Serialized track and trace. Is it a requirement you need to conform to or need?

A member of The Business Maturity Group

Solutions to Business Problems

Serialized track and trace. Is it a requirement you need to conform to or need

May 23rd, 2013

copyright © 2013 Q Data USA, Inc. All rights reserved. a member of The Business Maturity Group

Q Data SAP EM Webinar Series

May Theme: Solutions to Business Problems

Thursdays at 11am CST

1. How can you pay suppliers more promptly thus being eligible for

those terms discounts? (5/9)

2. How can you ensure that your sensitive products leaving your care are ultimately tracked and returned as expected? (5/16)

3. Serialized track and trace. Is it a requirement you need to conform to or need? (5/23)

4. Vendor Compliance, scorecards, EDI, Procure to Pay, ASN and Supply Chain Maturity! Scary or Logical? (5/30)

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Throughout this webinar

What is the weather like over there?


Agenda

Vocabulary

Standards

Components

Regulations

Wrap-Up and Questions


Chain of Custody (CoC)

It is a legal term that refers to the ability to

guarantee the identity and integrity of

the sample / product (and data) from the point of origin to the final destination…

A Definition


Chain of Custody (CoC)

What does it look like? THE PLAYERS…


Chain of Custody (CoC) – Part 1/3

How do we uniquely identify a product?


“A permanent unique mark on an object, designed to be scanned and interpreted digitally, identifying the object individually”

Unique Identification (UID)

When you can uniquely identify an item and exchange information about the item

in a standard format you can electronically track that item giving …

You improve data quality, inventory control, enable rapid fraud detection,

Provide visibility from cradle to grave, …


Item Unique Identification (IUID)

• Spawned by a DoD (2003) mandate for improved item management: •Is the most mature of all the UID initiatives

•Is currently the focus for SAP Solutions

•Is usually a 2-D barcode; it may be an RFID tag

Construct 1: Items that are

serialized within the enterprise

identifier

Enterprise ID + Serial #

Construct 2: Items that are

serialized within the part, Lot or

batch within the enterprise

Enterprise ID + Part # + Serial #

www.bpn.gov/IUID

In concert with RFID technology • IUID can provide the “what” • In addition to the RFID “where”


Electronic Product Code (EPC)

• provides a universal unique, serialized identifier for any kind of object

• GTIN (Global Trade Item Number)

• GRAI (Global Returnable Asset Identifier)

• SSCC (Serialized Shipping Container Code)

• GIAI (Global Individual Asset Identifier)

• SNI (Standardized Numerical Identifier) – FDA Pharma

• The EAN/UPC bar code, which encodes GTINs, provides identifying information for a class of item

• EPC goes beyond this when a GTIN is encoded in an EPC by identifying an individual serialized item or instance of the item (sGTIN).

• Two cases of the same product will have the same GTIN, but will have different EPCs (sGTIN).

The EPC structure is defined by the EPCglobal Tag Data Standard…

www.gs1.org/epcglobal

http://www.gs1.org/epcglobal


National Drug Code (NDC)

• Unique ID provided to permit automation of processing of drug data between government, drug manufacturers and distributors, hospitals and insurance companies

• 1972: Mandatory for all prescription and OTC drugs

• 2004: Mandatory linear barcodes on drug packages

• Contains: • FDA Labeler code, Product Code, Package size (10 digits)

An NDC…

“…provide an identification system in computer language to permit automated processing of drug data by Government agencies, drug manufacturers and distributors, hospitals, and insurance companies” (from 34 FR 11157, July 2, 1969).

http://www.rxtrace.com/wp-content/uploads/2010/03/img_fdagov_hp_logo_type.png


Global Trade Item Number (GTIN)

• an identifier for trade items by GS1 • comprising among others of the former EAN International and

Uniform Code Council (UCC)

• used to look up product information in a database

• GTINs may be 8, 12, 13 or 14 digits long

• Company Prefix, Item Reference and a calculated Check Digit GTIN-14 adds another component- the Indicator Digit, which can be 1-8

Global Trade Item Number (GTIN) is …


• Barcode: “Optical machine-readable representation of data, which shows data about the object to which it attaches.”

