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Merck KGaA
Darmstadt, Germany
Dr. Philipp Buehle
Digital innovation by raw material suppliers to support
drug manufacturer...
2 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes
The life s...
Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes3
Agenda
Barc...
Barcodes are everywhere in our daily lives
4 Webinar: Smart Labels - Digital innovation by raw material suppliers to suppo...
Smart Labels
Barcodes are everywhere in our daily lives
5 Webinar: Smart Labels - Digital innovation by raw material suppl...
Smart Labels
Barcodes in pharmaceutical processes?
Do you want to avoid manual,
time-consuming data
processing and sources...
Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes7
Agenda
Barc...
Barcode – History Review
1
9
7
3
Firstexperim
ents
started
at
D
rexel
University/Philadelphia
UPC-code
introduced
in
U.S.
...
Barcode Definition and Types
• More than 30 different 1D
barcodes types
• Most common ones:
• Code-128 mostly as
GS-128
• ...
Barcode Characteristics I
10 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufact...
Barcode Characteristics II
11 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufac...
Smart Labels
RFID vs. Data Matrix 2D Barcode
12 Webinar: Smart Labels - Digital innovation by raw material suppliers to su...
Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes13
Agenda
Bar...
U.S.-FDA
- National Drug Code (NDC) - 21 CFR 201.25: “Bar code label requirements”
•“NDC number in a linear bar code that ...
Goal of EU directive “Falsified Medicine Directive” (2011/62/EU)
•Preventing and managing risks posed by counterfeit/falsi...
Barcode-related regulations
Unique Device Identification (UDI) in the EU & U.S.-FDA
16 Webinar: Smart Labels - Digital inn...
Smart Labels
Barcode related regulations – UDI in the EU & FDA
17 Webinar: Smart Labels - Digital innovation by raw materi...
Smart Labels
Barcode related regulations – UDI in the EU & FDA
18 Webinar: Smart Labels - Digital innovation by raw materi...
Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes19
Agenda
Bar...
Smart Labels
Reed Solomon Error Correction
20 Webinar: Smart Labels - Digital innovation by raw material suppliers to supp...
“GS1 - The Global Language of Business”
•A worldwide not-for-profit organization located in over 100 countries.
 Originat...
Smart Labels
22 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ proces...
GTIN example for Catalog Number 1.02367.9029:
04027269077082
Smart Labels
Global Trade Item Number (GTIN) Structure: Compa...
Falsified Medicine
DMCs are used to clearly
identify medicinal products
Smart Labels
Give access to product data
and relat...
Smart Labels
Conclusion: Why a Data Matrix 2D Barcode incl. GS1?
Data
Matrix 2D
barcode
Global
Standard
One (GS1)
Error
co...
Smart Labels
Direct Data Transfer Into Customer Systems
not for use
0104027269077082111712001519123110A1236967240102367902...
Direct data transfer: SAP example
27 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug ...
Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes28
Agenda
Bar...
Smart Labels
From Label to Scan Now
29 Webinar: Smart Labels - Digital innovation by raw material suppliers to support dru...
Copy to clipboard for
easy data access
Smart Labels
From Scan Now to Product Data
30 Webinar: Smart Labels - Digital innov...
Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes31
Agenda
Bar...
32 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes
Smart Lab...
• Falsified Medicine and UDI regulations build regulatory framework for
2D Data Matrix Barcode
• GS1 Standard supports glo...
Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes34
How can ba...
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Smart Labels - Digital Innovation by Raw Material Suppliers to Support Drug Manufacturers’ Processes

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This webinar will highlight different barcode types, regulations and standards applied to 2D barcodes in the industry, as well as applications and advantages of 2D Data Matrix barcodes.

Digital technologies offer new opportunities to provide and exchange information between raw material suppliers and their customers. While accessing product-related data for different raw materials and devices is essential, it can be a cumbersome task in the pharmaceutical quality and production processes. Often, data processing is required at many steps and must be done manually, which is time consuming and a source for potential errors. 2D Data Matrix barcodes offer a seamless and robust solution for data management, internal processes and inventory management challenges.

