La. Admin. Code tit. 51 § VI-1517

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

Section VI-1517 - Equipment [formerly paragraph 6:199]

A. Equipment used for the manufacture, processing, packing, labeling, holding, testing or control of drugs shall be maintained in a clean and orderly manner and shall be of suitable design, size, construction and location to facilitate cleaning, maintenance and operation of its intended purpose. The equipment shall:

1. [formerly paragraph 6:199-1] be constructed so that all surfaces that come into contact with a drug product shall not be reactive, additive or absorptive so as to alter the safety, identity strength, quality or purity of the drug or its components beyond established requirements;

2. [formerly paragraph 6:199-2] be constructed so that any substance required for operation of the equipment, such as lubricant or coolants, do not contact drug products so as to alter the safety, identity, strength, quality or purity of the drug or its components beyond the established requirements;

3. [formerly paragraph 6:199-3] be constructed and installed to facilitate adjustment, disassembly, cleaning and maintenance to assure the reliability of control procedure's uniformity of production and exclusion from the drugs of contamination from previous and current operations that might affect the safety, identity, strength, quality or purity of the drug or its components beyond established requirements;

4. [formerly paragraph 6:199-4] be of suitable type, size and accuracy for any testing, measuring, mixing, weighing or other processing of storage operations. The regulations in this Part permit the use of precision automatic, mechanical or electronic equipment in the production and control of drugs when inspection and checking procedures are used to assure proper performance.

La. Admin. Code tit. 51, § VI-1517

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

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