What is ICH Q3D and Why is it Necessary?

ICH Q3D Elemental Impurities is a quality guideline for the control of elemental impurities in new drug products and it establishes Permitted Daily Exposures (PDEs) for 24 Elemental Impurities (EIs) for drug products administered by the oral, parenteral and inhalation routes of administration.

Elemental impurities in drug products may arise from several sources; they may be residual catalysts that were added intentionally in synthesis or may be present as impurities (e.g., through interactions with processing equipment or container/closure systems or by being present in components of the drug product). Because elemental impurities do not provide any therapeutic benefit to the patient, their levels in the drug product should be controlled within acceptable limits.

 Q3D is the conclusion of several initiatives intended to modernize the control of elemental impurities in pharmaceutical products. The U.S. Pharmacopeia had been discussing the modernization of its heavy metals monograph for several years .The European Medicines Agency after many years of discussion was the first to implement a risk-based approach to control residual catalysts in pharmaceutical products approved to be marketed in the EU. Q3D guideline was developed to develop a globally harmonized guideline, based on efforts made by different pharmacopeias and regulatory authorities.

Q3D comprises safety-based permitted daily exposures for 24 elemental and recommendations for a risk-based and science-based approach to control of those elements in pharmaceutical products. Based on my recent interaction with quality consulting team from Source Consulting. Industries should be ready to take suitable action with reference to the Q3D requirements. For any question and concerns reach out to Source consulting.