[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: 21CFR1271.180]

[Page 732]
 
                        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. 1271.180  Procedures.

    (a) General. You must establish and maintain procedures appropriate 
to meet core CGTP requirements for all steps that you perform in the 
manufacture of HCT/Ps. You must design these procedures to prevent 
circumstances that increase the risk of the introduction, transmission, 
or spread of communicable diseases through the use of HCT/Ps.
    (b) Review and approval. Before implementation, a responsible person 
must review and approve these procedures.
    (c) Availability. These procedures must be readily available to the 
personnel in the area where the operations to which they relate are 
performed, or in a nearby area if such availability is impractical.
    (d) Standard procedures. If you adopt current standard procedures 
from another organization, you must verify that the procedures meet the 
requirements of this part and are appropriate for your operations.