21 CFR 1271.230: Process validation
Requires HCT/P establishments to validate, document, and approve by date and signature any process whose results can't be fully verified, base disease-risk-reduction claims on verified or validated processes, and revalidate after changes.
Part 1271, Human Cells, Tissues, and Cellular and Tissue-Based Products · Subpart D, Current Good Tissue Practice
Recent 483s citing 1271.230
- Americord Registry LLC · Somerset, New JerseyProcesses with results which could not be fully verified by inspection and tests,… Nov 17, 2025
- AVEM Labs LLC · —Processes with results which could not be fully verified by inspection and tests,… May 21, 2025
- RTI Biologics, Inc. · Alachua, FloridaProcesses whose results could not be fully verified by inspection and tests, were… Jul 11, 2012
- Musculoskeletal Transplant Foundation · Edison, New JerseyWritten representation that processing methods reduce the risk of transmission of… Mar 13, 2009
The regulation text
§ 1271.230 Process validation.
(a)General. Where the results of processing described in § 1271.220 cannot be fully verified by subsequent inspection and tests, you must validate and approve the process according to established procedures. The validation activities and results must be documented, including the date and signature of the individual(s) approving the validation.
(b)Written representation. Any written representation that your processing methods reduce the risk of transmission of communicable disease by an HCT/P, including but not limited to, a representation of sterility or pathogen inactivation of an HCT/P, must be based on a fully verified or validated process.
(c)Changes. When changes to a validated process subject to paragraph (a) of this section occur, you must review and evaluate the process and perform revalidation where appropriate. You must document these activities.
Questions
What does 21 CFR 1271.230 require?
Requires HCT/P establishments to validate, document, and approve by date and signature any process whose results can't be fully verified, base disease-risk-reduction claims on verified or validated processes, and revalidate after changes.
Which sections are cited alongside 1271.230?
In the same 483s, investigators most often also cite 1271.195 (Environmental control and monitoring), 1271.160 (Establishment and maintenance of a quality program), 1271.250 (Labeling controls), 1271.270 (Records).