Kan. Admin. Regs. § 28-21-256 - Components
(a) All components
and other materials used in the manufacture, processing, and packaging of
amygdalin (laetrile), and materials necessary for building and equipment
maintenance, upon receipt shall be stored and handled in a safe, sanitary, and
orderly manner. Adequate measures shall be taken to prevent mixups and
cross-contamination affecting the components and final product. Components
shall be withheld from use until they have been identified, sampled, and tested
for conformance with established specifications and are released by a materials
approval unit. Control of components shall include the following:
(1) Each container of component shall be
examined visually for damage or contamination prior to use, including
examination for breakage of seals when indicated.
(2) An adequate number of samples shall be
taken from a representative number of component containers from each lot and
shall be subjected to one (1) or more tests to establish the specific identity.
(3) Representative samples of
components liable to contamination with filth, insect infestation, or other
extraneous contaminants shall be appropriately examined.
(4) Representative samples of all components
intended for use as active ingredients shall be tested to determine their
strength in order to assure conformance with appropriate speculations.
(5) Representative samples of
components liable to microbiological contamination shall be subjected to
microbiological tests prior to use. Such components shall not contain
microorganisms that are objectionable in view of their intended use.
(6) Approved components shall be
appropriately identified and retested as necessary to assure that they conform
to appropriate specifications of identity, strength, quality, and purity at
time of use. This requires the following:
(A)
Approved components shall be handled and stored to guard against contaminating
or being contaminated by other drugs or components.
(B) Approved components shall be rotated in
such a manner that the oldest stock is used first.
(C) Rejected components shall be identified
and held to preclude their use in manufacturing or processing procedures for
which they are unsuitable.
(7) Appropriate records shall be maintained,
including the following:
(A) The identity and
quantity of the component, the name of the supplier, the supplier's lot number,
and the date of receipt.
(B)
Examinations and tests performed and rejected components and their disposition.
(C) An individual inventory and
record for each component used in each batch of amygdalin (laetrile)
manufactured or processed.
(8) An appropriately identified reserve
sample of all active ingredients consisting of at least twice the quantity
necessary for all required tests, except those for sterility and determination
of the presence of pyrogens, shall be retained for at least two (2) years after
distribution of the last lot incorporating the component has been completed or
one (1) year after the expiration date of this last lot, whichever is longer.
Notes
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