Feature
Best Practices in Serialization
Seven essentials can help companies execute serialization strategies across
multiple product lines, multiple packaging lines, and regional markets around
the world.
The world of pharmaceutical packaging is replete with confusing
and disruptive market conditions.
One of the most daunting challenges
today involves assessing and addressing new global regulatory requirements and the shifting timelines for
serialization. There are immediate,
intermediate, and future regulations
that are, literally and figuratively, all
over the map—and the calendar. For
instance, immediate requirements
such as French CIP13 coding or those
emerging from the Turkish Ministry of
Health appear to be vastly disparate
technologies with varying deadlines for
compliance.
Other regulatory bodies in Europe,
South America, and Asia are quickly
following suit with their own requirements for pharmaceutical tracking and
reimbursement initiatives. Amid the
flurry of country-specific initiatives,
the European Commission has proposed legislation to prevent counterfeit
products from entering the legal supply
chain, and the U.S. FDA has issued
guidance for the creation of Standardized Numerical Identifier (SNI)
legislation.
Pharmaceutical manufacturers need
to meet current regulatory requirements and implement plans to prepare them for whatever the global
regulatory tides bring. “Manufacturers
facing this diverse regulatory environment are often tempted to default to
tactical solutions that address short-term requirements. Manufacturers
can instead adopt a comprehensive
approach based on productized solu-
tions that addresses regional needs
today but also provides scalability for
future needs,” according to Joe Ringwood, COO, Systech International.
Systech, a developer of Packaging
Execution Systems (PES), has more
than two decades of experience in
vision inspection, line management,
and serialization deployments for the
A solution for enabling serialization, such as
Systech’s Serialized Product Tracking application or (SPT), includes many different components. The solution maintains control over
serialization at the item, bundle, case, and
pallet levels.
pharmaceutical industry. The company currently has 150 serialization
lines installed, in process, or under
contract worldwide. As a result of its
experience, Systech has identified a
list of seven “Lessons Learned” to help
companies plan for this disruptive
environment. These lessons should be
considered when planning a serialization initiative.
1. Serialization is a business
strategy. While regulatory compliance is a major driver for serialization
projects, leading pharmaceutical com-
panies are unlocking additional value
by taking a comprehensive approach.
Successful manufacturers develop
enterprisewide strategies encompassing packaging, information technology
(IT), and other disciplines. These strategies address the organization’s view
of serialization from the standpoint
of patient safety, brand protection,
and supply-chain operations. Industry leaders recognize that individual
drivers, such as country-specific regulatory requirements, may drive local
requirements and timing, but the overall adoption of serialization is strategic
to the enterprise.
New regulatory requirements
are often fluid and unpredictable in
terms of enactment and enforcement.
For example, some manufacturers
viewed last year’s delay in California’s
e-pedigree requirements as an opportunity to shelve serialization projects.
However, many leading pharmaceutical packagers simply adjusted the focus
of their deployments from North
America and compliance to Europe
and brand protection. Companies with
a serialization business strategy have
more control of their destiny and will
likely be positioned to unlock potential
future benefits.
2. Serialization must be a
cross-functional endeavor.
Serialization is not just a project for an
individual functional organization or
location. As mentioned earlier, serialization is disruptive and requires
changes and planning in packaging,
quality control, distribution, and IT,
