Pharmaceutical Commerce - May/June 2017 - 24

Supply Chain/Logistics
2017 Product Security Report
Traceability efforts forge ahead, anticounterfeiting technologies are reviving, and cargo security becomes a more settled practice
Pharmaceutical Commerce has used the term
'Year Zero' in talking about 2017 and the deadlines for
compliance with the US Drug Supply Chain Security Act,
simply because the key next step-having a unique serial
number on each package of product leaving packaging
lines-must be met by November 27. Previous deadlines,
for lot-level tracking and for reporting various bits of
information to regulators, have mostly been met, while
future deadlines-tracing pharmaceutical shipments all the
way from point of dispensing back, and a fully electronic,
interoperable traceability system-are contingent on this
serialization step. And because so many pharma companies
around the world ship product to the US (and thus have
to be compliance with DSCSA themselves), along with the
national traceability efforts going on in some 40 countries
globally, the US effort is something of a hinge that will shift
worldwide pharmaceutical security practices.
In particular, the Falsified Medicines Directive
(FMD) within the European Union has a February 2019
deadline for serialization combined with national or panEuropean data collection, to secure distribution of drugs
that routinely cross national borders there, and/or are
repackaged for cross-border sales. Beyond the EU, "the
serialization efforts going on in China, Brazil and Russia
have all picked up pace recently," notes Brian Daleiden, VP,
industry marketing, at TraceLink, a leading software vendor
in the field. "Additionally, India, which has one serialization
program for export, and another for domestic traceability,
is making progress."
The internationalization of pharma traceability is one
key reason why speculation about the US program's future
course is more settled. With the arrival of the Trump
administration, there has been speculation that DSCSA
provisions could be delayed or even cancelled; however,
with traceability as a global priority (and with US-based
companies concerned with export of their products), there
has been little to no resistance by the pharma industry to
DSCSA compliance.

Fig. 1. Industry has a long hill to climb for DSCSA compliance

It is highly likely, however, that 100% compliance with
the serialization mandate will not be met come November.
Numerous programs at pharma companies and their
contract manufacturing/packaging organizations (CMOs)
are only just getting started; most industry experts say a
time frame of up to 18 months is needed for a well-thoughtout program. FDA has had a pattern with previous DSCSA
milestones of using "enforcement discretion" in applying
its deadlines; the likelihood is that this will also occur come
November. "There are plenty of Big Pharma companies
who are not complete with their serialization projects," says
John Jordon, VP, business strategies, at Vantage Consulting
Group, a Hillsborough, NJ firm performing traceability
implementations and other types of manufacturing
automation. "The real crunch will occur with virtual
pharma firms who are dependent on CMOs," which makes
that choice a critical one for the virtual company.

24 Visit our website at www.PharmaceuticalCommerce.com May | June 2017

On the other hand, many major pharma companies are
well along with their programs. "We have been packaging
and distributing serialized product for more than three
years in the US," says Mike Rose, VP, supply chain visibility,
at Johnson & Johnson. "We have conducted several
pilots with our wholesaler customers and are starting
to use serialization data to assess and validate returned
products. This information gives us insight into movement
of product in the supply chain."
J&J is also moving along the "beyond compliance" path,
where businesses are expecting to derive value from their
traceability programs. "We are investigating additional
appropriate use cases in the areas of brand protection,
brand marketing programs, sample management and
customer connectivity," says Rose.
Fast startup
The picture is different at many CMOs. While major
players like PCI, Sharp Packaging and others not only
have implementations in place, but are promoting their
serialization services as a premium offering for manufacturers,
others are just getting started. For the past six months or so,
vendors of serialization equipment (the barcoding applicator
and the machine-vision system for checking barcode quality,
along with digital communications equipment to receive
and transmit serial data). Systech promotes a 'Serialize by
November' program that includes site and line management
configuration, factory acceptance testing, and site acceptance
testing, with an offer that future technical requirements will
be met with no additional purchases. Optel Vision offers
the Fast Series of five individual stations, for serializing and
packing items or cases, with manual, semiautomatic or fully
automatic functionality, and a promise to deliver within six
weeks.
Vantage's Jordon mentions another factor being contested
among buyers of serialization equipment: aggregation. The
term refers to the ability to match the unique serial codes
of a few (or few dozen) packages inside a shipping case,
with the unique code of the case itself. Wholesalers are
demanding aggregation for the most efficient processing
of deliveries inside their distribution centers; without it,
each case would need to be opened to verify its contents.
However, aggregation is not part of DSCSA compliance. By
some industry estimates, incorporating aggregation into a
packaging line can double the cost of an implementation on
that line. "It's entirely feasible to do serialization to meet the
November deadline without aggregation," he says, "but it will


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Table of Contents for the Digital Edition of Pharmaceutical Commerce - May/June 2017

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Pharmaceutical Commerce - May/June 2017 - Cover2
Pharmaceutical Commerce - May/June 2017 - Table of Contents
Pharmaceutical Commerce - May/June 2017 - 4
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Pharmaceutical Commerce - May/June 2017 - Cover4
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