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

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

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

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?

• General Information on US Serialization Legislation

• GS1 Serialization Standards

• Artwork, barcodes and serialization data

• Serialization – The Process

• Master Data Architecture

Areas Covered

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

H.R. 3204 DRUG QUALITY AND SECURITY ACT.

US Serialization Legislation Overview

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

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.

GS1 SERIALIZATION STANDARDS

The language of Serialization.

What do you need to know? A high-level overview

• Useful general information

• Important concepts

• Some examples

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.

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.

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)

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)

• 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

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)

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

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

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

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.

Open discussion …

Do you speak GS1 now?

ARTWORK, BARCODES AND SERIALIZATION DATA

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

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

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 LOT EXP S/N

GTIN 00350242000000 SN 01234567890123 EXP DEC 2007 LOT 012345

Carton printing area width

Car

ton

pri

nti

ng

area

hei

ght

Zone for Print Instability ± x mm

Code + Quiet zone

Artwork Changes for Serialization Item / Unit Level

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

SERIALIZATION:THE PROCESS

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

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

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.

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

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

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?

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

• 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

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

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

Serialization Impact – Change Areas

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

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

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

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

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 !

Open discussion …

Are YOU Ready?

MASTER DATA ARCHITECTURE

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 System Line 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

• 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)

• Serialization Line Management Systems (SLMS) are directly integrated with Printing/Reading devices for real-time production monitoring, control, data collection and reporting.

SLMS

SSVR SLS

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

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

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

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

Attilio Bellman, Adept Packaging Practice Director,

Serialization & Technology

E-mail: attilio.bellman@adeptpackaging.com Mobile: +1 (347) 439-3587