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Ph. Eur.: new approach to extraneous agents testing of IVMPs

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European Pharmacopoeia
Monograph
News
23 October 2019
Strasbourg, France

The European Pharmacopoeia Commission adopted 43 texts related to its new approach to extraneous agents testing of immunological veterinary medicinal products (IVMPs). From starting material to final product, users will now have to follow an overall risk-management approach to ensure they apply the best testing strategies in the context of a consistent manufacturing process.

This is a move from a prescriptive to a more flexible approach, which is scientifically sound and targeted, and allows for the use of fit-for-purpose methods. This new approach to extraneous agents testing in IVMPs is expected to enable the use of state-of-the-art methods, with a preference for in vitro over less robust in vivo methods. The revision will lead to additional deletion of animal tests, such as serological tests for identification of vaccine antigen or detection of extraneous agents in certain specific inactivated vaccines, previously performed on each batch of product.

In advance of the implementation of these 43 texts on 1 July 2020 and in order to help users prepare for the forthcoming changes, the EDQM will organise a symposium on IVMPs in April 2020 in Strasbourg.

More detail is available in the press release: New approach to extraneous agents testing of immunological veterinary medicinal products (IVMPs)

More information on the IVMP symposium.

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