The document provides an introductory overview of serialization for manufacturers, distributors, and retailers in the pharmaceutical industry, covering key areas like GS1 serialization standards, the serialization process, and US legal requirements for implementing serialization at the unit level by 2017 and traceability at the package level by 2023. It also introduces the speaker, Dr. Attilio Bellman, who has over 16 years of experience in supply chain management and traceability.

1. UNDERSTAND
SERIALIZATION
A COMPREHENSIVE OVERVIEW FOR MANUFACTURERS,
DISTRIBUTORS AND RETAILERS
Dr. Attilio Bellman
Director, Serialization & Technology
Adept Packaging
November 4th, 2014

2. Focus of this presentation
This is an INTRODUCTORY training on serialization:
1. We fill focus on SERIALIZATION
2. We will focus on serialization for the pharmaceutical industry
3. We will focus on the US requirements for Serialization
4. We will give you the tools to actively participate in
conversations on serialization

3. Adept Packaging Practice Director, Serialization & Technology
• With Adept for 2 years bringing 16 years of experience in supply
chain management, and over 12 years in supply chain traceability,
item-level serialization, and supply chain security
• I am fully focused on serialization strategy and planning, serialization
solution design and serialization rollout for Pharma
Prior to joining Adept Packaging:
• Associate Principal, Serialization and Traceability Solutions, at Accenture
• Sr. Director Process Industry at Siemens IT Solutions and Services
• Subject Matter Expert positions at Siemens and Deloitte Consulting
• Master of Engineering in Logistics and Supply Chain Management from MIT (I started my work
on serialization in 2002 at the MIT/Auto-ID Laboratory)
• Master and PhD in Solid State Physics from University of Milan
Introducing Myself

4. INTRODUCTIONS
Let me know more about you:
1. Name
2. Company
3. Title
4. Are you familiar with GS1 standards?
5. Are you familiar with US serialization requirements?
6. Have you worked on any serialization-related projects?
7. What do you want to get out of this training?

5. • General Information on US Serialization Legislation
• GS1 Serialization Standards
• Artwork, barcodes and serialization data
• Serialization – The Process
• Master Data Architecture
Areas Covered

6. Many developing countries of Africa, parts of Asia, and parts of Latin America have
areas where more than 30% of the medicines on sale can be counterfeit. ~ WHO
International Medical Products Anti-Counterfeiting Task Force
Why are we talking about serialization?
Counterfeiting is a global issue in the pharmaceutical industry.
The World Health Organization (WHO) estimates that counterfeits constitute 10
percent of the world's drug market or about $32 billion in revenues. ~ Counterfeiting: A
Global Concern.” Pharmaceutical Executive. May 2005
Food and Drug Administration estimates the worldwide counterfeit pharmaceuticals
as a $35 billion industry. ~ Manufacturing. Net - December 28, 2006
Many of the former Soviet republics have a proportion of counterfeit medicines
which is above 20% of market value. ~ WHO International Medical Products Anti-
Counterfeiting Task Force

7. H.R. 3204 DRUG QUALITY AND
SECURITY ACT.
US Serialization Legislation Overview

8. Serialization – US Federal Law
• Signed into law on Nov 27th, 2013
• Law Highlights:
• The Federal Law Pre-empts California (and any other State laws)
• Nov 2017 – Unit level serialization for products sold in the US
• Nov 2023 – Unit level traceability (ePedigree, interoperable system across all
supply chain partners to exchange transaction)
H.R. 3204 Drug Quality and Security Act

9. INDIVIDUAL SALEABLE UNIT – The smallest container of product introduced into
commerce by the manufacturer or repackager that is intended by the manufacturer or
repackager for individual sale to a dispenser.
H.R. 3204 Drug Quality and Security Act
Some details from the Law
PRODUCT IDENTIFIER – A standardized graphic that includes, in both human readable
form and on a machine-readable data carrier that conforms to the standards developed
by a widely recognized international standards development organization, the
standardized numerical identifier, lot number, and expiration date of the product.
STANDARDIZED NUMERICAL IDENTIFIER – A set of numbers or characters used to
uniquely identify each package or homogenous case that is composed of the National
Drug Code that corresponds to the specific product (including the particular package
configuration) combined with a unique alphanumeric serial number of up to 20
characters.

