FDA panel mulls cGMP issues
Food and Drug Administration is convening the inaugural meeting of
its Advisory Committee for Pharmaceutical Science's Manufacturing
Subcommittee.
As this edition of In-pharmatechnologist.com goes online, the US Food and Drug Administration is convening the inaugural meeting of its Advisory Committee for Pharmaceutical Science's Manufacturing Subcommittee.
The new panel is charged with examining ways of ensuring the quality of pharmaceutical manufacturing in both the product review and inspection (Good Manufacturing Practice) processes.
In particular, the Subcommittee will serve as a forum for vetting a number of issues raised under the FDA's GMP initiative, launched two years ago by Health and Human Services Secretary Tommy G. Thompson.
It will also discuss a concept paper, published last year in the Federal Register, covering sterile drug products produced by aseptic processing.
