EMA: Draft Guideline on Elemental Impurities in Veterinary Medicines
The EMA has published for consultation the draft guideline on risk management requirements for elemental impurities in veterinary medicinal products (VMPs). As the Ph. Eur. General Monograph 2619 on pharmaceutical preparations applies to all VMPs, risk management of elemental impurities in all VMPs in the EU market is expected.
As the requirements of the Ph. Eur. also apply to immunological VMPs, there is a need to revise the reflection paper to transform it into a guideline and to include in the scope of this guideline non-immunological and immunological VMPs.
Clear guidance for appropriate risk assessment is considered crucial especially for immunological VMPs since, as elemental impurity testing is generally not foreseen in the context of manufacturing control and final product testing of immunological VMPs.
This new guideline will replace the Reflection paper on risk management requirements for elemental impurities in veterinary medicinal products (EMA/CVMP/QWP/153641/2018) and the Implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products (EMA/CVMP/QWP/631010/2017-Rev.2).
The deadline for comments is 31 January 2025.
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