1. Serialization and Track and Trace
Gaurav Banerjee
March 20th, 2014

2. Sharp Packaging Services, a division of UDG Healthcare plc
Overview
Provide international commercial & clinical packaging and supply chain services to the pharmaceutical industry
1,400 employees
All US facilities are fully
cGMP & FDA inspected
Facilities in
United States
Allentown, PA
Conshohocken, PA
Phoenixville, PA
Europe
Wales, UK
Belgium
The Netherlands

3. Outsourced Commercialisation Solutions
Medical information & Pharmacovigilance
Sales channel solutions
Medical Communications
Patient support
Event Management
Packaging solutions
Formulation services
Serialisation services
Clinical trials logistics
Logistics services
Logistics admin
Information services
Admin services & tech support
Homecare/cold chain
Specialist healthcare and scientific products and services
Outsourced sales and marketing
Distribution and Engineering

4. Sharp Packaging Services
Sharp Clinical Services UK
Sharp Clinical Services USA
Belgium
Netherlands
USA

5. Sharp Commercial Capabilities
Package Specialized Products
Solid oral dose (tablets and capsules)
Oral thin film
Liquids
Powders
Ointments
Stability packaging
Child resistance packaging
Contract Services
Blisters / Carded Blisters
Bottles
Pouches / Stick-packs
Vial labeling
Auto injector pen assembly
Syringe labeling & assembly
Contract Services
Kit Design
Medical device packaging
Compliance packages
Pouching oral dissolvable film & transdermal patches
Specialty package designs
Serialization & E-Pedigree services
Engineering services
Project management services
Cold storage
Specialty Distribution
Physician Sampling Program
Markets Served
Rx / GRx
Biotechnology
OTC
Clinical packaging

6. Sharp Serialization and Track & Trace Services
Project Management Services
Package and process scope definition
Serial number management services and data mapping
Data Carrier selection and line integration
2D barcodes, RFID Tags
Pre-serialized carton/tag aggregation services
API development for Provisioning and Notification (EPCIS interface)
Flexible Technology solutions that drive Commercial Value for Customer Brand
REMs solutions
Physician, patient and care giver training and counseling programs
Patient registries
Event based reporting, Operational Data Sharing
Data management and customer interface
Specialty distribution, cold chain distribution

7. Sharp Global Technology Solution Partners
Systech International – Serialized Product Tracking (SPT)™
Systech Guardian™, Systech Advisor™, Systech Sentri™
Systech Citadel ™ EPCIS Capabilities
TraceLink
Data sharing, supply chain visualization, serial number management, EPCIS exchange
ERP interface EPCIS capabilities
Covectra - AuthentiTrak™ , ControlTrak ™ Solutions
Saas and on-site system configuration/integration
ERP interface, EPCIS exchange
Serial number management services
Application development and “point of dispense” clinical applications
OCS
Printing devices
Vision systems and control
Local data management
MPS Associates
Technology Solutions, QAD certified Integration Partner
Supply Chain and operational data exchange with customers
QAD/Microsoft Dynamics (Navision)
ERP system, Warehouse Management, Inventory Management, Order to Cash Processes

8. Sharp Site Level Serialization Architecture

9. SPS Enterprise Level Serialization Architecture
Customer, Clinician, Regulatory Agency Specified EPCIS/ERP
Citadel
Allentown (USA)
Conshohocken (USA)
Hamont-Achel (Belgium)
Herenveen (Netherlands)

10. Serialization Solution Deployment / Work Flow
Systech Guardian server installed in Allentown Summer 2007
Initial serialization pilot trials run Fall 2007
First commercial project line built and validated June 2009
Second line built and validated, Summer 2010
Third line installed and validated, Fall 2012
Conshohocken Site Systech Guardian installed Spring 2013
First Conshohocken serialized blister line production start-up, August 2013
First Allentown serialized bottling line validated, October 2013
Serialized packaging lines in process for Belgium site, target 2nd Qtr. 2014
Package Level Serialized Work Flow

11. Sharp Serialization Compliance Strategy
Sharp Packaging Solutions is customer focused
Sharp intends to not only meet regulatory requirements but also provide value added services to help our customers enhance supply chain visibility
With over 70 lines at Sharp packaging facilities in the US & EU, we have to plan our conversion to serialization in phases over the next 3 years, based on demand & line usage
In the near future, interconnectivity between serialization systems will become key to supply network collaboration

12. Organizational Governance for Serialization
Sharp XPReS concept
Technical Services
ERP system analysis
EPCIS administration
Ongoing support & maintenance
Capital Appropriation
Relocation & re-validation of non-serialized items onto different packaging lines

13. Serialization Implementation Challenges
Customer awareness/preparation
EPCIS interface compatibility
An evolving “standard” for data exchange
EDI, serialized ASN, and customization
Computer Systems Validation
Resource allocation and prioritization
Building a “bench” of technical expertise

14. Sharp Packaging Solutions – Tech Services
Sharp Packaging Solutions -
Proprietary & Confidential