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

1. Merck KGaA
Darmstadt, Germany
Dr. Philipp Buehle
Digital innovation by raw material suppliers to support
drug manufacturers’ processes
Smart Labels

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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. “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. 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. 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. 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. 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. 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. 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. 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. Smart Labels
From Label to Scan Now
29 Webinar: Smart Labels - Digital innovation by raw material suppliers to support drug manufacturers’ processes

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. 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 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. • 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. 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. Thank You!