La. Admin. Code tit. 51 § VI-1521

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

Section VI-1521 - Components [formerly paragraph 6:202]

A. All components and other materials used in the manufacture, processing and packing of drug products, and materials necessary for building and equipment maintenance, shall upon receipt be stored and handled in a safe, sanitary and orderly manner to assure safety, purity and strength. Precautions shall be taken to prevent mix-ups and cross-contamination affecting drugs and drug products. Components shall be held from use until they have been identified, sampled and tested for conformance to established specifications and are released by a material approval unit. Controls of components shall include the following.

1. [formerly paragraph 6:202-1] Each container of component shall be examined visually for damage or contamination prior to use, including examination for breakage of seals, when indicated.

2. [formerly paragraph 6:202-2 ] Samples shall be taken from component containers from each lot and shall be subjected to one or more tests to establish their specific identity.

3. [formerly paragraph 6:202-3] Samples of components liable to contamination with filth, insect infestation or other extraneous contaminants shall be appropriately examined.

4. [formerly paragraph 6:202-4] Samples of components liable to microbiological contamination shall be subjected to microbiological test prior to use. Such components shall not contain microorganisms that are objectionable in view of their intended use.

5. [formerly paragraph 6:202-5] Samples of all components intended for use as active ingredients shall be tested to determine their strength in order to assure conformance with specifications approved by the state health officer.

6. [formerly paragraph 6:202-6] Components which have previously been approved shall be identified and retested as necessary to assure that they continue to meet specifications:

a. [formerly paragraph 6:202-6 (1)] Components which have been approved shall be handled and stored to guard against contamination or being contaminated by other drugs or components.

b. [formerly paragraph 6:202-6 (2)] Components which have been approved shall be rotated in such a manner that the oldest stock is used first.

c. [formerly paragraph 6:202-6 (3)] Rejected components shall be identified and held to preclude their use in manufacturing or processing procedures for which they are unsuitable.

7. [formerly paragraph 6:202-7] Records shall be maintained for at least two years after distribution has been completed, or one year after the drug's expiration date, whichever is longer. Such records shall include:

a. [formerly paragraph 6:202-7 (1)] the identity and quantity of the component, the name of the supplier, the supplier's lot number and the date of receipt;

b. [formerly paragraph 6:202-7 (2)] examinations and tests performed, and rejected components and their disposition;

c. [formerly paragraph 6:202-7 (3)] an individual inventory and record for each component used in each batch of drug manufactured or processed.

8. [formerly paragraph 6:202-8] An identified reserve sample of all active ingredients consisting of at least twice the quantity necessary for all required tests, except those for sterility and determination of pyrogens, shall be retained for at least two years after distribution of the last drug lot incorporating the component has been completed, or one year after the expiration date of this last drug lot, whichever is longer.

La. Admin. Code tit. 51, § VI-1521

Promulgated by the Department of Health and Hospitals, Office of Public Health, LR 28:1253 (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.