21 CFR § 1271.225 Human Cells, Tissues, and Cellular and Tissue-Based Products

§ 1271.225 Process changes.

Current through Sep 8, 2026 · Read all of Part 1271

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.

← § 1271.220 Processing and process controls.§ 1271.230 Process validation. →