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]

Current through Register Vol. 50, No. 6, June 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.