[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1271]

[Page 730]
 
                        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 
 
                 Subpart D_Current Good Tissue Practice
 
Sec.  1271.190  Facilities.

    (a) General. Any facility used in the manufacture of HCT/Ps must be 
of suitable size, construction, and location to prevent contamination of 
HCT/Ps with communicable disease agents and to ensure orderly handling 
of HCT/Ps without mix-ups. You must maintain the facility in a good 
state of repair. You must provide lighting, ventilation, plumbing, 
drainage, and access to sinks and toilets that are adequate to prevent 
the introduction, transmission, or spread of communicable disease.
    (b) Facility cleaning and sanitation. (1) You must maintain any 
facility used in the manufacture of HCT/Ps in a clean, sanitary, and 
orderly manner, to prevent the introduction, transmission, or spread of 
communicable disease.
    (2) You must dispose of sewage, trash, and other refuse in a timely, 
safe, and sanitary manner.
    (c) Operations. You must divide a facility used in the manufacture 
of HCT/Ps into separate or defined areas of adequate size for each 
operation that takes place in the facility, or you must establish and 
maintain other control systems to prevent improper labeling, mix-ups, 
contamination, cross-contamination, and accidental exposure of HCT/Ps to 
communicable disease agents.
    (d) Procedures and records. (1) You must establish and maintain 
procedures for facility cleaning and sanitation for the purpose of 
preventing the introduction, transmission, or spread of communicable 
disease. These procedures must assign responsibility for sanitation and 
must describe in sufficient detail the cleaning methods to be used and 
the schedule for cleaning the facility.
    (2) You must document, and maintain records of, all cleaning and 
sanitation activities performed to prevent contamination of HCT/Ps. You 
must retain such records 3 years after their creation.