Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 21 - FOOD, DRUGS AND COSMETICS › Section 28-21-255 - Production and control procedures

Current through Register Vol. 43, No. 28, July 11,
			 2024
(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.