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-1531 - Packaging and Labeling [formerly paragraph 6:208]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Packaging and labeling operations shall be
				controlled to assure that only those products that have met the standards and
				specifications in their master production and control records shall be
				distributed; to prevent mix-ups between drugs during filling, packaging and
				labeling operations to assure that correct labels and labeling are employed for
				the drug and to identify the finished product with a lot or control number that
				permits determination of the history of the manufacture and control of the
				batch. An hour, day or shift code is appropriate as a lot or control number for
				drug products manufactured or processed in continuous production equipment.
				Packaging and labeling operations shall:
1.
				[formerly paragraph 6:208-1] be separated (physically or spatially) from
				operations on other drugs in a manner so as to avoid mix-ups and minimize
				cross-contamination. Two or more packaging or labeling operations having drugs,
				containers or labeling similar in appearance shall not be in process
				simultaneously on adjacent or nearby lines unless these operations are
				separated physically or spatially;
2. [formerly paragraph 6:208-2] provide for
				an inspection of the facilities prior to use to assure that all drugs and
				previously used products and labeling materials have been removed;
3. [formerly paragraph 6:208-3] include the
				following labeling controls:
a. [formerly
				paragraph 6:208-3 (1)] the holding of labels and package labeling upon receipt
				pending review and proofing against an approved final copy to assure that they
				are accurate regarding identity, and content before release to
				inventory;
b. [formerly paragraph
				6:208-3 (2)] the maintenance and storage of each type of label and package
				labeling representing different products, strength, dosage forms or quantity of
				contents in such a manner as to prevent mix-ups and provide
				identification;
c. [formerly
				paragraph 6:208-3 (3)] a system for assuring that only current labels and
				package labeling are retained and that stocks of obsolete package labeling are
				destroyed;
d. [formerly paragraph
				6:208-3 (4)] restriction of access to labels and package labeling to authorized
				personnel;
e. [formerly paragraph
				6:208-3 (5)] avoidance of gang printing of cut labels, cartons or inserts when
				the labels, cartons or inserts are for different products or different
				strengths of the same products or are of the same size and have identical or
				similar format and/or color schemes. If gang printing is employed, packaging
				and labeling operation shall provide for added control procedures. These added
				controls should consider sheet layout, stacking, cutting and handling during
				and after printing;
4.
				[formerly paragraph 6:208-4] provide for strict control of the package labeling
				issued for use with the drug. Such issue shall be carefully checked by a
				competent individual for identity and conformity to the labeling specified in
				the batch production. Said individual shall reconcile any discrepancy between
				the quantity of the drug finished and the quantities of labels
				issued;
5. [formerly paragraph
				6:208-5] provide for examination or laboratory testing of samples of finished
				product after packaging and labeling to safeguard against any errors in the
				finished operation and to prevent distribution of any batch until all tests
				have been met.