Pharmaceutical Commerce - June 2018 - 7

OV E RV I E W

along
authentication makes a comeback, and cargo security goes digital

According to sources, six or seven
EU countries have their national
system in place as of late spring;
and among manufacturers,
repackagers, and some
distributors (who have partial
responsibilities to reporting data),
readiness is spotty.

Barcodes and serial
numbers

TRACEABILITY SOFTWARE BY LEVEL
Any conversation today about pharma traceability software has solidified
around four "levels" as codified in the past by ISA, a US professional
association, and ISO, the international standards body.
LEVEL 1 Packaging line device (cameras, printers) management
LEVEL 2 Line level (packaging line) management

LEVEL 3 Site (multiple packaging lines) management
For the past three years, the
bulk of spending on pharma
LEVEL 4 Enterprise (multiple sites; external communication) management
traceability has been by
manufacturers and contract
Some representatives like to talk about "Level 5" as reporting to
packagers, installing machine
government authorities, but this isn't strictly a part of the industry
vision systems, barcode
standard terminology. Most machine-vision or packaging vendors offer
printers and varying degrees
a Level 1-3 solution; most Level 4 providers don't deal with lower levels,
of automation for case packing
but there are exceptions in both cases.
and palletizing . Packag ing
equipment vendors have
affect product acceptance by trading partners); however,
responded with a growing variety of flexible machines,
industry surveys by HDA and others point to nagging
especially to handle both automated, semi-automated and
inconsistencies in this area, including printing the wrong
manual case-packing. The argument over aggregation-the
information or in the wrong location. These problems are
need for a shipper to provide 100% accurate linking of
expected to clear up quickly.
the serial codes within a case, to the serial code of the case
Contract packagers have an added burden in traceability:
itself-seems to be settling down, since most companies
dealing with the variety of technology and businessagree that it is more economical to include aggregation as
practice policies of multiple clients. Robert Madden, Global
part of a packaging line serialization project. (Aggregation
Serialisation Operational Manager at Almac Group (which
is not a requirement of DSCSA; however, the leading US
has operations in both the US and Europe), says that "Some
wholesalers make delivering aggregated cases a requirement,
clients have a defined serialization strategy, some want to
since otherwise they would have to open each case and
send Almac serial numbers and then others want Almac
visually inspect the contents, which could slow down product
to guide them on the best approach." The company goes
movement considerably.)
through a seven-step process (including carton artwork
No machine-vision or barcode-printing vendor will
and labels) to arrive at a project plan, and then executes.
admit to problems with barcode print quality (which could

06.2018 / Visit our website at www.PharmaceuticalCommerce.com / 7


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Table of Contents for the Digital Edition of Pharmaceutical Commerce - June 2018

Table of Contents
Pharmaceutical Commerce - June 2018 - Cover1
Pharmaceutical Commerce - June 2018 - Cover2
Pharmaceutical Commerce - June 2018 - Table of Contents
Pharmaceutical Commerce - June 2018 - 4
Pharmaceutical Commerce - June 2018 - 5
Pharmaceutical Commerce - June 2018 - 6
Pharmaceutical Commerce - June 2018 - 7
Pharmaceutical Commerce - June 2018 - 8
Pharmaceutical Commerce - June 2018 - 9
Pharmaceutical Commerce - June 2018 - 10
Pharmaceutical Commerce - June 2018 - 11
Pharmaceutical Commerce - June 2018 - 12
Pharmaceutical Commerce - June 2018 - 13
Pharmaceutical Commerce - June 2018 - 14
Pharmaceutical Commerce - June 2018 - 15
Pharmaceutical Commerce - June 2018 - 16
Pharmaceutical Commerce - June 2018 - 17
Pharmaceutical Commerce - June 2018 - 18
Pharmaceutical Commerce - June 2018 - 19
Pharmaceutical Commerce - June 2018 - 20
Pharmaceutical Commerce - June 2018 - 21
Pharmaceutical Commerce - June 2018 - 22
Pharmaceutical Commerce - June 2018 - 23
Pharmaceutical Commerce - June 2018 - 24
Pharmaceutical Commerce - June 2018 - 25
Pharmaceutical Commerce - June 2018 - 26
Pharmaceutical Commerce - June 2018 - 27
Pharmaceutical Commerce - June 2018 - 28
Pharmaceutical Commerce - June 2018 - 29
Pharmaceutical Commerce - June 2018 - 30
Pharmaceutical Commerce - June 2018 - 31
Pharmaceutical Commerce - June 2018 - 32
Pharmaceutical Commerce - June 2018 - 33
Pharmaceutical Commerce - June 2018 - 34
Pharmaceutical Commerce - June 2018 - Cover3
Pharmaceutical Commerce - June 2018 - Cover4
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http://www.nxtbook.com/nxtbooks/pharmcomm/20091112
http://www.nxtbookMEDIA.com