Code of Federal Regulations (Last Updated: July 5, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter L - Regulations Under Certain Other Acts Administered by the Food and Drug Administration |
Part 1271 - Human Cells, Tissues, and Cellular and Tissue-Based Products |
Subpart D - Current Good Tissue Practice |
§ 1271.225 - Process changes.
Latest version.
-
§ 1271.225 Process changes.
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.