Current Good Manufacturing Practice for Animal Cells, Tissues, and Cell- and Tissue-Based Products; Guidance for Industry; Availability

Issuing agencies

Abstract

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry #253 entitled "Current Good Manufacturing Practice for Animal Cells, Tissues, and Cell- and Tissue-Based Products." FDA's Center for Veterinary Medicine (CVM) is issuing this guidance to provide establishments that manufacture animal cells, tissues, and cell- and tissue-based products (ACTPs) with recommendations for meeting requirements for current good manufacturing practice (CGMP). All new animal drugs, including ACTPs, are required to be manufactured in accordance with CGMP to ensure that such drugs meet the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as to safety, and have the identity, strength, quality, and purity characteristics, which they purport to or are represented to possess. This guidance also provides FDA's recommendations for those aspects of manufacturing specific to ACTPs in accordance with existing CGMP regulations, as applicable, and with the FD&C Act. In this guidance, we specifically address the methods, facilities, and controls used for manufacturing ACTPs.