• 2-D Barcode

• Linear Barcode

Barcode


GTIN, UPC and EAN

GTIN-8s will be encoded in an EAN-8 bar code

GTIN-12s may be shown in UPC-A, ITF-14, or GS1-128 bar codes

GTIN-13s may be encoded in EAN-13, ITF-14 or GS1-128 bar codes

GTIN-14s may be encoded in ITF-14 or GS1-128 bar codes

• Universal Product Code

(UPC) dominant barcode standard in North America

encodes a 12 digit number (GTIN-12) which allows it to be scanned and read in almost any retail store

• The EAN-13 and EAN-8 are other point of sale barcodes that are widely used outside of North America.

A UPC can be transformed into an EAN by prefixing it with a zero


Data Matrix vs. QR Code – 2D

Data Matrix

• Developed in 1989

• 2,335 alphanumeric characters

• Considered more secure

• Cannot handle Japanese characters

• 22 x 22 (10 x 10, … 144 x 144)

• 17% recognition area

• More compact

QR (Quick Response)

• Developed in 1994

• 4,296 alphanumeric characters

• Accommodates Japanese characters

• 29 x 29 (21 x 21, … 177 x 177)

• 27% recognition area


• “… is a technology that incorporates the use of electromagnetic or electrostatic coupling in the radio frequency (RF) portion of the electromagnetic spectrum to uniquely identify an object, animal, or person.”

• Active Tag:

• Requires a battery, antenna, more expensive, great distances, larger, shorter life, cheaper readers

• Passive Tag:

• No battery, coiled antenna, less expensive, short distances, smaller, last longer, fixed readers

Radio Frequency Identification Technology (RFID)

RFID:


• Example applications of RFID: • Security access

• Item and asset management

• Ticketing and baggage tracking

• Toll collection

Radio Frequency Identification Technology (RFID) (cont.)

• Inventory RFID tags can be applied to:

Cases Pallets Items


UID Data Matrix (Item Level)

Radio Frequency Identification Technology (RFID) (cont.)

RFID tags that carry data can be attached to packages at multiple levels, including item packages, cases, and pallets. Unique Identifiers can be attached or directly marked on items using a data matrix to carry the UID data elements.

• Linking UID with RFID

RFID Tag (Pallet Level)

RFID Tag (Case Level)

RFID Tag (Item Package Level)


RFID vs. Barcode

RFID advantages vs. barcodes

Category RFID Barcode

Line-of-Sight Not required Required

Security More difficult to copy Easy to copy

Environment/ Ruggedness

More tolerant of humidity, water, …

Susceptible to environmental conditions

Sense/record/transmit Active/Passive No read/write capability

Distance Can be read at greater distances (up to 300 feet)

Needs to be much closer (less than 15 feet)

Read rate Can read tags much faster (40+ tags/sec)

Much slower, requires line of sight (1/2 sec to read)

Reusability Usually protected by an outer shell or imbedded in the product

Limited due to exposure to wear and tare (for line-of-sight reasons)

Expense Usually much more expensive

Cheaper to apply


Pedigree and ePedigree

• “A drug pedigree is a statement of origin that identifies each prior sale, purchase, or trade of a drug, including the date of those transactions and the names and addresses of all parties to them.”

• The U.S. Food and Drug Administration (FDA) in the 2006 Compliance Policy Guide for the Prescription Drug Marketing Act

• “An ePedigree is simply an electronic document which satisfies a pedigree requirement. The primary purpose of an ePedigree is to protect consumers from contaminated medicine or counterfeit drugs.”

Chain of Custody


Agenda

Vocabulary

Standards

Components

Regulations



Chain of Custody (CoC) – Part 2/3

How can we get all players to play nicely with each other?


