guidelines ensuring the quality and purity of chemical products that are intended for use in pharmaceutical applications, and controls ensuring that methods and facilities used for production, processing, packaging, and storage result in drugs with consistent and sufficient quality, purity, and activity.
Good Manufacturing Practice is a set of regulations, codes, and guidelines for the manufacture of drug substances (also known as active pharmaceutical ingredients (APIs)) and drug products (known as medicinal products in Europe), medical devices, in vivo and in vitro diagnostic products, and foods. In the United States GMPs are referred to as "cGMPs" or "current Good Manufacturing Practices" GMP is a term that is recognised worldwide for the control and management of manufacturing and quality control testing of pharmaceutical products.