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EDQM clarifies elemental impurities guidelines for veterinary and other products.
The European Directorate for the Quality of Medicines & Healthcare (EDQM) has issued a clarification of guidelines for testing of elemental impurities for products that fall outside of the scope of the International Conference on Harmonization (ICH) Q3D guideline for elemental impurities.
ICH Q3D applies to most drug products for human use, but not for products for veterinary use.
As part of its implementation of ICH Q3D, the European Pharmacopoeia (Ph. Eur.) Commission proposed for deletion the cross reference to wet chemical testing for heavy metals (2.4.8) from all monographs on substances for human use only and for human and veterinary use, but not from monographs on substances for veterinary use only; the chapter Heavy Metals (2.4.8) would be kept in the Ph. Eur.
In addition, the commission decided to reproduce verbatim the ICH Q3D guideline in the Ph. Eur. chapter 5.20. This decision also concerns the scope of the guideline, and a cross reference to chapter 5.20 in the general monograph Pharmaceutical Preparations (2619) would be made so that the scope within the Ph. Eur. is equivalent to that of the guideline itself.
The clarification emphasizes that for products outside the scope of the ICH Q3D guideline such as products for veterinary use, the “absence of elemental impurities (incl. heavy metals) tests from an individual monograph on a substance used for their production does not release manufacturers from the need to control the level of such elements in their products, where relevant.”
As per the clarification, manufacturers are responsible to assess and control such impurities in a drug product using the principles of risk management defined in the ICH Q9 guideline or in the ICH Q3D guideline. Methods provided in the Ph. Eur. (such as the chapters 2.4.8., 2.4.20) could be used for the control of elemental impurities, but the suitability of the testing procedures will have to be demonstrated by the manufacturer.
The control strategy and demonstration of suitability will be part of the marketing authorization application dossier and the assessment of these data part of the marketing authorization procedure, according to the clarification statement.