Louisiana Administrative Code
Title 51 - PUBLIC HEALTH-SANITARY CODE
Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics
Chapter 15 - Current Good Manufacturing Practices in the Manufacture of Drugs
Section VI-1517 - Equipment [formerly paragraph 6:199]
Universal Citation: LA Admin Code VI-1517
Current through Register Vol. 50, No. 9, September 20, 2024
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.
AUTHORITY NOTE: Promulgated in accordance with the provisions of R.S. 40:4(A)(1)(a). Also see R.S. 40:601 et seq.
Disclaimer: These regulations may not be the most recent version. Louisiana may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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