In this webinar, you will learn:
• Overview of different barcode types
• Regulations and standards applied to 2D barcodes in the industry
• Applications and advantages of 2D Data Matrix barcodes

Published in: Healthcare

Smart Labels - Digital Innovation by Raw Material Suppliers to Support Drug Manufacturers’ Processes

  1. 1. Merck KGaA Darmstadt, Germany Dr. Philipp Buehle Digital innovation by raw material suppliers to support drug manufacturers’ processes Smart Labels
  2. 2. 2 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes The life science business of Merck KGaA, Darmstadt, Germany operates as MilliporeSigma in the U.S. and Canada.
  3. 3. Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes3 Agenda Barcode – Definition, types and background Regulations and standards applied to 2D barcodes in the industry Applications and advantages of 2D Data Matrix barcodes Company Example - Scan Now Page Summary Introduction
  4. 4. Barcodes are everywhere in our daily lives 4 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes Smart Labels
  5. 5. Smart Labels Barcodes are everywhere in our daily lives 5 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes • Easy and reliable data transfer – e.g. Laboratory samples • Control of processes – e.g. Board pass, luggage • Registration processes – e.g. Identifying a cow • Prevent permutation – e.g. Baby • Logistic processes – e.g. Parcel distribution
  6. 6. Smart Labels Barcodes in pharmaceutical processes? Do you want to avoid manual, time-consuming data processing and sources for potential errors? Is accessing product-related data for raw materials and devices a cumbersome task in your pharmaceutical production process? 6 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes
  7. 7. Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes7 Agenda Barcode – Definition, types and background Regulations and standards applied to 2D barcodes in the industry Applications and advantages of 2D Data Matrix barcodes Company Example - Scan Now Page Summary Introduction
  8. 8. Barcode – History Review 1 9 7 3 Firstexperim ents started at D rexel University/Philadelphia UPC-code introduced in U.S. 1st EAN -code introduced in Europe 1 9 4 9 1 9 7 41 9 7 6 1st barcodes scanned at W alm art 8 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes EAN Association as precursor ofG S starts 1 9 7 7 1st PD F417 code 1 9 9 3 1st D ata M atrix barcode First ISO barcode guidelines 1st Q R-code 1 9 9 1 1 9 8 9 1 9 9 4 2 0 1 7 O ur Sm art Labels project w as launched UD I becom es m andatory w ithin EU EU Regulation Falsified m edicine m andatory FD A-UD I for class I devices m andatory 2 0 2 0 s 2 0 2 0 2 0 1 9 Smart Labels
  9. 9. Barcode Definition and Types • More than 30 different 1D barcodes types • Most common ones: • Code-128 mostly as GS-128 • Universal Product Code (UPC-A) • European Article Number 13 (EAN-13) Linear or 1D Barcodes 1 EAN-13 UPC-A • Also more than 30 different 2D barcode types! • Stapled and Matrix types are the most important categories • Codablock (Types A, F, 256) • Portable Data File (PDF417) 2D Barcodes2 3 Stapled Codes PDF417 • Aztec-Code • Quick-Response-Code (QR-Code) • Data Matrix Code (DMC) 4 Matrix Codes DMC QRAztec Optically coded and machine readable data that can be 1-dimensional (1D) or 2-dimensional (2D) 9 (01)04027269077082 EAN-13 Codablock F
  10. 10. Barcode Characteristics I 10 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes • Limited length by reader (Full ASCII character set) • Used for shipping and packaging industries • Worldwide • Part of GS1 standard • Error correction by 2 characters • 13 digit code (numeric only) • Used for retail and grocery • Worldwide • Part of GS1 standard • Error Correction by final check digit • 12 digit code (numeric only) • Used for retail and grocery • USA, CAN, UK, AUS, NZ • Part of GS1 standard • Error correction by final check digit • 2725 ASCII or 5450 numeric characters • Healthcare sample management • EU • Not part of GS1 standard • Error Correction by check sum CodablockEAN-13 (01)04027269077082 UPC-A GS-128 - Error Correction
  11. 11. Barcode Characteristics II 11 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes • 1850 alphanumerical, 2725 numeric characters • Used for boarding passes, driving licenses • Worldwide • Not part of GS1 standard • Error Correction by Reed Solomon • 7089 numeric or 4296 ASCII characters • Used for mobile applications, marketing links, … • Worldwide • Part of GS1 standard • Error Correction by Reed Solomon • 3832 numeric, 3067 ASCII characters • Used for railroad ticketing • Worldwide • Not part of GS1 standard • Error Correction by Reed Solomon • 3116 numeric or 2335 ASCII characters • Used for UDI, drug products • Worldwide • Part of GS1 standard • Error Correction by Reed Solomon QR Codes Aztec Data Matrix PDF417 - Error Correction
