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 the revised text 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.
Who should attend?
This training will be of interest to vaccine manufacturers, representatives from national and international regulatory bodies, and staff members and scientists involved in the quality control and, in particular, the extraneous agent testing of IVMPs, be it in R&D, manufacturing, regulatory affairs, quality assurance or similar functions in both industry and regulatory authorities, or sub-contracting laboratories.