[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR111.20]

[Page 233-234]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 111_CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS--Table of Contents
 
                  Subpart C_Physical Plant and Grounds
 
Sec.  111.20  What design and construction requirements apply to your physical plant?

    Any physical plant you use in the manufacture, packaging, labeling, 
or holding of dietary supplements must:
    (a) Be suitable in size, construction, and design to facilitate 
maintenance, cleaning, and sanitizing operations;
    (b) Have adequate space for the orderly placement of equipment and 
holding of materials as is necessary for maintenance, cleaning, and 
sanitizing operations and to prevent contamination and mixups of 
components and dietary supplements during manufacturing, packaging, 
labeling, or holding;
    (c) Permit the use of proper precautions to reduce the potential for 
mixups or contamination of components, dietary supplements, or contact 
surfaces, with microorganisms, chemicals, filth, or other extraneous 
material. Your physical plant must have, and you must use, separate or 
defined areas of adequate size or other control systems, such as 
computerized inventory controls or automated systems of separation, to 
prevent contamination and mixups of components and dietary supplements 
during the following operations:
    (1) Receiving, identifying, holding, and withholding from use, 
components, dietary supplements, packaging, and labels that will be used 
in or during the manufacturing, packaging, labeling, or holding of 
dietary supplements;
    (2) Separating, as necessary, components, dietary supplements, 
packaging, and labels that are to be used in manufacturing from 
components, dietary supplements, packaging, or labels that are awaiting 
material review and disposition decision, reprocessing, or are awaiting 
disposal after rejection;
    (3) Separating the manufacturing, packaging, labeling, and holding 
of different product types including different types of dietary 
supplements and other foods, cosmetics, and pharmaceutical products;
    (4) Performing laboratory analyses and holding laboratory supplies 
and samples;
    (5) Cleaning and sanitizing contact surfaces;
    (6) Packaging and label operations; and
    (7) Holding components or dietary supplements.
    (d) Be designed and constructed in a manner that prevents 
contamination of components, dietary supplements, or contact surfaces.
    (1) The design and construction must include:
    (i) Floors, walls, and ceilings that can be adequately cleaned and 
kept clean and in good repair;
    (ii) Fixtures, ducts, and pipes that do not contaminate components, 
dietary supplements, or contact surfaces by dripping or other leakage, 
or condensate;
    (iii) Adequate ventilation or environmental control equipment such 
as airflow systems, including filters, fans, and other air-blowing 
equipment, that minimize odors and vapors (including steam and noxious 
fumes) in areas where they may contaminate components, dietary 
supplements, or contact surfaces;
    (iv) Equipment that controls temperature and humidity, when such 
equipment is necessary to ensure the quality of the dietary supplement; 
and
    (v) Aisles or working spaces between equipment and walls that are 
adequately unobstructed and of adequate width to permit all persons to 
perform their duties and to protect against contamination of components, 
dietary supplements, or contact surfaces with clothing or personal 
contact.
    (2) When fans and other air-blowing equipment are used, such fans 
and

[[Page 234]]

equipment must be located and operated in a manner that minimizes the 
potential for microorganisms and particulate matter to contaminate 
components, dietary supplements, or contact surfaces;
    (e) Provide adequate light in:
    (1) All areas where components or dietary supplements are examined, 
processed, or held;
    (2) All areas where contact surfaces are cleaned; and
    (3) Hand-washing areas, dressing and locker rooms, and bathrooms.
    (f) Use safety-type light bulbs, fixtures, skylights, or other glass 
or glass-like materials when the light bulbs, fixtures, skylights or 
other glass or glass-like materials are suspended over exposed 
components or dietary supplements in any step of preparation, unless 
your physical plant is otherwise constructed in a manner that will 
protect against contamination of components or dietary supplements in 
case of breakage of glass or glass-like materials.
    (g) Provide effective protection against contamination of components 
and dietary supplements in bulk fermentation vessels, by, for example:
    (1) Use of protective coverings;
    (2) Placement in areas where you can eliminate harborages for pests 
over and around the vessels;
    (3) Placement in areas where you can check regularly for pests, pest 
infestation, filth or any other extraneous materials; and
    (4) Use of skimming equipment.
    (h) Use adequate screening or other protection against pests, where 
necessary.