La. Admin. Code tit. 51 § VI-1519

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

Section VI-1519 - Product Production and Quality Control [formerly paragraph 6:200]

A. Production and control procedures shall include all reasonable precautions including the following to assure that the drugs produced have the safety, identity, quality, strength and purity they purport to possess:

1. [formerly paragraph 6:201-1] each significant step in the process, such as selection, weighing and measuring during the various stages of the processing and determination of the finished yield shall be performed by a competent and responsible individual and checked by a second competent and responsible individual; or if such steps in the processing are controlled by precision automatic, mechanical or electronic equipment, their performance is checked. The written record of the significant steps in the process shall be performed by a person having requisite abilities; such identifications shall be recorded immediately following the completion of such steps;

2. [formerly paragraph 6:201-2] all containers, lines and equipment used during the production of a batch of drugs shall be properly identified at all times to accurately and completely indicate their contents, and when necessary, the stage of processing of the batch;

3. [formerly paragraph 6:201-3] to minimize contamination and prevent mix-ups, equipment, utensils and containers shall be thoroughly cleaned or sanitized and stored and have previous batch identification removed or obliterated between batches at intervals while production operations are continuing;

4. [formerly paragraph 6:201-4] precautions shall be taken to minimize microbiological and other contamination in the production of drugs purporting to be sterile, or which by virtue of their intended use should be free from objectionable microorganisms, such as the known common pathogens and others which might affect stability, color or taste;

5. [formerly paragraph 6:201-5] procedures shall be established to minimize the hazard to any drugs while being manufactured or stored. Such procedures shall meet with the approval of the state health officer;

6. [formerly paragraph 6:201-6] to assure the uniformity and integrity of products, there shall be in-process controls, such as checking the weights and disintegration times of tablets, the adequacy of mixing, the homogeneity of suspensions and the clarity of solutions. In-process sampling shall be done at intervals;

7. [formerly paragraph 6:201-7] representative samples of all dosage form drugs shall be tested to determine their conformance with the specifications of the product before distribution;

8. [formerly paragraph 6:201-8] review and approval of all production and control records, including packing and labeling, shall be made prior to the release for distribution of a batch, and records maintained to show this review. A thorough investigation of the failure of a batch to meet any of its specifications shall be undertaken whether or not the batch has been distributed. The investigation shall extend to other batches of the same drug and other drugs that may have been associated with a problem found with that batch. A written record of the investigation shall be made and shall include the conclusion and follow-up;

9. [formerly paragraph 6:201-9] returned goods shall be identified as such and held. If the conditions under which returned goods have been held, stored or shipped prior to or during their return, or the condition of the product, its container, carton or labeling as a result of storage or shipping cast doubt on the safety, identity, strength, quality or purity of the drug, the returned goods shall be destroyed or subjected to examination or testing to assure the material meets all original standards or specifications before being returned to stock for warehouse distribution or repacking. If the product is neither destroyed nor returned to store, it may be reprocessed provided the final product meets all of its standards and specifications. Records of returned goods shall be maintained and shall indicate the quantity returned, date and actual disposition of the product. If the reason for returned goods implicates associated batches, an appropriate investigation shall be made in accordance with the requirements of §1519. A.8 of this Part;

10. [formerly paragraph 6:201-10] use of asbestos-containing or other fiber releasing filters:

a. [formerly paragraph 6:201-10 (1)] filter used in the manufacture, process or packing of components of drug products for parenteral injections in humans shall not release fibers into such products. No asbestos-containing or other fiber-releasing filter may be used in the manufacture, process or packaging of such products unless it is not possible to manufacture that drug product or component without the use of such a filter. Filtration, as needed shall be through a non-fiber-releasing filter. This filter shall be defined as a non-asbestos filter that after the pretreatment such as washing or flushing, will not continue to release fibers into the drug product or component that is being filtered. A fiber is defined as any particle with length at least three times greater than its width;

b. [formerly paragraph 6:201-10 (2)] if the use of a fiber-releasing filter is required, an additional non-fiber releasing filter or maximum pore size of 0.22 microns (0.45 microns if the manufacturing conditions so dictate) shall subsequently be used to reduce the content of any asbestos-form particle in the drug product or component.

La. Admin. Code tit. 51, § VI-1519

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.