Serialization is a method for the pharmaceuticals industry to deter counterfeit drugs from being sold or given to medical patients; it follows precepts developed by PIE, EPCIS, and PIMMS. Implementing serialization internationally is a technical challenge for pharma, requiring coordination at every step of the products' lifecycle.

1. • Cognizant 20-20 Insights
Pharma Serialization:
Managing the Transformation
By making the right investments in the right technology with the
right business partner, the pharmaceuticals ecosystem can alleviate
and hopefully eliminate the threat of counterfeit drugs to patient
safety and wellness.
Executive Summary information on leveraging global best practices
when implementing serialization. It covers:
The global pharmaceuticals industry faces
problems of counterfeiting, theft, diversion and
false returns to manufacturers. The World Health
• The need for serialization.
Organization (WHO) estimates counterfeit drugs • Key challenges for implementation.
are approximately 1% of the supply in developed • An implementation maturity model.
countries and 30% to 40% in developing coun-
tries. Though the 1% figure seems small, it consists • Our approach to serialization.
of millions of prescriptions in the U.S. alone. Serialization regulations are in place today in
Turkey, India, China, Brazil, Argentina and South
Pharmaceuticals companies and governments of
Korea; regulations are pending in the U.S., Canada
countries worldwide believe that counterfeiting
and the EU. Each nation, however, follows its own
by organized crime can be reduced significantly
guidelines/legislation — e.g., California’s e-pedigree
by implementing product serialization. Serializa-
law, U.S. FDA’s serialization guidelines, Turkey’s
tion requires a comprehensive system to track
serialization guidelines, China’s SFDA serialization
and trace the passage of prescription drugs
requirements, etc. — to curb counterfeiting and
through the entire supply chain. Every product
thus ensure patient safety. Despite differences
should be identified by a unique serial number in
in the countries’ laws, each nation’s regulations
addition to the origin, shelf life and batch number.
tend to be built around GS1 standards1 and are
This will allow the product’s lifecycle to be traced
sufficiently similar. This means pharmaceuticals
from production, through distribution and finally
companies, generally, can develop one program
to dispensation to patients at the drugstore or
that meets all global requirements. Although the
hospital.
GS1 format is the favored standard, International
Serialization needs careful assessment, diligent Organization for Standardization (ISO), Internet
planning and swift implementation. This white Engineering Task Force (IETF) and other compet-
paper offers pharmaceuticals companies critical ing standards also apply to serialization.
cognizant 20-20 insights | january 2013

2. Hierarchy of Benefits • Current business processes are very labor-
intensive and, as a result, the price paid by the
consumer for pharmaceuticals products is high.
Regulatory and • The high price of prescription drugs and the
Legislative relative ease of duplication and diversion make
them a prime target for counterfeiters.
Supply Chain Synergies
• Current and pending regulatory requirements
mandate that manufacturers deploy track and
and Efficiencies
trace tools for product movement as well as
utilize authentication tools to retain their com-
petitiveness.
Brand Protection
Serialization could result in economic benefits, as
well as improved brand protection and consumer
confidence in their medications.2
Anticounterfeiting
Supply Chain What Drives Serialization?
Serialization is not just about generating unique
serial numbers for any saleable units, but also
maintaning those identifications to provide
Patient Safety visibility and full traceability within the supply
chain. It requires collaborative action from
partners throughout the supply chain for accurate
recording, tracking and managing of data as the
Figure 1 product moves from manufacturer to distributor
to the dispensing point.
Why Serialization?
Serialization: Implementation Challenges
Serialization is fast becoming a necessity for
Managing and administering serialization is a
the pharmaceuticals industry (see Figure 2) as a
complex process that leads to additional cost if
result of the following factors:
not managed properly. Key operational challenges
• Ahighly complex distribution network from include:
manufacturer to consumer in which products
change hands as many as 10 times. • Creation of unique serialization codes for
individual products during the production
• The authentication of the product at various process.
levels in the supply chain becomes very difficult
without data sharing across the supply chain.
Factors Necessitating Product Serialization
Product Mix-up Counterfeiting Gray Marketing Pharmaceuticals
The risk of the Manufacturing of Unauthorized Impact
wrong product inferior copies of a distribution of • Loss in revenue.
being put into genuine “branded” branded • Loss in profit.
distribution. product labeled with products. • Loss in brand equity.
the original brand • Potential lawsuits.
name.
Figure 2
cognizant 20-20 insights 2