Standards

• Pharma trading partners need to adopt several standards to address e-Pedigree

• SNI (Standardized Numerical Identifier)

• Moving towards adopting this standard for all drug packages as part of the e-pedigree law

FDA Standards

Pursuant to Business and Professions Code section 4034, the “unique identification number” established and applied to the smallest package or immediate container by the manufacturer or repackager shall conform to the Standardized Numerical Identifier (SNI) set forth in the Guidance for Industry published by the U.S. Food and Drug Administration (FDA) in March 2010, consisting of a serialized National Drug Code (NDC) identifier (or equivalent product identifier for dangerous drugs for which no NDC has been assigned) combined with a unique numeric or alphanumeric serial number that is no more than twenty (20) digits or characters in length.



Standards

• GLN (Global Location Number)

• Unique ID of locations and legal entities

• 13 digit numeric

• GTIN (Global Trade Item Number)

• Helps automate buying and selling

• 4 constructs – 8, 12, 13, 14

• Contains info on the Item itself

GS1 Standards




Standards

• EPCIS

• Enables sharing EPC data between disparate applications (across enterprises)

• GDSN (Global Data Synchronization Network)

• Not currently used in the US pharma supply chain

• Built around several GS1 standards including the GS1 Global Registry® and data pools

• Secure & continuous synchronization of data

• Changes in DB are immediately synched with all companies you do business with

GS1 Standards


Electronic Product Code Information Services (EPCIS)

• EPCglobal® is leading the development of industry-driven standards for the Electronic Product Code™ (EPC) to support the use of Radio Frequency Identification (RFID) in today's fast-moving, information rich, trading networks

• The goal of EPCIS is to enable disparate applications to leverage

Electronic Product Code (EPC) data via EPC-related data sharing, both within and across enterprises

• What information can be shared via EPCIS standards? • The What, Where, When, and Why of events occurring in any supply chain is

exchanged, safely and securely, via the EPCIS standard

• This is important business information, such the time, location, disposition, and business

EPCglobal®




Agenda

Vocabulary

Standards

Components

Regulations



Components

• Serialized product – CoC Part 1/3

• To be able to Track and Trace it

• IUID, sGTIN

• Tag / Marking – CoC Part 1/3

• Unique readable marking of the product

• Standards – CoC Part 2/3

• All partners talk the same language

• ECPIS

What do we need to look at in order to provide an e-Pedigree?


Components (Ctd.)

• Solution – CoC Part 3/3

• Reader / Scanner : RFID / Barcode

• Repository – Store the data : SAP AII / SAP OER

• Query mechanism – Read the data : SAP PI / OER

• Trust? – CoC Part 4/3!!!

• What you say is in the box is actually in the box

• Inference

What do we need to look at in order to provide an e-Pedigree?


SAP Solutions for Auto-ID and Item Serialization

Auto ID Infrastructure

Enables and manages Auto-ID-Enabled

Operational Processes integrated with ERP

at local/regional level and SAP OER

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Object Event Repository

Provides Enterprise level Event-driven

Traceability and Visibility Applications


SAP Solutions for Auto-ID and Item Serialization (cont.)

Auto-ID-Enabled Business Process

Automation

Item serialized Product, Part, Asset, and

Hierarchy Life Cycle Traceability

Auto-ID-Enabled Outbound Processing

Auto-ID Enabled Inbound Processing

RFID-Kanban

Returnable Transport Items

Extensible to other ERP document

integration

SAP AII SAP OER/EM

Product Tracking and Authentication

Returnable Transport Items

Linear barcode

2-D barcode

Passive/Active RFID

Sensor events: Conditions, temperature,

locations

GS1/ EPCglobal EPCIS – certified conformance to

EPCIS Standard as an EPCIS Repository

[Beyond this OER can be easily extended to

custom attributes, vocabularies, etc.]

