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-1521 - Components [formerly paragraph 6:202]

Current through Register Vol. 50, No. 6, June 20, 2024
A. All components and other materials used in
				the manufacture, processing and packing of drug products, and materials
				necessary for building and equipment maintenance, shall upon receipt be stored
				and handled in a safe, sanitary and orderly manner to assure safety, purity and
				strength. Precautions shall be taken to prevent mix-ups and cross-contamination
				affecting drugs and drug products. Components shall be held from use until they
				have been identified, sampled and tested for conformance to established
				specifications and are released by a material approval unit. Controls of
				components shall include the following.
1.
				[formerly paragraph 6:202-1] Each container of component shall be examined
				visually for damage or contamination prior to use, including examination for
				breakage of seals, when indicated.
2. [formerly paragraph 6:202-2 ] Samples
				shall be taken from component containers from each lot and shall be subjected
				to one or more tests to establish their specific identity.
3. [formerly paragraph 6:202-3] Samples of
				components liable to contamination with filth, insect infestation or other
				extraneous contaminants shall be appropriately examined.
4. [formerly paragraph 6:202-4] Samples of
				components liable to microbiological contamination shall be subjected to
				microbiological test prior to use. Such components shall not contain
				microorganisms that are objectionable in view of their intended use.
5. [formerly paragraph 6:202-5] Samples of
				all components intended for use as active ingredients shall be tested to
				determine their strength in order to assure conformance with specifications
				approved by the state health officer.
6. [formerly paragraph 6:202-6] Components
				which have previously been approved shall be identified and retested as
				necessary to assure that they continue to meet specifications:
a. [formerly paragraph 6:202-6 (1)]
				Components which have been approved shall be handled and stored to guard
				against contamination or being contaminated by other drugs or
				components.
b. [formerly paragraph
				6:202-6 (2)] Components which have been approved shall be rotated in such a
				manner that the oldest stock is used first.
c. [formerly paragraph 6:202-6 (3)] Rejected
				components shall be identified and held to preclude their use in manufacturing
				or processing procedures for which they are unsuitable.
7. [formerly paragraph 6:202-7] Records shall
				be maintained for at least two years after distribution has been completed, or
				one year after the drug's expiration date, whichever is longer. Such records
				shall include:
a. [formerly paragraph 6:202-7
				(1)] the identity and quantity of the component, the name of the supplier, the
				supplier's lot number and the date of receipt;
b. [formerly paragraph 6:202-7 (2)]
				examinations and tests performed, and rejected components and their
				disposition;
c. [formerly paragraph
				6:202-7 (3)] an individual inventory and record for each component used in each
				batch of drug manufactured or processed.
8. [formerly paragraph 6:202-8] An 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 pyrogens, shall be retained for at least two years after
				distribution of the last drug lot incorporating the component has been
				completed, or one year after the expiration date of this last drug lot,
				whichever is longer.