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Serialization and Track and Trace

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Presentation on theme: "Serialization and Track and Trace"— Presentation transcript:

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

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