Portals 1 090527 SToP MPfletschinger

8/6/2019 Portals 1 090527 SToP MPfletschinger

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SToP Project in the Pharmaceutical Industry

Matthias Pfletschinger Global Program Manager SerializedProduct Tracking, Novartis Pharma AG

Zurich - May 27, 2009


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Agenda

Business Drivers & Regulatory Situation

What Track & Trace means in Practice

Business relevance of SToP

Contributions to SToP

SToP Results

Pharmaceutical Industry Outlook

SToP - 20 May 2009


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Pharmaceutical Industry BackgroundBusiness Context

In 2004 the U.S. FDA issued a white paper recommending theuse of RFID for serialization of sales packs

California government had mandated mass serialization andproduct tracking of all sales packs for prescription drugs

High pressure for compliance through deadline of Jan 2009

Driver: Anti-counterfeiting

Only evolving standards and technology solutions

Data carrier: RFID (HF vs. UHF gen2) or 2D Datamatrix Codes

Lack of proven solutions re. integration of serialization and tracking intopackaging lines, distribution processes and local and global IT systems

Lack of IT systems to handle serialized product data as well as other product

security features e.g. holograms

In general manufacturing and distribution processes ofpharmaceutical products are highly regulated and require minutedocumentation when installing any system

SToP - 20 May 2009


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Globally increasing Regulatory DiscussionMass Serialization and Product Tracking

Drivers for Implementation

Enhance Patient Safety

Raise barrier against counterfeits

Combat Reimbursement Fraud

Past: Lack of standardized Solutions

Italy 2005: local serialization solutionimplemented, tracking pending

California 2009: e-Pedigree Lawpostponed to 2015

Today: 1st Harmonized Requirements

Turkey 2009: 2D data matrix serialization,tracking Jun 2010.

France 2011: 2D data matrix coding

Regionally harmonized regulations are

drafted in U.S. and EU respectively Emerging markets mandating or drafting

regulations for mass serialization &product tracking: Brazil & China

?

?

SToP - 20 May 2009


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What it means in practice...Mass Serialization & Product Tracking

Lot#: S0023Exp: 29-01-2011

HumanReadableVariable Dataembossed orprinted on-line

SerializedProduct

Database

WholesalerIn-MarketDistribution

Lot#: S0023Exp: 29-01-2011GTIN: 086912923

Human Readable Variable Dataprinted on-line+ Global Trade Item Number GTIN

Variable Data+ Global Trade Code+ Serial number - unique perpack, bundle, shipping case,pallet

Packaging Site

Packaging Site Distribution Center

SalesUnit

Lot#: S0023Exp: 29-01-2011GTIN1: 086912923Serial#: W78AZ92

Lot#: S0023

Exp: 29-01-2011GTIN1: 086912923Serial#: W78AZ92

Lot#: S0023

Exp: 29-01-2011GTIN1: 086912923Serial#: W78AZ92

PurchaseOrder

FinishedGoods

On-line

Codingof Sales Units

Today

Mass

Serializationof Finished Goods

ProductTracking

up to Pharmacy

1

2

3

In addition, same dataencoded + verifiedonline

France Jan 2011

France Jan 2011

Turkey June 2009

Turkey June 2009

Business Impact

Pre-printed localTrade Code (by supplierof packaging material)

Turkey Jun 2010, California Jan 2015/ Jan 2016

Turkey Jun 2010, California Jan 2015/ Jan 2016

Ministryof Health

Pharmacy

SToP - 20 May 2009


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Packaging Line

Print

Barcode& text

verify

barcode& text

SAPT&T and

CodingPackaging

System

Sales packs(carton, bottle, etc)

Sales packsgo to Bundle

Bundles goto Shipping

case

Shipping cases

go to Pallet

Print

Barcode& text

verify

barcode& text

PrintBarcode

& text

verify

barcode& text

PrintBarcode

& text

verifybarcode

& text

MES

Serial nrand

Batch datafor printing

Serial nr hierarchyand

Completed batch data

SAP

MES

Packaging Lines: Upgrade requiredMass Serialization of all Packaging Hierarchies

FinishedGoodsto distributioncenter

Packaging material

PartiallyPackedProduct(Blisters,

Vials,Tubes,

etc.)