  12. 12. Smart Labels RFID vs. Data Matrix 2D Barcode 12 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes Radio-Frequency Identification (RFID) Data Matrix barcode Costs per label unit 5-10 ct Only some ink Cost per scanning point 1000-5000 € 40-1000 € Data volume 10.000 bit and more 3116 numeric characters 2335 ASCII characters Security Re-writable RFID chips might be falsified Can not be changed after printing process Flexibility in chemical/ pharmaceutical industry - PE vs. metal packaging needs different RFID chips - Restricted in ex-zone areas - No restrictions of package material - Ex-zone scanners already available Scanning distance 1 to 3 m - no direct visibility needed Up to 21 m – direct visibility needed Scans per “shot” 40-200 1 per scan Standardization GS1 & ISO standards: Yes, but frequencies are not globally harmonized GS1 & ISO standards: Yes                
  13. 13. Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes13 Agenda Barcode – Definition, types and background Regulations and standards applied to 2D barcodes in the industry Applications and advantages of 2D Data Matrix barcodes Company Example - Scan Now Page Summary Introduction
  14. 14. U.S.-FDA - National Drug Code (NDC) - 21 CFR 201.25: “Bar code label requirements” •“NDC number in a linear bar code that meets EAN/Uniform Code Council (EAN.UCC) or Health Industry Business Communications Council (HIBCC) standards.” •Needed on drug product packages but not on API labels. - Drug Supply Chain Security Act (DSCSA) •Includes the 2D data matrix code as an option to secure the supply chain of a drug. Conclusion: So far U.S.-FDA requests no 2D barcodes for serialization of packages. Barcode-related regulations U.S.-FDA & EU regulations 14 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes
  15. 15. Goal of EU directive “Falsified Medicine Directive” (2011/62/EU) •Preventing and managing risks posed by counterfeit/falsified medicines EU requirements •Implementation plan EMA/785582/2014 rev.2 / June 29, 2017: • Deadline for existing products: February 19, 2019 •Implementation is done by a Data Matrix 2D barcode •NEW - Serialization of each package within the barcode Barcode-related regulations U.S.-FDA & EU regulations 15 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes
  16. 16. Barcode-related regulations Unique Device Identification (UDI) in the EU & U.S.-FDA 16 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes • EU: Improve safety of patients through better transparency and traceability • U.S.-FDA: Identify medical devices through distribution & use On high level EU and U.S.-FDA regulations are quite similar • EU: Medical devices (2017/745) and in IVDs (2017/746) • U.S.-FDA: 21 CFR 801 Subpart B • EU: Depending in product type and specific classes between 2023 and 2027. • U.S.-FDA: 2020 for Class I (latest) • Unique Device Identification of medical device products and in-vitro diagnostics (IVDs)
  17. 17. Smart Labels Barcode related regulations – UDI in the EU & FDA 17 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes • Device Identifier (DI) which identifies labeler and specific version or model of a device • e.g. Global Trade Item Number (GTIN) issued by GS1 • GS1 is an U.S.-FDA-accredited issuing agency • Production Identifier(s) (PI) • e.g. by lot number, batch or serial number and expiration or manufacture date • Data carrier (2D Data Matrix Barcode) • Human Readable Interpretation (1-to-1 illustration of the encoded data) • 2D Data Matrix barcode incl. GS1 standard
  18. 18. Smart Labels Barcode related regulations – UDI in the EU & FDA 18 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes • Provide device specific data (DI) and related key data Aside from some details, requirements are the same • U.S.-FDA database: GUDID (already active) • EU database for medical devices and IVDs: EUDAMED • Manufacturers, authorized representatives, importers and distributors must track information related to medicinal devices • U.S.-FDA & EU ask for a complete data traceability provided by a 2D Data Matrix barcode
  19. 19. Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes19 Agenda Barcode – Definition, types and background Regulations and standards applied to 2D barcodes in the industry Applications and advantages of 2D Data Matrix barcodes Company Example - Scan Now Page Summary Introduction
  20. 20. Smart Labels Reed Solomon Error Correction 20 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes • Consumer technologies: CDs, DVDs, Blu-ray Discs • Barcodes: PDF417, Aztec, QR, Data Matrix • DSL (Internet), DVB (Television), RAID 6 (Data storage) • Introduced in the 1960s by I. Reed and G. Solomon at MIT Lincoln Laboratory • 1st application during NASA Voyager program in 1977 • Non-binary cyclic error-correcting code • Can detect multiple symbol errors up to 30%
