Pharmaceutical Commerce - November/December 2016 - 20


Supply Chain/Logistics
Pharma traceability:
year in review
The tempo of project work is accelerating to meet deadlines in
2017 and beyond
By Nicholas Basta

2017 is going to be a busy year for
traceability initiatives in the US and
abroad, as manufacturers and packagers
get more experience under their belts
in installing the necessary serialization
equipment, and wholesalers and other
trading partners are making initial forays
into actually using the data that traceability
mandates are generating. In the US, the
deadline is late November 2017, when-by
law-all US-packaged pharmaceuticals are to
have a "serialized numeric identifier" (SNI)
in place, at the unit-of-use level. This is one of
several upcoming deadlines under the 2013
Drug Supply Chain Security Act (DSCSA).
China, South Korea and India are wrestling
with their own internal systems, while Brazil
has put a hold on its program until next year.
In Europe, the Falsified Medicines
Directive (FMD), an EU-wide mandate
(with several other European countries-
including Great Britain post-Brexit-also
complying) has an early 2019 deadline for a
first stage of compliance. Several European
trade associations have already organized
as the European Medicines Verification
Organisation (EMVO), and the initial stages
of a European Hub for transmitting serial
identification data among member countries
have been taken, with early 2017 as a target
for operational capabilities of the Hub to be
in place.
So far, so good. Despite such mandates,
FDA is months overdue in producing
guidance documents based on DSCSA. In
a presentation at an FDA DSCSA public
hearing in mid-October, Anita Ducca,
SVP of regulatory affairs at the Health
Distribution Alliance (formerly HDMA),
voiced concern that this overdue guidance
is gumming up some basic documentation
processes for DSCSA. "The lack of federal
licensure regulations [is leading to] state
inspectors and state boards developing
different interpretations and requirements
that are inconsistent with the DSCSA and
with each other. And once the federal
regulations do issue, states will have to go
back and amend what they've just changed,
creating additional stresses for the states'
limited resources, as well."
Meanwhile, the FMD, which is supposed
to combine serial item data with product
master data (that is, a description of what it
is that has been serialized) is dependent on
a different program, the Identification of
Medicinal Products (IDMP), which is being
managed as an effort of the International
Standards Organization (ISO). That effort is
proceeding on its own timetable, and EMVO
says that its availability when the FMD
is supposed to be in place remains "to be
determined."
Two other oper ational standards

bear mentioning: at press time, the
GS1 organization (a nongovernmental
organization whose participants are most
of the barcoding users and suppliers in the
world) was about to release version 1.2 of
its EPCIS standard. EPCIS provides the
definitions and coding procedures for how
traceability and identification information
are to be shared among trading partners
and government agencies. Peter Sturtevant,
senior director at the GS1 US organization,
notes that this EPCIS v1.2 will have 152
examples of exception management
(unaccounted-for disconnects between the
flow of product through supply chains and
the flow of identification and transaction
information that is supposed to accompany
it), given clear evidence of how complicated
pharmaceutical distribution is about
to become. GS1 Healthcare has a process
for certifying compliance with the EPCIS
standards, but this measure of performance is
only sporadically being followed by vendors
in the field.
Another industry-led initiative, the Open
Serialization Communication Standard, or
Open-SCS, now has two more members
(Arvato Systems and TradeTicity) in
addition to the 13 it had in August, when
a press release updating its activities was
issued. (The 13 members onboard then
were Abbott, Advanco, Antares Vision,
OCS Checkweighers, Omron, Optel Vision,
Roche, Pfizer, SAP, Systech, Teva Pharma,
TraceLink and Werum IT Solutions.) OpenSCS is an effort to address interfacing
issues among the equipment used for
serialization: machine vision systems, casepacking machinery, labeling devices and
the like. Like EPCIS, Open-SCS seeks to
establish a common interfacing protocol for
serialization (at least at the packaging line
level), but it's an open question whether the
standard will be in place before the bulk of

TraceLink has assessed how unit serialization affects DSCSA
compliance data-reporting requirements. Credit: TraceLink

packaging line equipment has been put on
order by manufacturers.
Given the complexity of all these efforts,
it's no surprise that when industry experts
looked at the California e-pedigree rules that
were supposed to go into effect in 2009 they
were pushed off to (at that time) 2015. When
the DSCSA federal law was passed in 2013, its
full implementation was to be staged year by
year through 2023. The industry, FDA and
the various nations taking on this task will be
hard-pressed to have a functioning system by
the early 2020s.
Which is not to say that the pharma
industry is standing pat on serialization and
traceability. Some 15% of the 10,000 (or
more) packaging lines for pharmaceuticals
have been fitted out with the barcoding
and data-collection systems, according
to informal polling of industry insiders.

Serialization is a multi-step, multi-event process on the packaging line.

20 Visit our website at www.PharmaceuticalCommerce.com November | December 2016

Systech, Optel, Antares Vision and others
that supply the line-level machine vision
systems have all expanded over the past
year, and the battles among the vendors
is going hot and heavy right now. Some
reports of months-long delays in getting the
necessary machinery are already beginning
to crop up as the November 2017 deadline
in the US approaches.
The big question before packaging
and manufacturing engineering teams at
the moment is whether to install so-called
aggregation equipment at this time.
Aggregation addresses the realities of how
pharmaceuticals are shipped-generally,
in cases that hold 24 to 100 or so units of
the drug product. As each unit has its own
serialization number, and as DSCSA requires
pharma trading partners to verify that those
specific serial numbers have been received,
wholesalers and others are concerned that,
without an aggregation step, they will be
obliged to open each case and manually verify
its contents. With an accurate aggregation,
wholesalers want to be able to infer the
contents of the case. However, aggregation/
inference is not mandated by DSCSA.
An excellent example of a packaging line
with aggregation was highlighted by Antares
Vision this summer* for an unnamed
pharma client (packaging and labeling
vendors Domino, Cognex, Omega Design,
ESS Technologies and Weiler Labeling
Systems were also involved). The 24 pill
bottles that make up a bundle of product
are each barcoded on their bottoms with
a "helper code" linked digitally to the
*http://pharmaceuticalcommerce.com/manufacturingand-packaging/addressing-aggregation-problempharma-traceability/


http://pharmaceuticalcommerce.com/manufacturing-and-packaging/addressing-aggregation-problem-pharma-traceability/ http://pharmaceuticalcommerce.com/

Table of Contents for the Digital Edition of Pharmaceutical Commerce - November/December 2016

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Pharmaceutical Commerce - November/December 2016 - Table of Contents
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Pharmaceutical Commerce - November/December 2016 - Cover4
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