Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in Producing Viral Vaccines

Overview:

The U.S. Food and Drug Administration (FDA) on Sept. 28, 2006 issued new guidance to aid manufacturers in developing safe and effective cell-based viral vaccines. The updated guidance conveys information for determining the suitability of a cell culture for manufacturing, as well as testing and validating the safety and purity of the cells used in the development and production of viral vaccines.