Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications: Guidance for Industry

Issue Date: February 1, 2010
Issued by: Center for Biologics Evaluation and Research
Topic(s): Vaccines
Status: Final

Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications: Guidance for Industry

We, FDA, are providing you, manufacturers of viral vaccines, guidance for the characterization and qualification of cell substrates, viral seeds, and other biological materials used for the production of viral vaccines for human use. This guidance applies to the development of viral vaccines for the prevention and treatment of infectious diseases that are regulated by the Office of Vaccines Research and Review (OVRR) of the Center for Biologics Evaluation and Research (CBER) under section 351 of the Public Health Service (PHS) Act (42 U.S.C. 262).

Download the Guidance Document