10. GS1 SERIALIZATION STANDARDS
The language of Serialization.

11. What do you need to know?
A high-level overview
• Useful general information
• Important concepts
• Some examples

12. GS1 – A Global Unique Standard
Who is GS1?
GS1 Overview: http://www.gs1.org/
• GS1 is an global non-profit organization, dedicated to the design and
implementation of global standards and solutions to improve the efficiency and
visibility of supply and demand chains globally and across sectors.
GS1 Healthcare History in 3 Points:
• 1974 – The Uniform Code Council (UCC) is established in the U.S.
• 1977 – The European Article Numbering (EAN) Association is established as an
international not-for-profit standards organization.
• 2005 – The new name for the organization, GS1, is launched worldwide,
UCC, EAN and EPC are now GS1.
GS1 Healthcare US®: http://www.gs1us.org/healthcare
• GS1 Healthcare US is an industry group that focuses on driving the adoption and
implementation of GS1 Standards in the healthcare industry in the United States to
improve patient safety and supply chain efficiency.

13. GS1 Key offering for serialization:
• Standards for code typologies (GS1 Identification Keys).
• Standards for data carriers (Application Identifiers, GS1 Barcodes).
GS1 – A Global Unique Standard
GS1 Key Offerings
• Standardization is very important for serialization.
• A common set of standards will ensure interoperability and scalability of integrations.

14. GS1 Key Offering – Identification Keys
How to identify ‘things’
• The GS1 Application Identifiers (AIs) support the identification of information
within a GS1 barcode:
- Application Identifiers (AI) are used in barcodes to define data and
information type about products.
- Using this standard, barcode readers can identify data type and length.
• The GS1 Identification Keys (IKs) support the identification of items, services,
locations, logistic units, returnable containers, etc.
• In this training we will cover the main 2 Identification Keys used for serialization in
Pharma:
- GTIN: Global Trade Item Number (for item identification)
- SSCC: Serial Shipping Container Code (for container identification)

15. 1. The GS1 Key for unique product identification is the Global Trade Item Number
(GTIN). GTINs are used to identify “trade items”
2. They are assigned by the brand owner who is normally responsible for the
allocation of the GTIN
3. The GTIN is unique: The rules for assigning GTINs ensure that every variation of a
product (SKU) is allocated a single reference number that is globally unique
 LEARN – GTIN Application Identifier for Barcodes: AI (01)
GS1 Key Offering – GTIN
Global Trade Item Number (GTIN)

16. • For a specific product, the GTIN code is not enough to guarantee single items
uniqueness.
• GTIN + Serial Number (S/N) = sGTIN is the TRUE UNIQUE ITEM IDENTIFIER
(serialization!)
 LEARN – Serial Number Application Identifier for Barcodes: AI (21)
GS1 Key Offering – GTIN
Global Trade Item Number (GTIN)
SAME
GTIN
Unique Items
DIFFERENT
S/Ns

17. FDA Standardized Numerical Identifier
NDC – GTIN Link for the US Market
After 2007 FDA Amendments Act, a final standard has been released. FDA issued a
guideline identifying SNI (sNDC) or GS1 (GTIN) as univocal codes for selling units.
• sNDC is composed of the National Drug Code (NDC) that corresponds to the
specific drug product (including the particular package configuration) combined
with a unique serial number (S/N)
• GS1 provides a formula to embed the NDC into a GTIN-14 format (14 digits,
numeric) so problem solved for the US (you have an NDC -> you can derive your
GTIN)

