Operations in the pharmaceutical industry are complex—and rightly so. Pharmaceutical
packaging is no exception. Vast amounts
of information are required to be
present on any given pharmaceutical
product. But with so much information
squeezed into that tiny space, there is
always the risk that the packaging could
potentially harbor a number of errors
that can render the product defective and
mandate its removal from the market.
Mike Malz, Marketing & Creative
Director of GlobalVision, participated in
an exclusive Q&A with Pharmaceutical
Processing on best practices for print
inspection in the pharmaceutical industry.
His edited responses are below.
Q. To start, what are the various
elements that must be displayed on
a pharmaceutical package (cartons,
labels, and package inserts)?
Mike Malz: The most important element
to display on pharmaceutical packaging is
the FDA-approved copy, which includes
legal notices, directions for use, and
disclaimers. The FDA approves the copy
as part of the regulatory process and must
appear exactly as is on the final package—
the slightest difference can mean a recall
from the market.
Graphics can be included, particularly
in the case of branded products vs.
generic alternatives. It’s also often used
in instructions for use to show the user
how to use the product, particularly for
injectables and medical devices.
Barcodes are another important element
in packaging. Pharmaceutical drugs are
expensive products and (consequently) prone
to counterfeiting. To ensure patient safety,
barcodes are used to encode unique serial
numbers and lot numbers to ensure drugs
are tracked and traced to guarantee they
are the original product. The pharmaceutical
barcode is the primary barcode and serves
as the key identifier of the drug.
This is followed by the UPC code which
is the key identifier for point-of-sale.
Other barcodes may also be present
for print production, tracking, and ID.
We rely heavily on barcodes in today’s
marketplace, and the use of multiple
barcodes on a pharmaceutical package
makes for an element that proves most
complex, and crucial to manage.
Finally, Braille is a key component of
pharmaceutical packaging in European
markets, where it is mandatory to include
the product names for the blind with the
EU Directive 2001/83/EC.
◗ By Meg LaTorre-Snyder
Exclusive Q&A with GlobalVision on print inspection
best practices in the pharmaceutical industry.