La. Admin. Code tit. 51 § VI-1515

Current through Register Vol. 50, No. 11, November 20, 2024

Section VI-1515 - Building Requirements [formerly paragraph 6:198-1]

A. [formerly paragraph 6:198-1] Buildings shall provide space for:

1. [formerly paragraph 6:198-1 (1)] orderly placement of equipment and materials to minimize the possibility of contamination;

2. [formerly paragraph 6:198-1 (2)] the receipt, storage and withholding from use of components pending sampling, identification and testing prior to release by the materials approval unit for manufacturing or packaging;

3. [formerly paragraph 6:198-1 (3)] the holding of rejected components prior to distribution to preclude the possibility of their use in manufacturing or packaging procedures for which they are unsuitable;

4. [formerly paragraph 6:198-1 (4)] the storage of components, containers, packing materials and labeling;

5. [formerly paragraph 6:198-1 (5)] any manufacturing and processing operation performed;

6. [formerly paragraph 6:198-1 (6)] any packing or labeling operation;

7. [formerly paragraph 6:198-1 (7)] storage of finished product;

8. [formerly paragraph 6:198-1 (8)] control and production laboratory operations.

B. [formerly paragraph 6:198-2] Provide lighting and ventilation as per §313. A.3 of this Part, and screening, and when necessary for the intended production or control purposes (for example, the production of sterile products or to prevent antibiotic pollution) provide facilities for positive air pressure, microbiological, dust and temperature controls to:

1. [formerly paragraph 6:198-2 (1)] minimize contamination of products by extraneous adulterants, including cross contamination of one product with dust particles of ingredients arising from the manufacture, storage or handling of another product;

2. [formerly paragraph 6:198-2 (2)] provide for storage of drug components, in-process materials, and finished drugs in conformance with stability information as derived under §1705. A and B of this Code;

3. [formerly paragraph 6:198-2 (3)] minimize dissemination of microorganisms from one area to another;

4. [formerly paragraph 6:198-2 (4)] provide locker facilities for employee clothing and belongings. Provide washing facilities equipped with hot and cold water under pressure, delivered through a mixing faucet. Soap and sanitary towels or air dryer shall be provided at each lavatory.

C. [formerly paragraph 6:198-3 ] Provide a supply of potable water [LAC 51:XII (Water Supplies)] under conditions of positive pressure in a plumbing system designed in accord with the LSPC and free of defects that could cause or contribute to contamination of any drug. Drains shall be a minimum of 4 inches, and where connected directly to a sewer, shall be equipped with properly vented fixture traps to prevent sewer gas entry into any occupied space.

D. [formerly paragraph 6:198-4] Provide suitable housing and space for the care of all laboratory animals.

E. [formerly paragraph 6:198-5] Provide for safe and sanitary disposal of sewage, trash and other refuse within and from the building and immediate premises.

La. Admin. Code tit. 51, § VI-1515

Promulgated by the Department of Health and Hospitals, Office of Public Health, LR 28:1252 (June 2002), amended LR 38:2792 (November 2012).

AUTHORITY NOTE: Promulgated in accordance with provisions of R.S. 40:4(A)(1)(a). Also see 40:601 et seq.