21 C.F.R. § 1271.225 Process changes.
Title 21 - Food and Drugs
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.
Title 21: Food and Drugs
PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS
Subpart D—Current Good Tissue Practice
§ 1271.225 Process changes.