GS1/EPCglobal Tag Data (TD) Standard

GS1/EPCglobal TD Translation Std.

US DOD Guide to Uniquely Identifying Items

Beyond this AII can be easily configured to

other unique ID schemes

Domain

Core Solution

Standard

Processes

and Beyond

AIDC Support

Standards

Support

Hardware Integration in to App Store the Data


Delivery

System integration services: Value generation with RFID Physics and device expertise

Partner SAP &

Partner

Readers Process integration

Cross-system traceability

SAP

OER

Edge Execution + Enterprise Applications

Read, write, and transmit data to systems

Manage multiple readers

Cleanse data

Operator workflow

Translate raw data to

business execution +

Decision support and

execute transactions

Enrich Object Event Management Data

Enable

Tracking and Tracing

Function

Device Management

SAP

ERP

Solution Landscape

SAP ITS mobile

Partner

Device

Mngt

Solution

SAP &

Partner

SAP &

Partner

SAP

Value Add Partners

Value Add Partners

SAP

AII

SAP

NW PI

Capture

Query


SAP Auto-ID Infrastructure (SAP AII) (cont.)

• Immediate • Verification

• Real-time Delivery and Shipment verification – Data verification at point of capture

• Anti-counterfeiting

• Product instance authentication

• Visibility

• Enterprise and Supply Chain wide

• Stretches to all Business Partners securely

• SAP ERP transaction automation following AII data capture

• More efficient shop-floor operation without line of site data capture through RFID sensing

• Intrinsic • Instance item life cycle tracking

• Business data information sharing based on granular levels (EPCIS)

• Events, business context, instance IDs, dispositions

• Single version of truth: State and history (pedigree)

• Web-service based standardized B2B data discovery (EPCIS compliant)

• Real-time business-contextualized event-based data captured

• Extending enterprise data to the capture of real-world raw events

• Unique IDs issued for the lifetime of the products and assets – enabled Pedigree

Business Value



• EPC/Serial number range management

• EPC hierarchy management

• ePedigree data provisioning

• Unique ID schemas

• EPC

• IUID

• Custom

• Delivery document integration

• Undo (Useful when you need to undo one event for an item that is part of a hierarchy)

• Generic document interface

• Master data management

• User interface • Mobile and Desktop

• EPC enriched ASN

• EPC capture notification

• Store and forward – Delta queue – Scalable

• Tag commissioning and management

Functionality



Translating raw Auto-ID events into business context

Auto-ID Raw Events Business Processes

Repository

Translation

Logic


SAP Object Event Repository (SAP OER)

• EPCIS-level enterprise level solution that

• Serves as the system of record spanning the life cycle of uniquely identified objects across distributed systems

• Allows object related search

• Provides UI & query mechanism for business partner collaboration

• Tracks life cycle & conditions relating processes, hierarchies, parts & assets

• Provides process monitoring, proactive alerting, reporting capabilities

• Integrates with

• SAP ERP for Business Process Tracking (procure-cash, delivery tracking, transportation, etc.)

• Auto-ID Infrastructure that pushes Auto-ID events into OER

• Third-party Auto-ID Edgeware systems can be integrated with the EPCIS standard event capture notification interface

Functional Domain


• Tracking of serialized items and hierarchies

• Where is this particular item?

• Tracking attributes and serialized item characteristics

• Batch #

• Expiration dates

• Authentication of IDs

• Valid hierarchy

• EPC

• EPC/Attribute combinations

• Data discovery services

• Business Docs, HU

• Product/part IDs

• Qualified events

• Attributes

SAP Object Event Repository (SAP OER) (cont.)

Capabilities



• Movements Across Locations

• Show shipping durations between different locations across the supply chain

• Movements at Location

• Show processing durations at a location

• Proof of Receipt

• Check if an object was received at any other subsequent location

• Supply Chain View

• As-Built Configuration View

• Life cycle “Current“ Configuration View

SAP NetWeaver BW Reports for OER


-

SAP OER stores

hierarchies between

objects along their

entire life cycle


Hierarchy Tracking


Agenda

Vocabulary

Standards

Components

Regulations



Regulations

• California

• part of the California Business & Professions Code

• When?

