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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2019.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2019]
[CITE: 21CFR226]


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.

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.

Sec. 226.30 Equipment.

Equipment used for the manufacture, processing, packaging, bulk shipment, labeling, holding, or control of Type A medicated article(s) or their components shall be maintained in a clean and orderly manner and shall be of suitable design, size, construction, and location to facilitate maintenance and operation for its intended purpose. The equipment shall:

(a) Be so constructed that any surfaces that come into contact with Type A medicated article(s) are suitable, in that they are not reactive, additive, or absorptive to an extent that significantly affects the identity, strength, quality, or purity of the Type A medicated article(s) or its components.

(b) Be so constructed that any substance required for the operation of the equipment, such as lubricants, coolants, etc., may be employed without hazard of becoming an unsafe additive to the Type A medicated article(s).

(c) Be constructed to facilitate adjustment, cleaning, and maintenance, and to assure uniformity of production and reliability of control procedures and to assure the exclusion from Type A medicated article(s) of contamination, including cross-contamination from manufacturing operations.

(d) Be suitably grounded electrically to prevent lack of uniform mixing due to electrically charged particles.

(e) Be of suitable size and accuracy for use in any intended measuring, mixing, or weighing operations.

Authority: 21 U.S.C. 351, 352, 360b, 371, 374.
Source: 40 FR 14031, Mar. 27, 1975, unless otherwise noted.