October 4, 2021

Today the U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) is announcing an upcoming informational, pre-recorded webinar entitled “CVM Draft Guidance for Industry Documents #253 and 254: Good Manufacturing Practices and Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based Products (ACTPs).”

CVM recently issued two draft guidance documents that, if finalized, are intended to assist manufacturers by providing product-specific recommendations that will help developers of ACTPs meet FDA manufacturing requirements.

The first draft guidance, #253, “Good Manufacturing Practices for Animal Cells, Tissues, and Cell- and Tissue-Based Products” provides manufacturers of ACTPs with recommendations for meeting requirements for current good manufacturing practices. It addresses the methods, facilities and controls used for manufacturing ACTPs, including steps in recovery, processing, storage, labeling, packaging and distribution. 

The second draft guidance #254, “Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based Products”, if finalized, will assist sponsors, firms or establishments that participate in the manufacture of ACTPs or perform any aspect of the ACTP donor eligibility determination by providing CVM’s recommendations on screening, testing and selecting appropriate donors. 

The webinar will provide information and examples on current good manufacturing practices related to preserving cellular function and integrity, ensuring consistency of the process and product, preventing contamination and preventing transmission of disease.  

The webinar will be available for viewing on this webpage beginning October 20, 2021, and will remain on the website as a resource for ACTP developers.  

Stakeholders can submit questions by emailing [email protected]. 

CVM is also accepting public comments on both draft guidance documents until November 22, 2021, to ensure that we are able to consider comments before drafting final guidance documents; however, comments on guidance documents are welcome at any time. To electronically submit comments to the docket, please visit https://www.regulations.gov and type FDA-2021-D-0399 in the search box for draft guidance for industry #253 and FDA-2021-D-0401 for draft guidance for industry #254.  

For more information:

• Draft guidance, #253, “Good Manufacturing Practices for Animal Cells, Tissues, and Cell- and Tissue-Based Products 
• Draft guidance #254, “Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based Products” 
• FDA Issues Draft Guidance on Donor Eligibility and Manufacturing of Cellular Therapies for Animals