[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1271.225]

[Page 734]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 1271_HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS
--Table of Contents
 
                 Subpart D_Current Good Tissue Practice
 
Sec. 1271.225  Process changes.

    Any change to a process must be verified or validated in accordance 
with Sec. 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.