FDA publishes finalized Guidance for Characterization and Qualification of Cell Substrates and Other Biological Materials

In February 2010, the FDA published the Guidance for Industry "Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications".

The document should provide 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. The 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).

This guidance is the finalization of the draft guidance entitled “Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases,” dated September 2006 (71 FR 57547). Furthermore, the guidance replaces the information pertaining to viral vaccines for the prevention and treatment of infectious diseases  provided in  “Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals,” from1993.  The recommendations on the production of viral vaccines for the prevention and treatment of infectious diseases, provided in International Conference on Harmonization (ICH) documents Q5A and Q5D will be supplemented by this guidance.  

The scope of this guidance document is limited to cell substrates of human or animal  origin. The GUIDANCE does not cover characterization of unicellular organisms, such as bacteria or yeast.  For the production of biological products not covered under this guidance,  “Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals,” dated 1993 (Ref. 1) is still the referred document.

More details can be found here.

The ECA Education Course "GMP for Vaccine Manufacturers" in Heidelberg, Germany from 13-15 October 2010 will provide you with an insight in all GMP relevant aspects of vaccine manufacturing as well as regulatory requirements

Author:
Axel H Schroeder
On behalf of the European Compliance Academy (ECA)

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