Validation is required for tests used in lot release of vaccines. Validation parameters differ depending on the nature of the test and its application. The goal of this project is to develop suitable strategies for validating tests that can be applied to assays under development in the product laboratories and divisions in OVRR as well as to tests that must be established in the Quality Control Unit in DVP. A useful outcome of this project is the practical application of validation strategies to the development of new tests at FDA and in collaboration with other regulatory agencies and industry. Another outcome is the formulation of the principles of assay validation suitable for regulatory reviewers assigned to biological product license applications and supplements. A third outcome is the incorporation of appropriate validation procedures in primary research activities of CBER scientists. All three of these outcomes have been achieved, and additional development and application of this project are continuing.
