Louisiana Administrative Code
Title 51 - PUBLIC HEALTH-SANITARY CODE
Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics
Chapter 15 - Current Good Manufacturing Practices in the Manufacture of Drugs
Section VI-1525 - Laboratory Controls [formerly paragraph 6:204]
Universal Citation: LA Admin Code VI-1525
Current through Register Vol. 50, No. 9, September 20, 2024
A. Laboratory controls shall include the establishment of scientifically sound specifications, standards and test procedures to assure that the components, in-processed drugs and finished products conform to standards of identity, strength, quality and purity. Laboratory controls shall include requirements listed in §1525. A 1-10:
1. [formerly paragraph 6:205-1] the
establishment of master records containing specifications for the acceptance of
each lot of components, product containers and their components used in drug
production and packaging and a description of the sampling and testing
procedures used for them. Such records shall also contain provisions for
retesting of drug components, product containers and their components which are
subject to deterioration;
2.
[formerly paragraph 6:205-2] a reserve sample of all active ingredients as
required by §1521;
3. [formerly
paragraph 6:205-3] the establishment of master records containing
specifications and a description of sampling procedures for in-process drug
preparations;
4. [formerly
paragraph 6:205-4] the establishment of master records containing a description
of sampling procedures and appropriate specifications for the finished drug
product;
5. [formerly paragraph
6:205-5] provisions for checking the identity and strength of a drug product
for all active ingredients and for assuring:
a. [formerly paragraph 6:205-5 (1)] sterility
of drugs purported to be sterile; and freedom from objectionable microorganisms
(such as the known common pathogens and others which might affect safety,
strength and purity) for those drugs which should be so by virtue of their
intended use;
b. [formerly
paragraph 6:205-5 (2)] the absence of pyrogens for those drugs purporting to be
pyrogen-free;
c [formerly paragraph
6:205-5 (3)] minimal contamination of ophthalmic ointment by foreign particles
and harsh or abrasive substances;
d. [formerly paragraph 6:205-5 (4)] that the
drug release pattern of sustained-release products is tested by laboratory
methods to assure conformance to release specifications;
6. [formerly paragraph 6:205-6] provisions
for auditing the reliability, accuracy, precision and performance of laboratory
instruments and test procedures;
7.
[formerly paragraph 6:205-7] a n identified reserve sample of the finished
product (stored in the same immediate container-closure system in which the
drug is marketed) consisting of at least twice the quantity necessary to
perform all the necessary tests, except those for sterility and determination
of the absence of pyrogens, shall be stored under conditions consistent with
product labeling, and shall be retained for at least two years after
distribution has been completed or one year after the expiration date,
whichever is longer;
8. [formerly
paragraph 6:205-8] provisions for retaining complete records of all laboratory
data relating to each batch or lot of drug to which they apply. Such records
shall be retained for at least two years after distribution has been completed
or one year after the drug's expiration date, whichever is longer;
9. [formerly paragraph 6:205-9] provisions
that animals shall be maintained and controlled in a manner that assures
suitability for their intended use. They shall be identified and records
maintained to determine the history of use;
10. [formerly paragraph 6:205-10] provisions
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 be regarded as conducive to contamination of other drugs
by penicillin, shall test such non-penicillin products. 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 units or more of penicillin "G" per
maximum single dose recommended in the labeling of a drug intended for oral
use.
AUTHORITY NOTE: Promulgated in accordance with the provisions of R.S. 40:4(A)(1)(a). Also see R.S. 40:601 et seq.
Disclaimer: These regulations may not be the most recent version. Louisiana may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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