Any change to a process must be verified or validated in accordance with § 1271.230 , to ensure that the change does not create an adverse impact elsewhere in the operation, and must be approved before implementation by a responsible person with appropriate knowledge and background. You must communicate approved changes to the appropriate personnel in a timely manner.
21 CFR Part 1271 · Human Cells, Tissues, and Cellular and Tissue-Based Products
§ 1271.225 Process changes
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 § 1271.225
Form FDA 483 observations citing this section, fiscal years 2009–2025 (Human Tissue for Transplantation).
- Verification/validation 18
- Approval and timely communication 1
FDA guidance that cites § 1271.225
Amendment history
Federal Register documents that created or amended this section.
- 66 FR 5466 19 Jan 2001