3. • High-speedprinting and verification of the The serialization system is expected to perform
codes generated. the following higher-level workflows:
>> Production rates up to 500 units per min- • Organizing and managing serial numbers for
ute, as well as dust- and vibration-prone the entire system.
packaging lines makes printing and verifi-
cation challenging. • Ensuring number uniqueness and randomness
via integrated algorithms.
• Cross-site coordination for serial generation
for similar product lines. • Assigning the numbers to a batch.
• Integration with enterprise systems. • Passing serial numbers on to the serialization
line system (SLS) for further processing.
• Optimum utilization of existing technologies/
machineries. • Maximizing the use of serialization assets that
are required by most geographies.
The packaging line must be revalidated as
equipment is added to generate each bar code. • Ensuring that all serialization systems use
Each code must be linked to product data and common capabilities: product identifica-
applied to packages to enable tracking throughout tion equipment (PIE), product identification
the supply chain. And, last: middleware management systems (PIMMS) and
electronic product code information systems
• Change management: Employees must be
(EPCIS). All of these must be designed to
trained to handle the new equipment.
meet global standards and service all markets
Moreover, serialization demands that voluminous (“design once, use many”).
data repositories are shared at all nodes of the
pharmaceuticals supply chain. High data volumes, Our serialization solution addresses the
accuracy, security and data reliability all add to challenges at the shop floor and plant levels, and
the challenges of implementing serialization. connects to the enterprise level. Our solution
deploys units of unique identification (“serializa-
Serialization: Our View tion”) and creates associated unit-level electronic
We see product serialization as one of the top records that can be easily accessed via the Web or
priority activities for pharmaceuticals and smart phones in real time. Simple and ubiquitous
medical devices companies, as mandated by access to product IDs (or UIDs) and related data
regulatory agencies. provide a previously unavailable level of visibility
into the production, distribution and use of
Serialization Underpinnings
Strategy
Material
Flow
GTIN: Factory Distributor Re-Packer Wholesaler Pharmacy Patient
12345678901234
Ser No. Serialize Pack
123AFDG789TR Data Flow
Exp: 220912
Parent>Child Pack Data 2D Scanner
Batch: 103 F Association
Common Global 2D Data Matrix Common Equipment Few Operating Models from
Standards Solution a Single IT& Data Model
Solutions
Identify Use Apply Share Manage
GS1 ECC200
GS1 Identification Marchesini GS1-Compliant
Data Matrix
Keys & SEA Vision Information Application
Barcode
System
Ways of Working
Figure 3
cognizant 20-20 insights 3

4. Carton Labeling and Association Process Flow
EPCIS External
Machine Product Line Enterprise
Systems
Agencies
E-code Stock
Electronic Product on System
Code Information Systems Generation of Batch
E-codes for Product
PIMMS
Batch E-codes Text files per
Control
for Product Pack Level Manage Association Upload XML Files
Files to Stock
Product Identification
Middleware Management System
Control
Print and Apply Associate Cartons Associate Cartons Associate Bundles Associate Shippers
Carbon Code with Batch with Bundles with Shipper with Pallet
Cartoner Bundler Case Packer Palletizer
Figure 4
products or their components throughout the • Evaluating current systems and processes
supply chain (see Figure 4). for product serialization, by considering
multiple factors such as functionality, technical
Our Methodology and Offerings elements, interfacing and cost.
We advocate that pharmaceuticals companies
undertake an in-depth analysis of the current
• Facilitating discussions on the future state “to
be” for serialization and gathering high-level
scenario and consider multi-phase implementa- requirements.
tion of serialization (see Figure 5), which entails
the following steps:
Serialization Blueprinting: Approach and Deliverables
Solution Blueprinting
Information Process Mapping Requirement
Phases and Implementation
Gathering and Gap Definition
Roadmap
• Gather and review • Process and systems • Review the processes • In this phase, a
existing documenta- walk-through. with process solution architecture
Our Methodology for Pharmaceuticals Serialization
tion, work manuals.
• Interview/focus group owners and look for for serialization would
• Interaction with
stakeholders (various
meeting with key stake-
holders.
redundant activities,
unnecessary process
be developed taking
into consideration the
business functions
and IT stakeholders
• points and challenges.
Identify current pain
steps, role ambiguity,
bottlenecks, cycle
various dimensions
such as data
time, etc. management require-
together) in an envi-
sioning workshop. • Capture process
handoffs between • Detailed analysis ments, packaging line
• of the current docu- considerations, line
Activities
Identify weaknesses to uncover data
people and systems. and product-specific
management func-
mentation. • Identify process and tionality for packing, variations.
technology opportuni- warehouse and distri- • A global master
• Identify inputs the
and outputs of
ties for improvements. bution operations. blueprint template for
processes. • Our SMEs of require-
develop a product serialization
is developed.
• packaging lines for
Select processes and
high level
ments for the future • Present final deliver-
“to-be” in discussions able and sign-offs.
in-depth study.
with all stakeholders.
• Present final deliver-
able and sign-off.
• Program overview. • Process maps. • High-level • High-level solution
• Workshop themes. • Gap analysis document. requirements/
Key Outputs
architecture/blueprint
• Measures of success. • High-level require-
ments.
to-be state.
• Interfacing
document.
• Project implementa-
• Individual creation/
validation of as-is
requirements. tion roadmap.
processes.
Figure 5
cognizant 20-20 insights 4

