cGMPs / QRM Process

FDA Releases Final Guidance on Characterization of Cell Substrates and Bio Materials for Viral Vaccines

Source: PharmaManufacturing.com

Mar 03, 2010

FDA has released finalized, nonbinding guidance on the characterization and qualification of cell substrates and biologicial materials used in the production of viral vaccines.

A critical section for manufacturers regards testing at different stages of production, from cell banks and pre-production cells to final filled product. The guidance also contains descriptions of test methods for adventitious agents and cell properties.

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