Current through Register Vol. 43, No. 12, March 20,
2024
(a) Packaging and
labeling operations shall be adequately controlled, to assure that only those
products that have met the standards and specifications established in their
master production and control records shall be distributed; to prevent mixups
between products during filling, packaging, and labeling operations; to assure
that correct labels and labeling are employed for the product; 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 all products manufactured or
processed in continuous production equipment. Packaging and labeling operations
shall:
(1) Be separated (physically or
spatially) from operations on other drugs in a manner adequate to avoid mixups
and minimize cross-contamination. Two (2) or more packaging or labeling
operations having amygdalin (laetrile) and other drugs, containers, or labeling
similar in appearance shall not be in process simultaneously on adjacent or
nearby lines unless these operations are separated either physically or
spatially.
(2) Provide for an
inspection of the facilities prior to use to assure that all drugs and
previously used packaging and labeling materials have been removed.
(3) Include the following labeling controls:
(A) The holding of labels and package
labeling upon receipt pending review and proofing against an approved final
copy by a competent and responsible individual to assure that they are accurate
regarding identity, content, and conformity with the approved copy before
release to inventory.
(B) The
maintenance and storage of each type of label and package labeling representing
different products, strength, dosage forms, or quantity of contents in such
manner as to prevent mixups and provide proper identification.
(C) A suitable system for assuring that only
current labels and package labeling are retained and that stocks of obsolete
labels and package labeling are destroyed.
(D) Restriction of access to labels and
package labeling to authorized personnel.
(E) 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 or color schemes. If gang printing is
employed, packaging and labeling operations shall provide for added control
procedures. These added controls should consider sheet layout, stacking,
cutting, and handling during and after printing.
(4) Provide strict control of the package
labeling issued for use with amygdalin (laetrile). Such issue shall be
carefully checked by a competent and responsible person for identity and
conformity to the labeling specified in the batch production record. Said
record shall identify the labeling and the quantities issued and used and shall
reasonably reconcile any discrepancy between the quantity of amygdalin
(laetrile) finished and the quantities of labeling issued. All excess package
labeling bearing lot or control numbers shall be destroyed. In event of any
significant unexplained discrepancy, an investigation should be carried out.
(5) Provide for adequate
examination or laboratory testing of representative samples of finished
products after packaging and labeling to safeguard against any errors in the
finishing operations and to prevent distribution of any batch until all
specified tests have been met.
