21 C.F.R. § 1271.225
Process changes.
Cite as 21 C.F.R. § 1271.225 (2026)
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.
- Cross-references to the CFR
- 1271.230