Regulatory Updates In Brief
This article was originally published in The Gold Sheet
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.
You may also be interested in...
The US FDA revised two drug good manufacturing practice inspection programs in its compliance manual to reflect certain ICH guidance documents, efforts to control nitrosamine impurities and the use of inspection alternatives for evaluating facilities. Plus more recent developments in GMP and CMC compliance.
Site-based metrics praised; lot acceptance rates, invalidated OOS rates discouraged. Agency official admits some proposed metrics were “not the best.”
Questions about contamination control strategy raised as European Medicines Agency makes EU GMP Annex I revision a top priority in its 2021 work plan.