NAC585.290. Buildings used in manufacturing drugs.

     1. A licensee shall maintain in a clean and orderly condition the buildings used in the manufacture of drugs. The buildings must be of suitable size, construction and location to facilitate adequate cleaning, maintenance and proper operations in the manufacturing, processing, packing, labeling and holding of a drug. Separate rooms may be required to prevent cross-contamination of products.

     2. A licensee shall provide buildings with adequate space for:

     (a) The orderly placement of equipment and materials to minimize the risk of mixups between different drugs, components of drugs, materials in process, packaging materials, or labeling and to minimize the possibility of contamination;

     (b) The receipt, storage and withholding from use of components, pending their sampling, identification and testing before release for manufacturing or packaging;

     (c) The holding of rejected components before disposition to preclude the possibility of their use in any manufacturing or packaging procedure for which they are unsuitable;

     (d) The storage of components, containers, packaging materials and labeling;

     (e) Any manufacturing and processing operations;

     (f) Any packaging or labeling operations;

     (g) The storage of finished products; and

     (h) The control of production and laboratory operations.

     [Comm’r of Food & Drugs, Amygdalin and Procaine Hydrochl. §§ 3.1-3.1.1.8, eff. 5-15-78]