Kan. Admin. Regs. § 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.
Notes
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No prior version found.