In Brief: GMP final rule
This article was originally published in The Tan Sheet
Executive Summary
GMP final rule: FDA publishes final rule on five amendments to the good manufacturing practices regulations in the Jan. 20 Federal Register. The amendments, reflecting the agency's "retrospective review" of the cGMPs begun in 1982, are essentially unchanged from those contained in the 1991 proposed rule. The changes give manufacturers increased discretion over: separating production and storage areas; checking input/output from computer systems; expiration dating of IND products; examining reserve samples; and conducting annual batch reviews...