Process changes.

1. Law
2. CFR 21
3. Food and Drugs
4. Food and Drug Administration, Department of Health and Human Services
5. Regulations Under Certain Other Acts Administered by the Food and Drug Administration
6. Human Cells, Tissues, and Cellular and Tissue-Based Products
7. Current Good Tissue Practice
8. Process changes.

§ 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.

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