[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR211.56]

[Page 143]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 211_CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS--Table of Contents
 
                   Subpart C_Buildings and Facilities
 
Sec.  211.56  Sanitation.

    (a) Any building used in the manufacture, processing, packing, or 
holding of a drug product shall be maintained in a clean and sanitary 
condition, Any such building shall be free of infestation by rodents, 
birds, insects, and other vermin (other than laboratory animals). Trash 
and organic waste matter shall be held and disposed of in a timely and 
sanitary manner.
    (b) There shall be written procedures assigning responsibility for 
sanitation and describing in sufficient detail the cleaning schedules, 
methods, equipment, and materials to be used in cleaning the buildings 
and facilities; such written procedures shall be followed.
    (c) There shall be written procedures for use of suitable 
rodenticides, insecticides, fungicides, fumigating agents, and cleaning 
and sanitizing agents. Such written procedures shall be designed to 
prevent the contamination of equipment, components, drug product 
containers, closures, packaging, labeling materials, or drug products 
and shall be followed. Rodenticides, insecticides, and fungicides shall 
not be used unless registered and used in accordance with the Federal 
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 135).
    (d) Sanitation procedures shall apply to work performed by 
contractors or temporary employees as well as work performed by full-
time employees during the ordinary course of operations.