---
kind: "section"
citation: "21 C.F.R. § 1271.225"
title: "21"
number: "1271.225"
heading: "Process changes."
url: "https://uscodex.org/cfr/21/1271.225"
---

# §1271.225. Process changes.


Any change to a process must be verified or validated in accordance with [§ 1271.230](/cfr/21/1271.230.md), 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.


## Notes

### Source

Source: 69 FR 68681, Nov. 24, 2004, unless otherwise noted.

### Authority

Authority: 42 U.S.C. 216, 243, 263a, 264, 271.

### Source

Source: 66 FR 5466, Jan. 19, 2001, unless otherwise noted.