The approach to extraneous agent testing in immunological veterinary medicinal products (IVMPs) has recently been updated and manufacturers of these products are required to comply with it from 1 July 2020.
With the new and more flexible approach, methods are no longer described in detail and users can tailor the tests to individual product needs. From starting material to finished product, users will have to follow an overall risk-management approach to ensure that the best testing strategies are selected to provide a consistent manufacturing process and thus ensure the quality of the product.
This new approach will also enable the use of state-of-the-art testing methods and is expected to increase the development of more robust in vitro methods and reduce the use of in vivo testing.
To help users put the new approach into practice, the EDQM is organising a symposium entitled “Management of Extraneous Agents in Immunological Veterinary Medicinal Products (IVMPs)”, on 1 and 2 April 2020 in Strasbourg, France.
This event is an opportunity to present and discuss concrete case studies. It will also allow participants to get a better understanding of future developments and expectations for extraneous agent testing.
More information on the programme and how to register will be available soon.