Legacy drugs do not need to be revalidated for the sake of complying with the “lifecycle approach” in FDA’s process validation guidance.
Regulatory Updates In Brief
ISPE discussion paper addresses revalidating legacy products; PDA tackles data integrity; FDA clarifies criteria for comparability protocols; FDA spells out criteria for developing assays for evaluating immunogenicity of therapeutic proteins; FDA sets new policy on grouping supplement; EMA outlines new expectations for sterility testing.