Current through Register Vol. 50, No. 9, September 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.
AUTHORITY NOTE:
Promulgated in accordance with the provisions of
R.S.
40:4(A)(1)(a). Also see
R.S. 40:601 et
seq.