18. LOT 123456 EXP DEC 1999 QTY 90
S/N 01234567890123
(17)160603(10)0002752(30)00035
(01)26568698084347(21)10000000001
AI Description Data Format
(01) GTIN 00000123000017
(10) LOT Number 123456
(17) EXP Date 991231 (December 31, 1999)
(21) Serial Number 01234567890123
(30) Quantity Each 090
Use of important “AIs” in a Barcode
EXERCISE – Identifying AIs in barcodes (Case Label)
123456 090

19. 1. The GS1 Key for unique “Logistic Units” is the Serial Shipping Container Code
(SSCC), for logistic units such as pallets.
2. The SSCC enables the unique identification of any combination of trade items
packaged together for storage and/or transport purposes (for example mixed
cases).
3. SSCCs are assigned by the brand owner. It contains the GS1 Company Prefix. A
globally unique number, assigned to each GS1 member company.
4. The SSCC is unique: Each SSCC has an embedded Serial Number
 LEARN – SSCC Application Identifier for Barcodes: AI (00)
GS1 Key Offering – SSCC-18
Serial Shipping Container Code (SSCC)
Example of a SSCC-18 structure :
(00) 003000401234567894

20. Example of a SSCC LABEL on a pallet:
Example 1: One SSCC
label placed on
oposite sides of the
pallet load
Example 2: SSCC
labels places on
adiacent sides of the
pallet
Pallet Serialization – SSCC-18
Serial Shipping Container Code (SSCC)
Serialized Shipping
container label for
pallet
SSCC-18
(00) 003000401234567894

21. AI Description Data Format
(01) GTIN Code 14 digits, numeric
(10) Batch or LOT Number 1 to 20 alphanumeric
(17) Expiration Date 6 digits: YYMMDD (“00” for DD if day not known)
(21) Serial Number Up to 20 alphanumeric
(30) Variable Count (Quantity Each) Up to 8 digits
(00) SSCC – Serialized Shipping Container
Code
18 digits, numeric
Application Identifiers Cheat Sheet
Most of what you need for serialization
• Application Identifiers (AI) are used in barcodes to define data and information
type about products.
• Using this standard, barcode readers can identify data type and length.

22. Open discussion …
Do you speak GS1 now?

23. ARTWORK, BARCODES AND
SERIALIZATION DATA

24. Encoded Data
Quiet Zone
Space on
each end of
the barcode
that tells
scanner
where the
code starts
or ends
Quiet Zone
(10 x smallest
Bar width, but
min. 6 mm)
Module
Represents data
bits
X-Dimension
Physical width of
smallest module
GS1 Linear Barcode – An Overview
GS1 – 128 Barcode

25. DATAMATRIX ECC 200 (by ISO/IEC 16022) is the code used for GS1 compliant
application for Pharma Serialization purposes.
Fixed pattern
(Handle) 1-module «L»
pattern of color representing
1. Used by camera to align
with symbol.
Fixed pattern
1-module wide pattern
alternating 1 and 0 symbols.
Used to sample modules
correctly.
Module (dot)
Represent data bits
X-dimension
Physical width of smallest
module (dot)
(different industry
standards require
different minimum sizes)
Encoded Data
Quiet zone
Space around
barcode that tells
scanner where
barcode starts and
ends. Al least 1x the
width of a module.
GS1 2D DataMatrix – An Overview

26. CODE – 2D DataMatrix
• Symbology: GS1 2D DataMatrix
• Encoded data Elements: AI(01) + AI(21) + AI(17) + AI(10)
e.g. 010035024200000021012345678901231707123110012345
• Minimum recommended
size 10mm x 10mm
• Define X Dimension (Density)
• Define Font for Human
Readable Text
GTIN LOTEXPS/N
GTIN 00350242000000
SN 01234567890123
EXP DEC 2007
LOT 012345
Carton printing area width
Cartonprinting
areaheight
Zone for Print
Instability
± x mm
Code + Quiet zone
Artwork Changes for Serialization
Item / Unit Level

