ABSTRACT
Good manufacturing practice regulations (also referred to as GMP, GMPs, current GMPs, cGMPs) were first proposed by the United States government in 1963, following congressional passage of the Kefauver-Harris amendment in 1962, in turn, following the thalidomide tragedy in the United Kingdom in 1960-1961. These regulations described the basic requirements for the manufacturing and packaging and distribution of finished pharmaceutical products.
