Serialization and
Track and Trace
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Gaurav Banerjee
March 20th, 2014
www.sharpservices.com
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
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: Sharp Packaging Services
www.sharpservices.com
Outsourced Commercialisation Solutions
•Specialist healthcare
and scientific products
and services
•Outsourced sales and
marketing
•Distribution and
Engineering
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: Sharp Packaging Services
•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
www.sharpservices.com
Sharp Packaging Services
Sharp Clinical Services UK
Sharp Clinical Services USA
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: Sharp Packaging Services
Belgium
Netherlands
USA
www.sharpservices.com
Sharp Commercial Capabilities
Package Specialized Products
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Solid oral dose (tablets and capsules)
Oral thin film
Liquids
Powders
Ointments
Stability packaging
Child resistance packaging
Contract Services
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Blisters / Carded Blisters
Bottles
Pouches / Stick-packs
Vial labeling
Auto injector pen assembly
Syringe labeling & assembly
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Contract Services
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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
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Rx / GRx
Biotechnology
OTC
Clinical packaging
www.sharpservices.com
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
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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
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: Sharp Packaging Services
www.sharpservices.com
Sharp Global Technology Solution Partners
Systech International – Serialized Product Tracking (SPT)™
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Systech Guardian™, Systech Advisor™, Systech Sentri™
Systech Citadel ™ EPCIS Capabilities
TraceLink
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Data sharing, supply chain visualization, serial number management, EPCIS exchange
ERP interface EPCIS capabilities
Covectra - AuthentiTrak™ , ControlTrak ™ Solutions
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Saas and on-site system configuration/integration
ERP interface, EPCIS exchange
Serial number management services
Application development and “point of dispense” clinical applications
OCS
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Printing devices
Vision systems and control
Local data management
MPS Associates
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Technology Solutions, QAD certified Integration Partner
Supply Chain and operational data exchange with customers
QAD/Microsoft Dynamics (Navision)
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ERP system, Warehouse Management, Inventory Management, Order to Cash Processes
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www.sharpservices.com
Sharp Site Level Serialization Architecture
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www.sharpservices.com
SPS Enterprise Level Serialization Architecture
Customer, Clinician, Regulatory Agency Specified EPCIS/ERP
Citadel
Allentown (USA)
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Conshohocken (USA)
Hamont-Achel (Belgium)
Herenveen (Netherlands)
www.sharpservices.com
Serialization Solution Deployment / Work Flow
Systech Guardian server installed in Allentown Summer 2007
Package Level Serialized Work Flow
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
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: Sharp Packaging Services
www.sharpservices.com
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
11 : Sharp Packaging Services
www.sharpservices.com
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
12 : Sharp Packaging Services
www.sharpservices.com
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
13 : Sharp Packaging Services
www.sharpservices.com
Sharp Packaging Solutions – Tech Services
Gaurav.Banerjee@sharpservices.com
14 : Sharp Packaging Services
Sharp Packaging Solutions Proprietary & Confidential
www.sharpservices.com