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

Current through Register Vol. 50, No. 6, June 20, 2024
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.