EMA: New Guideline on Elemental Impurities in Veterinary Medicinal Products
The EMA has published the new Guideline on risk management requirements for elemental impurities in veterinary medicinal products (EMA/CVMP/426245/2023). It was developed to consolidate the existing documents on risk assessment and the management of elemental impurities in veterinary medicinal products into a single, clearly structured guideline. It replaces two earlier documents:
- the Reflection paper on risk management requirements for elemental impurities in veterinary medicinal products (2018)
- and the Implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products (Revision 2, 2020)
Commission Delegated Regulation (EU) 2021/805 amending Regulation (EU) 2019/6 on veterinary medicinal products clarifies that all monographs of the European Pharmacopoeia are generally applicable, including those for immunological veterinary medicinal products. General Monograph 2619 requires manufacturers to assess and control elemental impurities using a risk-based approach.
The new EMA guideline explains how these requirements are to be implemented for veterinary medicinal products and specifies the data expected in the product dossier. A complementary document (EMA/CVMP/426245/2023) outlines the phased submission of risk assessments for immunological veterinary medicinal products.
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