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ICH Guidance: Q3D(R2) ELEMENTAL IMPURITIES

Recently the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) released the (Finalised) updated Q3D(R2) Elemental Impurities.

A drug product can contain elemental impurities that may originate from a number of sources, including residual catalysts, added deliberately during synthesis or impurities present in components of the drug product (e.g., by interacting with processing equipment or container/closure systems).


This guidance can be segmented into 3 parts:

  1. The evaluation of the toxicity data for potential elemental impurities

  2. The establishment of a Permitted Daily Exposure (PDE) for each element of toxicological concern

  3. The application of a risk-based approach to control elemental impurities in drug products

This guidance describes how we can assess and control elemental impurities in a drug product using the principles of risk management, as described in the ICH guidance for Q9 Quality Risk Management for the industry.


The guidance applies to new finished drug products, drug Substances, and new drug products containing existing drug substances. The drug products containing purified proteins, polypeptides, and their derivatives, products of which they are components (e.g., conjugates), and drug products containing synthetically produced polypeptides, polynucleotides, and oligosaccharides are within the scope of this guidance.


Click this LINK to know more about the safety assessment of potential elemental impurities, elemental classification and risk assessment and control of elemental impurities, etc.







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