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

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Presentation on theme: "…. Serialization and Track and Trace Gaurav Banerjee March 20 th, 2014."— Presentation transcript:

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

2 : Sharp Packaging Services Sharp Packaging Services, a division of UDG Healthcare plc 2 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 : Sharp Packaging Services Outsourced Commercialisation Solutions Medical information & Pharmacovigilance Sales channel solutions Medical Communications Patient support Event Management Logistics services Logistics admin Information services Admin services & tech support Homecare/cold chain Packaging solutions Formulation services Serialisation services Clinical trials logistics Specialist healthcare and scientific products and services Outsourced sales and marketing Distribution and Engineering 3

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

5 : Sharp Packaging Services Sharp Commercial Capabilities 5 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 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

6 : Sharp Packaging 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 Sharp Serialization and Track & Trace Services 6

7 : Sharp Packaging Services 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 7

8 : Sharp Packaging Services Sharp Site Level Serialization Architecture 8

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

10 : Sharp Packaging Services Serialization Solution Deployment / Work Flow 10 Package Level Serialized 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 2 nd Qtr. 2014

11 : Sharp Packaging Services 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

12 : Sharp Packaging Services 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

13 : Sharp Packaging Services 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

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

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