Last call for elemental impurities risk assessments


Risk assessment of elemental impurities became mandatory for new marketing authorisation applications of human drug products in June 2016 and for human drug products already in the market in December 2017, when the ICH Q3D guideline was implemented. The revised European Pharmacopoeia General Monograph Pharmaceutical preparations (2619), which came into effect in January 2018, requires that manufacturers control the elemental impurities of pharmaceutical products by using a risk management approach.

However, the approach based on permitted daily exposure (PDE) presented in ICH Q3D and the European Pharmacopoeia General Chapter 5.20 cannot be easily applied to veterinary medicinal products and consequently, veterinary medicinal products have so far been outside the scope of the guideline and the European Pharmacopoeia General Chapter, but this is about to change in the next few years.

Now the CVMP has adopted a phased-in implementation approach as regards the implementation of the monograph to existing veterinary products in order to allow time for regulators to elaborate the guidance on the appropriate approach for risk assessment. The phased implementation approach applies to all veterinary medicinal products, with the exception of veterinary herbal products, radiopharmaceuticals and immunological products.

What is expected of you as an MAH of veterinary medicinal products and when?

The risk assessment of elemental impurities has to demonstrate that the veterinary medicinal product complies with the European Pharmacopoeia General Monograph (2619). In the risk assessment, known and potential elemental impurities and their sources are identified and evaluated, quantity of each detected or estimated impurity is evaluated and compared with the established PDE, and the risk assessment is then summarised and documented. The summary document includes the identification of the elemental impurities, their sources, comparison of the quantity of each detected or estimated impurity to the established permitted daily exposure (PDE) limits, and the evaluation of controls and acceptance criteria. However, this does not necessarily lead to routine testing of elemental impurities from veterinary medicinal products, as compliance can be demonstrated with a risk-based approach and by supply-chain control.

Risk assessments do not need to be submitted via variations, and the current control strategies are considered acceptable until a risk assessment is required. Please note, that the expected timetable for risk assessments depends on the status of the marketing authorisation of your product. By 2023, a full risk assessment should be available for all products for veterinary use that will be on the European Union market.

If you have any questions or if you need support for the risk assessment of elemental impurities, Medfiles is happy to help. Please don’t hesitate to contact us for more information!

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