Portals 1 090527 SToP MPfletschinger
Transcript of 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
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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
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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
?
?
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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
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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
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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
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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
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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
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2006
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2009 ~ 2015 tbd
1 Results to be published
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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
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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.
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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
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