27. LOT 1234567 EXP DEC 1999 QTY 090
S/N 01234567890123
(17)160603(10)0002752(30)00035
(01)26568698084347(21)10000000001
Artwork Changes for Serialization
Case Level
HDMA (Healthcare Distribution Management Association) recommends a specific
standard for the case label, containing the following information:
• 2D DataMatrix (OPTIONAL)
• 2 GS1 128 linear barcodes
• Encoded data Elements: AI(01) + AI(21) + AI(17) + AI(10) + AI(30)
GTIN S/N EXP LOT QTY

28. SERIALIZATION:THE PROCESS

29. Aggregation is the process of linking a set of small units (also
called CHILDREN) into a bigger one (PARENT), and create a
univocal parent-child correspondence between them.
Example: 3 unit serial numbers (CHILDREN) are aggregated
under the serial number of a case (PARENT)
• China for example, requires aggregation today. US, Europe
do not currently require aggregation by law. Korea and
Brazil are considering aggregation for the future.
Serialization Terminology
Aggregation

30. Serialization Terminology
De-Aggregation
It is also possible to de-aggregate children from a parent, for
example, by scanning single items via manual devices integrated
with the Serialization system.
Why de-aggregate?
• Retain and Samples for Quality Assurance reasons
• Creation of two partial cases to perform, for instance, two
different shipping

31. Encoding an item on a packaging line with a specific S/N is not enough to
define it as “univocally identified” in the supply chain. The S/N must be
verified and COMMISSIONED in the serialization system:
• The S/N must be inspected (i.e. a camera must be able to find a code
on its label and to correctly read it)
• The S/N must be unique (a system must confirm that the S/N was not
previously seen and used)
• The S/N status must be changed to Commissioned in the
serialization system
Serialization Terminology
Commissioning & De-Commissioning
All S/Ns that should not be introduced into the Supply Chain
(item rejected, QA samples, low printing quality etc.) must be
DECOMMISSIONED.

32. Each carton presents specific information, as GTIN code, LOT number, EXP date (these
can be common to other cartons of the same batch), and S/N (univocal for each single
unit).
GTIN 26568698084347
SN 00000000001
EXP DEC 2003
LOT 2752
GTIN 26568698084347
SN 00000000003
EXP DEC 2003
LOT 2752
GTIN 26568698084347
SN 00000000002
EXP DEC 2003
LOT 2752
Item (Bottles or Cartons) Serialization
Example – Carton Printing

33. One option is to aggregate cartons to a
case layer by layer:
• The cameras are mounted on a
pushing plate
• Cameras acquire the information from
the cartons labels all together when
the units are placed into the case-
loading hopper
• NOTE: This system require that the
S/Ns must be placed on the side of the
cartons.
BACK VIEW
FRONT VIEW
Item to Case Aggregation
Example – Carton Aggregation Layer by Layer

34. There are two types of equipment necessary to physically place
serial numbers on the package and then verify accuracy:
• Printing equipment. This includes ink-jet, laser, or other
technologies to mark directly on the package or label web to
apply the serial number and 2D/1D barcode.
• Vision Inspection systems: Inspect the package print/label
and code to verify the marking is legible and correct.
Serialization Hardware
Do you need new equipment?

35. HDMA (Healthcare Distribution Management Association) recommends a specific standard for
the case label, containing the following information:
• GTIN code, LOT number, EXP date, case quantity and S/N (univocal for each single case unit).
• The 2D DataMatrix is OPTIONAL.
LOT 2752 EXP JUN 2016 QTY 035
S/N 10000000001
(17)160603(10)0002752(30)00035
(01)26568698084347(21)10000000001
LOT 2752 EXP JUN 2016 QTY 035
S/N 10000000002
(17)160603(10)0002752(30)00035
(01)26568698084347(21)10000000002
Item to Case Aggregation
Example – Case Label Printing

