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21 CFR Part 1271 · Human Cells, Tissues, and Cellular and Tissue-Based Products

§ 1271.230 Process validation

Subpart D - Current Good Tissue Practice Official text on eCFR Amendment history

(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.

Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.

What FDA inspectors cite under § 1271.230

Form FDA 483 observations citing this section, fiscal years 2009–2025 (Human Tissue for Transplantation).

  • Validation & approval--established procedures 47
  • Process validation procedures 36
  • Reduced risk representation 7
  • Changes to validated process 6
  • Documented, dated, signed 4
  • Change activities documented 1

Warning letters citing § 1271.230

6 FDA warning letters since 2017 cite this section :

FDA guidance that cites § 1271.230

Amendment history

Federal Register documents that created or amended this section.