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Key Challenges for Pedigree Authentication and Serialization
Figure 1: Base Reference Model
been demonstrated to support track-and-trace applications and
processes. Within the life sciences industry, GS1 Healthcare US and
EPCglobal are co-ordinating the development of a series of standards to
Base reference model
facilitate the RFID tagging, capture, and exchange of serialized product
information. These include the Drug Pedigree Messaging Standard
Safe and secure
supply chain
(DPMS) and the EPC Information Service (EPCIS) standard.
Issues and Objectives
Is the product
For executives within the pharmaceutical industry, the top issues will be
Authentication Pedigree
Is the chain of
genuine? custody intact?
ensuring the highest levels of both patient safety and brand protection.
Life sciences manufacturers need to adopt an enterprise-wide approach
to addressing these issues, since any incidence of counterfeiting—
Product Physical
Track Trace
particularly when it concerns life-saving drugs or devices—can reflect
identity features
poorly on the company. Thus, executives need to consider how to
Is the EPC associated Does the unit of sale Where is the product Where was the product? proactively comply with emerging serialization mandates in the US and
with the unit of have the expected and where is it headed? (locations and custodians)
sale valid? covert and/or overt
Europe while balancing the costs and benefits of serialization and
features?
authentication for the company and determining which products and
brands to prioritize.
serve as the unequivocal basis for validating the authenticity of the
products at any time or node in the supply network. This would enable Different stakeholders have different issues and objectives concerning
manufacturers, distributors, retailers, and regulatory bodies to track supply chain traceability. For example, a Chief Operating Officer will need
product movements in realtime from the smallest stock-keeping unit (a to manage company-wide risk caused by emerging mandates and
bottle, for instance) up through each level of packing—e.g. cases and consider compliance, customer satisfaction, brand protection, and
pallets. Figure 1 shows the framework schematically, and highlights the financial risk. In product manufacturing, the main issues are linking a
way to ensure both authentication and pedigree validation and therefore finished product with all the component parts and raw materials used
ensure a safe and secure supply chain. during manufacturing, as well as taking account of upstream traceability,
accuracy of recall, global visibility, and regulatory compliance. Within the
supply chain, it is vital to ensure secure distribution of products, prevent
and detect counterfeiting, and address reverse logistics, at the lowest
Within the supply chain, it is vital to
cost. In sales, track and trace will have an impact on product quality,
safety, and compliance issues, and ensure customer satisfaction.
ensure secure distribution of products,
prevent and detect counterfeiting, and
The Insider’s View
Many industries have already adopted RFID tagging as the standard way
address reverse logistics.
to ensure pedigree authentication and serialization. An overview of the
state of adoption of serialization strategies and RFID technologies within
the pharmaceutical industry is provided in the paper by Michelle Grayson
Technological Support and Steve Winkler (see pages 6–8).
The key to ensuring a safe and secure supply chain with full product
authentication and pedigree validation across the entire life-cycle of the
drug product—from point of manufacture to point of dispensing—is to
ensure that serialization and traceability are built into the supply chain,
The technology and capabilities to
manufacturing, and distribution processes. There are different ways to
achieve serial identification, with 2D barcodes being a relatively cheap achieve a safe and secure supply chain
option that require little sophisticated technology to track and trace
are available today.
(although without authentication), but in terms of scope and range
radiofrequency identification (RFID) has emerged as one of the leading
technologies. RFID allows organizations to read a large number of tags
simultaneously without line of sight or individual scanning of tags. In
addition to the use of serialized information to support pedigree and In order to best understand the process of serialization and pedigree
authentication, the unique tracking of objects (with RFID or other authentication within the life sciences industries, it is useful to examine
methods such as a barcode) is also useful for supply chain management, the experiences of Cephalon, an early adopter of RFID technology, as told
asset-tracking applications, and a host of other business processes. by Brian Brown (see pages 9–11).
RFID is being deployed in many industries, including fast-moving Finally, the major messages from these papers are examined in a final round-
consumer goods and on chips within animals (pets and cattle), and has up by Mandar Paralkar and Andy Dé that will help pharmaceutical and
4 PHARMACEUTICAL SERIALIZATION & AUTHENTICATION
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