• 2015: 50 % manufacturer’s products

• 2016: 100% manufacturer’s products

• July 1 2016: Wholesalers and repackagers

• accept and forward products maintaining e-pedigree

• July 1 2017: Pharmacy and pharmacy warehouses

• accept and pass e-pedigrees

What is being forced in and by when?



Counterfeit Version of Avastin in U.S. Distribution

“Roche conducted laboratory tests that confirmed the counterfeit version of Avastin. Packages or vials may be counterfeit if they:

• are labeled with Roche as the manufacturer

• display batch numbers that start with B6010, B6011 or B86017

The only FDA-approved version of Avastin for use in the United States is marketed by Genentech (a member company of Roche). The FDA-approved version does not include the Roche logo on the packaging or vials. In addition, Genentech’s FDA-approved version of Avastin vials and packaging have a 6-digit numeric batch number and expiration dates in a 3-letter month and 4-digit year format (e.g., JAN 2014). Genentech’s Avastin products are safe and effective for their intended uses.

The 19 medical practices in the United States purchased unapproved cancer medicines and, potentially, the counterfeit Avastin, from…”

http://www.fda.gov/Drugs/DrugSafety/ucm291960.htm

Egypt Switzerland Netherlands UK US Pharmacy

(Where else did the product go?)

FDA: Statement Issued: Feb. 14, 2012



http://www.rxtrace.com/wp-content/uploads/2012/02/counterfeit-Avastin-400mg-packaging.jpg


Regulations

Describing how e-pedigree could help…

according to the California Pedigree Law, any supply chain participant must be able to

produce a full pedigree for any package of drugs in their possession at any time….


Not Allowed to manufacturer drug!

OR Drug already in

circulation!!!

1. Register product (Own Serial # or Copied)



Regulations





No info of serialized drug!

2. Check product 1. Skip registration



Regulations





No info of serialized drug!

3. Check product 1. Skip registration

2. Skip check



Regulations





Good to Dispense!

1. Registration 2. Check 3. Check 4. Check 5. Check 6. Check



Regulations

• Fully Centralized

• Single instance of track and trace repository

• Requires global cooperation / policing !!! Viable?

• Semi-Centralized

• Multiple central track and trace repositories

• China, Turkey, Italy, Brazil

• Fully Distributed / Decentralized

• Communicate with up/downstream partners - EPCIS

• Communicate with previous partners individually

• Different models per country / dependency!!! Viable ?

3 e-pedigree models under consideration


Agenda

Vocabulary

Standards

Components

Regulations



Summary

• What are the keys to being able to track your serialized products?

• UID, EPC global standards, labels, readers, events, application integration

• Understanding the discussion points around RFID and Bar-codes

• Advantages: Line of site, distance to read, expense, read/write

• Passive vs. Active

Some key points to take home…


Summary – CoC Part 1

Serialized product with tags / markings (Barcode / RFID Tags)



Readers / Scanners using Global Standards



Global Repository and Secure Query Mechanism


More Info

http://www.qdatausa.com/ Webinar series on Business Issues – May 2013

http://www.facebook.com/SAPEventManagement SAP EM Facebook Page

http://qdatausa.wordpress.com Blog for Q Data by Kevin Wilson

“SAP Event Management – SAP’s best kept secret” available at Amazon.com or Genie Press at http://www.geniepress.com/qdata

http://www.geniepress.com/books/sapem.htm


Questions???

Some of Q Data’s SAP EM related Clients

Kevin Wilson Principle SAP Solution Engineer

[email protected] www.qdatausa.com

Serialized track and trace. Is it a requirement you need to conform to or need?

Business

Transcript of Serialized track and trace. Is it a requirement you need to conform to or need?