ICH Guideline Q3D (R2) on Elemental Impurities

On 3 May 2022 the EMA published step 5 of the revised ICH guideline Q3D (R2) on elemental impurities.

This guideline 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.

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