Packagingmaterial

PhysicalWorld

InformationWorld

PartiallyPackedProduct(Blisters,

Vials,Tubes, etc.)

...with Online Codingand Mass Serialization

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Distribution: New Processes requiredTracking product from Production Site to Wholesaler

International

LocalSupply Chain

Serialization Data

Shipment Data

Serialization Data

Central

Data

Repository

Customers(Wholesalers)

Ministry of Health

...with ProductTracking Data

SToP - 20 May 2009


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Pharmaceutical Industry BackgroundBusiness Drivers

Business motivation when joining SToP project in 2006 enable best-practice sharing regarding product security with academia,

aerospace, security printing and luxury goods, solution providers.

drive a fact-based selection of the most appropriate RFID technology forserializing pharmaceutical sales packs

support a business decision of RFID vs. Datamatrix serialization

explore the practical relevance of RFID vs. Datamatrix to the end-user(pharmacy trials)

ensure that future product verification systems would be suitable forpharmaceutical production and distribution

Share industrial experience of mass serialization in packagingand distribution of an industrial scale implementation that was

established independently of SToP

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SToP in the Pharmaceutical IndustryContributions

Active contribution through details regarding mechanisms of counterfeiting trade within the

Pharmaceutical Industry

identifying the most appropriate RFID technology for serializingpharmaceutical sales packs through laboratory trials - mimicking thepackaging process of pharmaceuticals

formulating the requirements for a Product Verification Infrastructure(PVI) intended for the Pharmaceutical Supply Chain whilst ensuring thatfuture systems are addressing all business needs

producing mass serialized placebo product (RFID tags & data matrixcodes) to test the PVI.

exploring the practical relevance of RFID & Datamatrix to the end-user

sharing best-practices with key interested stakeholders (EFPIA)

analyzing the ongoing industrial runs to drive a fact-based businessdecision of RFID vs. Datamatrix serialization

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Demo Video

Video showing the operational pilot of packaging serializedpharmaceutical products

SToP - 20 May 2009


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SToP in the Pharmaceutical IndustryKey Results

The STOP work helped to shape implementation strategy forunique serialization and product tracking of pharmaceuticalgoods an implementation program that will continue for thenext 10 years to come

STOP trials with end-users identified Issues regarding printquality of Datamatrix codes and artwork layout.

Technical requirements for future implementations were improved

Issues and corrective actions were communicated to other pharmaceuticalcompanies within the EFPIA (European Federation of Pharmaceutical Industriesand Associations).

STOP activities helped to adjust technical requirements for

Product Verification Infrastructures (PVI)

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Today

Pharmaceutical Industry OutlookCapability Roadmap

Basic Understanding of Serialized Packaging Feasibility Trials for Technology Selection & Integration

End-user Trials PVI Definition

Industrial Packaging Pilot Integration into packaging line - industrial conditions Compliance with regulations for 1st products Take business decision on data carrier = 2D Datamatrix1

Industrial Packaging Roll-out

Optimize packaging line integration Compliance with regulations for all products

Industrial Tracking Pilot Upgrade 1st Distribution Centers Compliance with 1st local regulations

Time

Industrial Tracking

Roll-outUpgrade all requiredDistribution Centers to achievecompliance

Capability

1

2

3

2006

4

5

2009 ~ 2015 tbd

1 Results to be published

SToP - 20 May 2009


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Thank you.Any Questions?

