[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR226.20]

[Page 146-147]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 226--CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES--Table of Contents
 
   Subpart B--Construction and Maintenance of Facilities and Equipment
 
Sec. 226.20  Buildings.


    Buildings in which Type A medicated article(s) are manufactured, 
processed, packaged, labeled, or held shall be maintained in a clear and 
orderly manner and shall be of suitable size, construction and location 
in relation to surroundings to facilitate maintenance and operation for 
their intended purpose. The building shall:
    (a) Provide adequate space for the orderly placement of equipment 
and materials used in any of the following operations for which they are 
employed to minimize risk of mixups between different Type A medicated 
article(s), their components, packaging, or labeling:
    (1) The receipt, sampling, control, and storage of components.
    (2) Manufacturing and processing operations performed on the Type A 
medicated article(s).
    (3) Packaging and labeling operations.
    (4) Storage of containers, packaging materials, labeling, and 
finished products.
    (5) Control laboratory operations.
    (b) Provide adequate lighting and ventilation, and when necessary 
for the intended production or control purposes, adequate screening, 
dust and temperature controls, to avoid contamination of Type A 
medicated article(s), and to avoid other conditions unfavorable to the 
safety, identity, strength, quality, and purity of the raw materials and 
Type A medicated article(s) before, during, and after production.
    (c) Provide for adequate washing, cleaning, toilet, and locker 
facilities.

[[Page 147]]


Work areas and equipment used for the production of Type A medicated 
article(s) or for the storage of the components of Type A medicated 
article(s) shall not be used for the production, mixing or storage of 
finished or unfinished insecticides, fungicides, rodenticides, or other 
pesticides or their components unless such materials are recognized as 
approved drugs intended for use in animal feeds.