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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: 21CFR226.20]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER C--DRUGS: GENERAL

PART 226 -- CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES

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.

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