q3D Elemental impurities

This document presents a process to assess and control elemental impurities in the drug product using the principles of risk management as described in ICH Q9. This process provides a platform for developing a risk-based control strategy to limit elemental impurities in the drug product.

Please note that new/revised guideline sections are to be included in the Revision 2 of the guideline (see further down).

Keywords: Elemental impurities, limit, safety, routes of administration, toxicity, permitted daily exposure (PDE), risk assessment, control, specification, analytical

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