EMA releases guidance on elemental impurities in medicines

Published: 16-Feb-2015
Regulatory

Includes advice on safety assessments for potential elemental impurities


The European Medicines Agency (EMA) has issued guidance to advise pharmaceutical companies on how to manage elemental impurities in medicines already on the market.

The guideline applies to new finished drug products containing purified proteins and polypeptides (including proteins and polypeptides produced from recombinant or non-recombinant origins), their derivatives, and component products, such as conjugates. Also covered are drug products containing synthetically produced polypeptides, polynucleotides, and oligosaccharides. Advanced therapy medicines are not included. While the advice is not designed to help clinical research, it is designed to help in 'evaluating elemental impurities that may be present in a new drug,' the EMA said.

The guidance includes advice on safety assessments for potential elemental impurities; element classification; the control of elemental impurities; converting between permitted daily exposure (PDE) and concentration limits; analytical procedures; and lifecycle management. It explains that elemental impurities may arise from residual catalysts added in synthesis; contamination from processing equipment and container/closure systems; or by being present in components of a medicine. 'Because elemental impurities do not provide any therapeutic benefit to the patient, their levels in the drug product should be controlled within acceptable limits,' the guidance says.

The advice is based on work developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

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