36. • Cartons are commissioned and then aggregated to a case (parent-child relationship
is built).
• Cases are commissioned and aggregated onto a pallet (parent-child relationship).
• The aggregation data is stored in the serialization system.
Item to Case to Pallet Aggregation
Carton Example

37. Let’s discuss what needs to be done to implement serialization:
1. Serialization Assessment
2. Project RESOURCES
3. Artwork changes
4. SKU Rollout Plan & Timeline
5. CMOs / CPOs Rollout Plan & Timeline
6. Distribution Rollout Plan & Timeline
7. Last but not Least: PROGRAM MANAGEMENT
Serialization TO DO List

38. Serialization requirements will impact artwork (bottle/carton, case, pallet):
Need to add new data:
• GTIN
• S/N
• 2D Data Matrix
• Exp. Date and LOT
Serialization assessment areas:
Artwork Assessment:
• Available printing area
• Pre-printed vs. print in-line
Line Assessment:
• Printers, cameras, number of lines affected
Components Assessment:
• Need for different components, impact to suppliers
Serialization Assessment

39. Serialization Impact – Change Areas

40. It is necessary to plan for the serialization implementation at internal sites.
Develop a plan:
1. Analyze Country Requirements (and DATES!) and identify impacted SKUs
2. Develop a global SKU rollout plan
3. Identify impacted packaging lines
4. Develop a global line rollout plan
5. Identify impacted packaging plants and develop a global plant rollout plan
SKU Rollout Plan & Timeline

41. If you work with Contract Manufacturers (CMOs) / Contract Packagers (CPOs), you
have to plan for serialization at third parties:
Develop a plan (CMO/CPO alignment):
1. Identify impacted CMOs/CPOs and develop a global plant rollout plan
2. Governance: What is the CMO / CPO responsibility? Who does what?
3. Contract agreements: Embed serialization requirements into contracts
4. Timeline alignment: Will your CMOs/CPOs be ready when you need them to be?
5. CMO/CPO Risk Assessments: How do you define CMO/CPO risk?
6. Develop Requirement Documents to give to your CMOs/CPOs
7. Analyze country requirements (and DATES!) and identify impacted SKUs at CMOs
- Develop a global SKU rollout plan
- Identify impacted packaging lines
- Develop a global line rollout plan
CMOs / CPOs Rollout Plan & Timeline

42. The readiness of your Warehouses and Distribution Centers to handle and distribute
serialized products is just as important as the readiness of your packaging lines.
Develop a plan (DC alignment):
1. Identify impacted Warehouses / DCs and develop a global plant rollout plan
2. Governance: What is the Warehouses / DCs responsibility for serialization?
3. Contract agreements (for third party DCs): Embed serialization requirements into
contracts
4. Timeline alignment: Will your DCs be ready when you need them to be?
5. Develop Requirement Documents to give to your DCs
Distribution Rollout Plan & Timeline

43. Serialization impact analysis, SKU planning, CMO alignment are only some of the
necessary activities to manage a Serialization Program:
1. Secure program RESOURCES (internal, external)
2. Alignment and management of all sites, CMOs/CPOs, DCs, third parties
3. Vendor selection for serialization
4. Development of Global and Standardized User Requirement Specifications (URSs)
5. Development of Global and Standardized User Design Specifications (DSs)
6. Development of SOPs for packaging and distribution
7. Training of resources:
- Line operators and personnel
- DC and warehouse personnel
- IT personnel
- Customer service
- And many more …
Program Management

44. There are established Best Practices that you should follow:
1. Establish a Program Management Team: Serialization is a Program, not a Project
2. Assign Project Manager(s) to each work-stream
3. Engage your sites and establish serialization teams at each site (PM, line experts,
engineers, IT)
4. Engage your CMOs: Assign this responsibility to specific resource(s)
5. Engage your Distribution Centers
6. Establish an overall Training Program and COMMUNICATION program
7. Establish a Center of Excellence:
- Serialization software & hardware expertise
- Serialization process & requirements expertise
- And many more …
Program Management – Best Practices
Remember: It will be MORE
WORK than you thought !