  21. 21. “GS1 - The Global Language of Business” •A worldwide not-for-profit organization located in over 100 countries.  Originated by fusion of EAN International (EU) and Uniform Code Council (U.S.). •Goal: Develop and maintain global standards as language for business communication. •They offer standards for: • Identification – by globally unique identification keys – e.g. Global Trade Item Number (GTIN) • Capture – Definitions for 1D & 2D barcodes and radio-frequency identification (RFID) data carriers by GS1 Application Identifiers (AI) • Share – Exchange of business-critical information – e.g. product master data • Use – Streamlining business processes – e.g. traceability  More than 20 GS1 standards in place. •Applications: • Retail industry is dominated by the GS1 system. • Within healthcare e.g. falsified medicine prevention. Smart Labels Global Standard One - GS1 21 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes
  22. 22. Smart Labels 22 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes 1 EAN & GTIN are global @GS1 registered unique trade numbers specific for each product package. 2 3 ! EAN is the older 13 digit version, e.g. used in 1D barcodes on our chemicals product labels. GTIN is the newer 14 digit number and is required for 2D Data Matrix barcodes following GS1. GTIN is mandatory for leading digital e-commerce platforms. Global Trade Item Number - GTIN
  23. 23. GTIN example for Catalog Number 1.02367.9029: 04027269077082 Smart Labels Global Trade Item Number (GTIN) Structure: Company Example 23 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes • GTIN tells you that it is a product from our company • Identification & verification of a specific product package Data Sections Content 0 Indicator digit converts a 13 digit EAN into a 14 digit GTIN without changing the check digit 2 4027269 GCP (Global Company prefix)  stands for our company 07708 7708th of 100.000 items which can be registered under one GCP 2 Check digit
  24. 24. Falsified Medicine DMCs are used to clearly identify medicinal products Smart Labels Give access to product data and related data UDI DMCs mark and identify medical devices within the healthcare supply chain Smart Labels The Data Matrix 2D barcode - One platform to improve processes FM UDI SL 24 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes
  25. 25. Smart Labels Conclusion: Why a Data Matrix 2D Barcode incl. GS1? Data Matrix 2D barcode Global Standard One (GS1) Error correction up to 30% Established in pharmaceutical industry • Defined by ISO/IEC 16022:2006 • Product data can be incorporated • Industry standard • Application Identifier Codes compatible to a broad range of electronic systems • ECC200 Reed- Solomon Error Correction is used • More robust against specular reflection or degradation of the barcode Authorities: •UDI regulations •Falsified medicine directive 25 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes25
  26. 26. Smart Labels Direct Data Transfer Into Customer Systems not for use 0104027269077082111712001519123110A12369672401023679029422276 GS1 Application Identifier Codes 01: Global Trade Item Number 11: Manufacturing Date 15: Expiration Date 10: Lot/Batch Number 240: Item Number 422: Country of Origin 26 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes Barcode data will remain human readable on labels
  27. 27. Direct data transfer: SAP example 27 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes 0104027269077082111712001519123110A12369672401023679029422276 Smart Labels Distribute data content directly into pre- defined fields within SAP by GS1 AIs
  28. 28. Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes28 Agenda Barcode – Definition, types and background Regulations and standards applied to 2D barcodes in the industry Applications and advantages of 2D Data Matrix barcodes Company Example - Scan Now Page Summary Introduction
  29. 29. Smart Labels From Label to Scan Now 29 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes
  30. 30. Copy to clipboard for easy data access Smart Labels From Scan Now to Product Data 30 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes
  31. 31. Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes31 Agenda Barcode – Definition, types and background Regulations and standards applied to 2D barcodes in the industry Applications and advantages of 2D Data Matrix barcodes Company Example - Scan Now Page Summary Introduction
  32. 32. 32 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes Smart Labels Summary – Smart Labels • For the entire Life Science portfolio • Data matrix 2D barcode type • GS1 as global standard • Product data within 2D barcode
  33. 33. • Falsified Medicine and UDI regulations build regulatory framework for 2D Data Matrix Barcode • GS1 Standard supports global use in various tools • Increased robustness through Reed Solomon error correction • Smart Labels provide standardized data access and data transfer Smart Labels Summary – 2D Data Matrix Barcode 33 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes
  34. 34. Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes34 How can barcodes help you to increase efficiency and reliability? Smart Labels  Convenient master data handling  More reliable data input into systems  Fast access to product documents  Verification of incoming goods and within supply chain processes
  35. 35. Thank You!

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