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

….

www.sharpservices.com

Serialization and Track and TraceGaurav BanerjeeMarch 20th, 2014

www.sharpservices.com: Sharp Packaging Services

Sharp Packaging Services, a division of UDG Healthcare plc

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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


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

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www.sharpservices.com: Sharp Packaging Services4

Sharp Clinical Services UKSharp Clinical Services USA

BelgiumNetherlandsUSA

Sharp Packaging Services


Sharp Commercial Capabilities

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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


Project Management Services- Package and process scope definition

Serial number management services and data mappingData 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

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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


Sharp Site Level Serialization Architecture


SPS Enterprise Level Serialization Architecture

Citadel

Customer, Clinician, Regulatory Agency Specified EPCIS/ERP

Allentown (USA) Conshohocken (USA) Hamont-Achel (Belgium) Herenveen (Netherlands)

http://www.microsoft.com/nl-be/dynamics/default.aspx







Serialization Solution Deployment / Work Flow

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


Sharp Serialization Compliance Strategy

Sharp Packaging Solutions is customer focusedSharp intends to not only meet regulatory requirements but also provide value added services to help our customers enhance supply chain visibilityWith 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 usageIn the near future, interconnectivity between serialization systems will become key to supply network collaboration


Organizational Governance for Serialization

Sharp XPReS conceptTechnical ServicesERP system analysisEPCIS administrationOngoing support & maintenanceCapital AppropriationRelocation & re-validation of non-serialized items onto different packaging lines


Serialization Implementation Challenges

Customer awareness/preparationEPCIS interface compatibilityAn evolving “standard” for data exchangeEDI, serialized ASN, and customizationComputer Systems ValidationResource allocation and prioritizationBuilding a “bench” of technical expertise

14 www.sharpservices.com: Sharp Packaging Services

Sharp Packaging Solutions -Proprietary & Confidential

Sharp Packaging Solutions – Tech Services

[email protected]

mailto:[email protected]

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