Kan. Admin. Regs. § 28-21-255

Current through Register Vol. 43, No. 46, November 14, 2024

Section 28-21-255 - Production and control procedures

(a) Production and control procedures shall include all reasonable precautions, including the following, to assure that the amygdalin (laetrile) produced has the safety, identity, strength, quality, and purity it purports to possess:

(1) Each significant step in the process, such as the selection, weighing, and measuring of components, the addition of ingredients during the process, weighing and measuring during various stages of the processing, and the 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 proper performance is adequately checked by one (1) or more competent individuals. The written record of the significant steps in the process shall be identified by the individual performing these tests and by the individual charged with checking these steps. Such identifications shall be recorded immediately following completion of such steps.

(2) All containers and equipment used during the production of a batch of amygdalin (laetrile) 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) To minimize contamination and prevent mixups, equipment, utensils, and containers shall be thoroughly and appropriately cleaned and properly stored and have previous batch identification removed or obliterated between batches or at suitable intervals in continuous production operations.

(4) Appropriate precautions shall be taken to minimize microbiological and other contamination in the production of amygdalin (laetrile) purporting to be sterile or which by virtue of its intended use should be free from objectionable microorganisms.

(5) Appropriate procedures shall be established to minimize the hazard of cross-contamination of the product while being manufactured or stored.

(6) To assure the uniformity and integrity of the product, there shall be adequate 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 appropriate intervals using suitable equipment.

(7) Representative samples of all dosage forms of amygdalin (laetrile) shall be tested to determine their conformance with the specifications for the product before distribution.

(8) Procedures shall be instituted whereby review and approval of all production and control records, including packaging and labeling, shall be made prior to the release or distribution of a batch. A thorough investigation of any unexplained discrepancy or the failure of a batch to meet any of its specifications shall be undertaken whether or not the batch has already been distributed. This investigation shall be undertaken by a competent and responsible individual and shall extend to other batches of the same product and other ingredients that may have been associated with the specific failure. A written record of the investigation shall be made and shall include the conclusions and followup.

(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 amygdalin (laetrile), the returned goods shall be destroyed or subjected to adequate examination or testing to assure that the material meets all appropriate standards or specifications before being returned to stock for warehouse distribution or repacking. If the product is neither destroyed nor returned to stock, it may be reprocessed provided the final product meets all 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 with the requirements of paragraph (8) of this section.

(10) Filters used in the manufacture, processing, or packaging of components of amygdalin (laetrile) for parenteral injection in humans shall not release fibers into such products. No asbestos-containing or other fiber-releasing filter may be used in the manufacture, processing, or packaging of such products. Filtration, as needed, shall be through a non-fiber-releasing filter. For the purpose of this regulation a non-fiber-releasing filter is defined as non-asbestos filter that, after any appropriate pre-treatment 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 (3) times greater than its width.

Kan. Admin. Regs. § 28-21-255

Authorized by K.S.A. 1978 Supp. 65-6b06, 65-6b07; effective May 1, 1979.