Kan. Admin. Regs. § 28-21-258 - Laboratory controls
Laboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards, and test procedures to assure that components, in-processed drugs, and finished products conform to appropriate standards of identity, strength, quality and purity. Laboratory controls shall include:
(1) The establishment of master records
containing appropriate specifications for the acceptance of each lot of the
components, product containers, and their components used in the production and
packaging and description of the sampling and testing procedures used for them.
Said samples shall be representative and adequately identified. Such record
shall also provide for appropriate retesting of the components, product
containers, and their components subject to deterioration.
(2) A reserve sample of all active
ingredients is required.
(3) The
establishment of master records, when needed, containing specifications and a
description of sampling and testing procedures for in-process amygdalin
(laetrile) preparations. Such samples shall be adequately representative and
properly identified.
(4) The
establishment of master records containing a description of sampling procedures
and appropriate specifications for finished products. Such shall be adequately
representative and properly identified.
(5) Adequate provisions for checking the
identity and strength of amygdalin (laetrile) for all active ingredients and
for assuring:
(A) Sterility of amygdalin
(laetrile) purported to be sterile and freedom from objectionable
micro-organisms for those products which should be so by virtue of their
intended use.
(B) The absence of
pyrogens for those products purporting to be pyrogen-free.
(C) That the release pattern of sustained
release products is tested by laboratory methods to assure conformance to the
release specifications.
(6) Adequate provision for auditing the
reliability, accuracy, precision, and performance of laboratory test procedures
and laboratory instruments used.
(7) A properly identified reserve sample of
the finished product (stored in the same immediate container-closure system in
which the product is marketed) consisting of at least twice the quantity
necessary to perform all the required tests, except those for sterility and
determination of the absence of pyrogens, and stored under conditions
consistent with product labeling shall be retained for at least two (2) years
after distribution has been completed or one (1) year after the product's
expiration date, whichever is longer.
(8) Provision for retaining complete records
of all laboratory data relating to each batch or lot of amygdalin (laetrile) to
which they apply. Such records shall be retained for at least two (2) years
after distribution has been completed or one (1) year after the product's
expiration date, whichever is longer.
(9) Provision that animals shall be
maintained and controlled in a manner that assures suitability for their
intended use. They shall be identified and appropriate records maintained to
determine the history of use.
(10)
Provision that firms which manufacture non-penicillin products (including
certifiable antibiotic products) on the same premises or use the same equipment
as that used for manufacturing penicillin products, or that operate under any
circumstances that may reasonably be regarded as conducive to contamination of
other products by penicillin, shall test such non-penicillin products to
determine whether any have become cross-contaminated by penicillin. Such
products shall not be marketed if intended for use in man and the product is
contaminated with an amount of penicillin equivalent to 0.05 (five one
hundredths) unit or more of penicillin G per maximum single dose recommended in
the labeling of a product intended for parenteral administration, or an amount
of penicillin equivalent to 0.5 (five one tenth) unit or more of penicillin G
per maximum single dose recommended in the labeling of a product intended for
oral use.
Notes
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