45. Open discussion …
Are YOU Ready?

46. MASTER DATA ARCHITECTURE

47. To include all the functionalities required for serialization, it is necessary to add
specific components to each single level of a company existing IT structure.
ERP Serialization Modules
Global Corporation
(HR, Finance, Distr.)
MES, Manufacturing,
WMS
Serialization Server
Site Plant
(Manfacturing)
Line Management Systems
(SCADA/PLC)
Serialization Line
Management System
Shop Floor
(Line Management)
Machine Controller Serialization Line SystemLine Equipment
IT Architecture Level Serialization Component
LEVEL 4
LEVEL 3
LEVEL 2
LEVEL 1
Functionality Level
A Multi-Level Architecture
Serialization Impact to IT & Systems

48. • Serialization Servers (SSVR) enable enterprise-wide
visibility of packaging line data.
Serialization Site Server (SSVR) Functionality:
1. Receive serial numbers from ERP (SAP AII)
2. Store serial numbers for connectivity
3. Provide unique item-level serial numbers to
packaging units
4. Manage Level 2 Serialization Line Management
Systems (SLMS)
SSVR
Level 4
Serialization
Module
Database
SLS
SLS
SLS
SLMS
SLMS
SLMS
Level 3 – Site Plant
Serialization Server (SSVR)

49. • Serialization Line Management Systems (SLMS) are directly integrated
with Printing/Reading devices for real-time production monitoring,
control, data collection and reporting.
SLMS
SSVRSLS
SLS
Level 4
Serialization
Module
Database
Level 2 – Shop Floor (Line Specific)
Serialization Server (SSVR)
Serialization Line Management System (SLMS)
Functionality:
1. Conduct the line management activity for
serialization
2. Manage serialization product recipes
3. S/N buffers configuration (to allow line
serialization even when connectivity with site
server is down)
4. Manage the item to case to pallet aggregation
process on the packaging line

50. Packaging line
serialization
solution
Warehouse
serialization
solution
Level 4
Serialization
Module
Level 4
Serialization
Module
Level 4
Serialization
Module
DATABASE
ERP
Partners
integration
(CMOs)
Partner 1
Partner 2
Partner k
LEVEL 4
Serialization Data Flow
Serialization Impact to IT & Systems

51. Product setup
• Product serialization will require specific additional setup in existing IT systems (ERP)
and new Serialization IT Systems
Master Data setup in ERP (if integrated)
• The product must exist in the ERP system.
• A GTIN must be created for the product at the unit, (bundle) and case level.
• A Company Prefix for SSCC must be created for partial cases and pallets.
Serialization Data Repository setup
• Serialization Data for long term storage on enterprise level system
• Track & Trace Database with / without event and location feeds from Supply Chain
partners
• Cloud based Repository with interfaces to external partners and 3rd party organizations
Serialization System Setup
Enterprise Configuration

52. Track and Trace
Serialization in pharma started to enable the implementation of product Track and
Trace, improve supply chain security and reduce anti-counterfeiting.
Serialization Data will, not only, allow to perform tracking and tracing, but also, they
will provide detailed, real-time data to support and improve existing business
processes allowing better reporting and better process control.
Serialization Data can be used for different business purposes such as:
• Supply chain visibility (real time)
• Product Identification, Production Control
• Production Fulfillment
• Product Tracking, Anti Counterfeiting
• Supply Chain Monitoring
• Diversion Avoidance
• Recall Control, Reporting or Loss Investigations.
Master Data Management
Benefits from Serialization Data

53. Attilio Bellman,
Adept Packaging Practice Director,
Serialization & Technology
E-mail: attilio.bellman@adeptpackaging.com
Mobile: +1 (347) 439-3587