ABSTRACT

In 1969, the US Food and Drug Administration (FDA) promulgated its first current good manufacturing practice (CGMP) regulation for the manufacturing, processing, packing, or holding of human food. This regulation has often been referred to as the umbrella CGMP because it applies to the entire food industry. The FDA has also promulgated CGMPs for frozen raw breaded shrimp, smoked and smoke-flavored fish, thermally processed low-acid canned foods, acidified foods, bottled drinking water, and cacao products and confectionery. The FDA considered for a period of time issuing separate CGMP regulations to cover requirements for each major segment of the food industry. To gather information and opinions on the impact of the proposed revision, FDA also held hearings in Chicago, San Francisco, and in Atlanta. The purpose of proposing coding and recordkeeping was to facilitate a manufacturer's recall of suspect products in case such a recall was recommended by the FDA.