This guidance provides establishments that manufacture animal cells, tissues, and cell- and tissue-based products meeting the definition of a new animal drug (ACTPs) with recommendations for meeting current good manufacturing practices (CGMPs) requirements.  All new animal drugs, including ACTPs, must be manufactured in accordance with CGMPs 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.

There are both statutory and regulatory requirements for CGMPs.  The CGMP statutory requirements are found in section 501(a)(2)(B) of the FD&C Act.  The CGMP regulatory requirements are found in Title 21 of the Code of Federal Regulations, parts 210 and 211 (21 CFR parts 210 and 211). 

FDA recognizes that the manufacture of ACTPs presents unique considerations for complying with regulatory CGMPs and that these CGMP regulations do not specifically or fully address all aspects of the manufacture of ACTPs, including early stages of the ACTP manufacturing process.  This document is specific to ACTPs to help establishments that manufacture ACTPs meet statutory and applicable regulatory CGMPs.  New animal drugs not manufactured in conformity with statutory and regulatory CGMPs are adulterated under the relevant provisions of the FD&C Act.

In this guidance, we address the methods, facilities, and controls used for manufacturing ACTPs, including steps in recovery, processing, storage, labeling, packaging, and distribution.   
 

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