5. Our Standard Framework
We have customized consulting, POC and 1 Serialization
implementation/post-implementation support offerings for
SAP AIE 7.x
serialization, ePedigree, track and trace, product recall and
GS1 compliance requirements for pharma companies.
2 Pedigree
External Third-party, e.g.,
Tracelink , rfExcel
Manage Manage
3 System Interfaces
SAP AIE/Other ERPs
GS1-Compliant GS1-Compliant
PIMMS-PIE, EPCIS-PIMMS,
Application EPCIS-External (including pedigree)
Application
4 Mobile Operations
TBD
• Functionality is not a key differentiator — all vendors
comply with the same international standard.
5 Reporting
• All major pharmaceuticals companies are moving
to the same SAP modules for their business process. SAP OER/SAP BI
Figure 6
• Providinga high-level solution architecture, Conclusion
requirements documentation and roadmap for
Threats to the integrity of the drug supply are
implementation (see Figure 6).
likely to intensify in coming years. According to
Implementation Maturity Model Peter Pitts, director of the Center for Medicine
for Serialization in the Public Interest, global drug counterfeiting
Figure 7 depicts a model that we believe will help is growing at 12% to 16% a year, and, in 2010,
in identifying an organization’s degree of maturity generated as much as $75 billion in worldwide
for a successful serialization implementation. revenues. “It is shocking to realize that in some
Ascending Serialization’s Learning Curve
Level 1 Level 2 Level 3 Level 4 Level 5
Projects are managed Projects are managed A centrally managed Central PMO with End-to-end PMO from
at an individual level at a unit level with PMO with well- active management blueprinting to global
Governance
PMO and
and the synergies are no centralized PMO. defined processes for site-specific rollout with proactive
not exploited. Projects Slightly consolidated, and solutions, from variations and scope planning, detailed change
are managed as a no consideration for blueprinting to variations with clear and risk management, best
discrete unit. variations. deployment across communication practices and continuous
locations. plan and change improvement included.
management.
Basic solution Configuration is Data and packaging Data management Adaptable, flexible
Configuration
Management
configuration set-up repeatable, but needs line configurations and line-specific configurable serialization
that lacks flexibility and detailed study and are well-defined and configurations are solution enabling support
adaptation. design modification to designed with elements captured at the of wide variety of packaging
the code base. that can be assembled planning stage and line functions.
and realigned to global templates are
quickly accommodate in place.
changing demands.
Solution deployment Solution can be Deployment plan is Deployment plans Global development
Deployment
is planned for only modified and installed well-defined with all support multiple playbook is in place and
the pilot line with no in similar packaging common site and serialization and the solution is readily
Rapid
replicable code base. lines, but not readily packaging-line-specific coding requirements installable, replicable and
repeatable and the serialization variations with manageable easily upgradable across
timelines are not with actionable timelines. packaging lines and
predictable. timelines. locations.
Figure 7
cognizant 20-20 insights 5

6. Quick Take
E-code Serialization for a Pharma Major
We helped in implementing serialization for a • Managing and monitoring the change
leading global pharmaceutical major. management plan.
Scenario • Managing IT risks and issues.
• Client wanted to implement e-code serialization • Providing regular status reports to IT
which uses common capabilities (PIE, PIMMS, management.
EPCIS) and is designed to meet global standards Benefits Attained
and service all markets.
• Track-and-trace products deployed from the
• A complete solution was required to address point of packaging to the pharmacy.
data management and packaging functions.
• Reduced the risk of counterfeit products being
Our Role dispensed.
• Ensuring client standards are met through • Expired products now detected automatically.
engaging appropriate architecture, EIS and
quality resources at the right time.
• Performs product recalls more effectively and
efficiently.
• Engaging with other teams to deliver project • Delivers the right product to the right patient.
requirements.
parts of the world, somewhere between 30% manufacturers can realize even greater benefits
and 50% of drugs to treat serious diseases are such as total supply chain visibility and reduced
actually counterfeit,” said Food and Drug Admin- product recalls, over and above what is required
istration commissioner Margaret Hamburg, by regulatory compliance.
who added that the problem “is growing every
day.”3 Meanwhile, Joe Ringwood, chief operating Making the right investments in the right
officer of Systech International, noted: “Phar- technology with the right business partner can
maceutical counterfeiting is a global problem only help the pharmaceuticals ecosystem —
that is growing rapidly.”4 As a result, serialization manufacturers, wholesalers, distributors and
has the potential to be a very efficient tool for pharmacies — alleviate and eventually eliminate
pharmaceuticals leaders in the fight against the threat of counterfeited drugs to patient safety
counterfeiting. and wellness. Successful serialization will be a key
differentiator and a clear competitive advantage
Managing the transformation is a crucial and for pharmaceuticals companies in the near term
essential part of the overall serialization imple- and over the long haul as drug counterfeiting is
mentation strategy. By choosing a reliable partner reduced to a distant memory.
and developing a diligent implementation plan,
cognizant 20-20 insights 6

