La. Admin. Code tit. 51 § VI-1525

Current through Register Vol. 50, No. 11, November 20, 2024

Section VI-1525 - Laboratory Controls [formerly paragraph 6:204]

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.

La. Admin. Code tit. 51, § VI-1525

Promulgated by the Department of Health and Hospitals, Office of Public Health, LR 28:1254 (June 2002).

AUTHORITY NOTE: Promulgated in accordance with the provisions of R.S. 40:4(A)(1)(a). Also see R.S. 40:601 et seq.