Matthias Pfletschinger

Global Program Manager Serialized Product TrackingNovartis Pharma AG


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Serialization of Pharmaceutical ProductsSToP Project Results

Scope: Tablets in Plastic Bottles

No liquids

No aluminum contained in packagingmaterial

Data Carrier

2D Datamatrix RFID UHF Gen 2 integrated into the bottle label

Rejected: RFID HF

Process: On-line encoding on packaging line at 250 packs p. min

Results

Operational since January 2008

~250000 Packs serialized

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Industrial Results of SerializedPharmaceutical Products

1. RF implementations are unique per

packaging line

Different dosage forms & packagingmaterials in pharmaceuticals requiredifferent RF frequencies (+ readers):aluminum, glass, liquids

Different installations of existing

hardware Unique situation regarding RF

interference & RF shielding

2. Managing RFID label quality is achallenge: Three suppliers contribute

to the final result Tag producer

Inlay producer

Label Converter

SToP - 20 May 2009


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Industrial Results of SerializedPharmaceutical Products - continued

3. Still unacceptable reject rate when producing serialized packs

Directly after go-live: 12% or equivalent to 30 packs per minute

After >20 lots: 2.2% or equivalent to 5 packs per minute

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Selection of Data CarriersGS1 2D Datamatrix Standard has emerged as standard forsales pack coding within the healthcare industry

RFID 2D Datamatrix Linear / StackedBarcode

AvailableStandards

LF Low Frequency

HF High Frequency

UHF Ultra High Frequency

GS1

ISO

GS1

Situation

Frequency bands notharmonized globally

No single solution availablethat covers all requirements(e.g. liquids, solids, metal)

GS1: Some minor detailsregarding hierarchybuilding still open

ISO: Focus on automotiveindustry

Technical disadvantagescompared to 2D (highspace requirements onpackaging material)

Adoption

Even within one marketmultiple standards are used

Limited outside U.S.

No legal requirement to date

GS1: required by law inTurkey, EFPIA, France,Spain, Serbia

GS1: regul. discussion:Germany, Italy, Brazil,California

Required by law in Japan,Belgium, Italy, S. Korea

Regulatory discussion:China

Conclusion

Currently too expensive

Performance requires furtherimprovements

Still hurdles to wide-spreadadoption

GS1 standard receivessupport by more & morelegislations

Solution of Choice

Line hardware for 2D isable to handle linear &stacked barcodes

Investment into 2Dcovers theserequirements as well

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End-user Trials in PharmacySToP Project Results

Approach: Use uniquely serialized pharmaceutical product for apoint of sale verification in two Pharmacies (2D Datamatrix Code& RFID UHF Gen2)

Results

1. Quality issues with reading of 2D datamatrix code Reason A: Low resolution of point of sale code

readers compared to industrial high-resolutioncameras

Recommendation A: Print quality of 2D codemust be increased on the packaging line Grade C or better as per ISO/IEC 15415.

Reason B: Barcode readers in the pharmacy

confused the pre-printed linear barcode andthe 2D datamatrix code as both codes werephysically close to each other.

Recommendation B: Do not place linear barcodes and 2D barcodesnext to each other on the packaging material

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End-user Trials in PharmacySToP Project Results - Continued

2. Pharmacy staff preferred RFID over 2D Datamatrix

Further tests are required to confirm readability for liquiddrug substances & product with metallic packagingcomponents.

3. SAP Prototype of the Product Verification Infrastructure (PVI)was able to manage data storage and point of sales

verification for multipleproduct security features.

SToP - 20 May 2009


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Product Verification IT SystemSToP Project Results

Business Issue: Enable fast verification of suspect samples inthe market based on multiple levels of product verificationfeatures, like...

Unique serial numbers per sales pack

e.g. Copy detection pattern

e.g. Holograms

...

With the Product Verification Infrastructure (PVI) theconsortium partner SAP demonstrated successfully thetechnical feasibility of such a system

Open question: Availability of standard IT system

SToP - 20 May 2009

Portals 1 090527 SToP MPfletschinger

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