Code of Federal Regulations · Section

§ 1271.225 — Process Changes

21 C.F.R. § 1271.225

View:

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.

Authorizing Statute