7. Footnotes
1
GS1 is the international standards group whose healthcare component is working on pharmaceuticals
product tagging standards. The GS1 system of standards is the most widely used supply-chain standards
system in the world. It is composed of four key standards: barcodes (used to automatically identify items),
eCom — electronic business messaging standards allowing automatic electronic transmission of data,
global data synchronization standards (GDSN), which allow business partners to have consistent item data
in their systems at the same time and EPCglobal which uses RFID technology for real-time item tracking.
For more information: http://www.gs1.org/about/overview.
2
“Mass Serialization in the European Pharmaceuticals Market,” Frost & Sullivan, page 23.
www.frost.com/prod/servlet/cio/140658996
3
http://drugstorenews.com/article/counterfeit-threat-intensifies
4
http://www.contractpharma.com/issues/2012-03/view_features/packaging-serialization-update/
References
• World Health Organization, “Medicines: Counterfeit Medicines,” Fact sheet No. 275 (January 2010),
available at www.who.int/mediacentre/factsheets/fs275/en.
• Pharmaceuticals and Packaging News (PMP News), “Combating Counterfeits,” Sept. 9, 2011, available
at http://www.pmpnews.com/article/combating-counterfeits.
• Center of Medicines in the Public Interest, “Counterfeit Drugs and China NEW,” available at
http://www.cmpi.org/in-the-news/testimony/counterfeit-drugs-and-china-new.
• Pharmaceuticals and Packaging News (PMP News), “Best Practices in Serialization,” June 18, 2009,
available at http://www.pmpnews.com/article/best-practices-serialization.
• GS1 Healthcare Reference book 2011/2012: http://www.gs1.org/docs/healthcare/GS1_Healthcare_
Reference_Book_2011-2012.pdf.
• Life Science leader “The Long Road to Serialization and Track and Trace,” March 27, 2012, http://www.
lifescienceleader.com/magazine/current-issue-3/item/4083-long-road-to-usserialization-Track-and-trace.
• Life Science Leader “Planning Serialization for Pharmaceuticals Manufacturer”:
http://www.lifescienceleader.com/magazine/current-issue-3/item/4124-planning-serializationfor-
Pharmaceuticals-manufacturers.
• EFPIA “Coding and Identification of Products: Towards Safer Medicines Supply”:
http://www.efpia.eu/Content/Default.asp?PageID=566
Other Useful Links
• http://www.bluespherehealth.com/wordpress/?p=236
• http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2888553
• http://www.healthcarepackaging.com/archives/2012/02/fda_changes_to_drug_bar_code_r.php
• http://www.bluespherehealth.com/wordpress/?tag=serialization
• http://www.bluespherehealth.com/wordpress/?p=845
cognizant 20-20 insights 7

8. About the Authors
Aravindhan Ramakrishnan is a Senior Consultant within Cognizant Business Consulting. He has extensive
experience across life sciences, energy and consumer goods industries. As an operations and technology
expert Aravindhan has been working with clients to help them transform their businesses. He focuses
on strategy development and implementation, technology strategy, organization design, operational
excellence and innovation management. Prior to Cognizant, Aravindhan was employed by IBM’s Strategy
& Transformation Practice and by Honeywell. He holds a bachelor’s degree in engineering and an M.B.A.
Aravindhan can be reached at Aravindhan.Ramakrishnan@cognizant.com.
Ghazala Yasmin is a Consultant within Cognizant Business Consulting. She has over one year of experience
in management consulting and business development, and has supported projects across various
industries: life sciences, chemicals and consumer goods. She holds a bachelor’s degree in chemical engi-
neering and an M.B.A. from NITIE, Mumbai. Ghazala can be reached at Ghazala.Yasmin@cognizant.com.
About Cognizant
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