The document discusses serialization requirements being implemented globally to combat counterfeiting of pharmaceutical products. It provides an overview of regulations and timelines for serialization in various countries and regions. The benefits of serialization are described as combating counterfeits, optimizing supply chain operations, protecting brand value, and improving sales planning. The document emphasizes that manufacturers should take a 360 degree approach to serialization implementation and addresses how it affects all aspects of production, packaging, and distribution.

1. mind your own business
SERIALIZATION
GET ON THE
RIGHT TRACK
2013

2. Getonthe
righttrack
2
prepare
for combat
In an effort to combat counterfeiting, regulatory
bodies all over the world are introducing new
requirements for enabling tracking and authenti-
cation of pharma and biotech products. Primarily
aimed at codification, serialization (internal and
external tracking) and e-Pedigree (external track-
ing), the new requirements will have major impli-
cations for manufacturers, distributors and retail-
ers alike.
In many countries, such legislation has already
been put into effect and by the end of 2013, the
European Medicine Agency (EMA) will introduce
serialization legislation, to which all life science
businesses must comply by 2017.
Get on the right track – and start preparing for
combat today.
A Blessing in disguise
Few will question that serialization requirements serve a greater good: Combatting coun-
terfeit is in every pharmaceutical company’s interest - for ethical and economic reasons.
However, the imposement of yet another set of mandatory rules - and a short deadline for
achieving compliance - is also costly and resource demanding and makes pharmaceutical
manufacturing even more complex. Even though compliance is of course a goal in itself, it’s
money and efforts well spent to implement serialization – and it is for a number of other
reasons:
Combat counterfeit
The chief advantage of applying serialization
measures is also the fundamental driver behind
the legislation: It combats counterfeit.
According to the World Health Organization
(WHO), counterfeit drugs account for 7-15 per-
cent of all the medicines circulating in developed
countries – and up to 25 percent in developing
countries. It threatens the health and safety of
the consumers, weakens national economies,
emboldens criminal organizations and erode the
respect for intellectual proporty rights.
When genuine products become more identifi-
able, so do the fake ones. Counterfeit drugs are
easily stopped at the point of sale, and when
there are no money to be earned, the counter-
feit business will become less and less attractive.
The results are undeniable: Billions of lives are
saved and companies avoid counterfeit-related
economic losses.
Optimization of supply chain
Applying serialization technology and proce-
dures will bring major business benefits, based
on providing more accurate and timely track and
trace information across the entire supply chain,
including:
• Improved demand, production and distribu-
tion planning based on better understand-
ing of supply chain dynamics across distribu-
tion channels and markets
• Improved inventory control across internal
and external warehouses
• Improved shell life management, reducing
scrap
• Improved and more cost effective recall
management across the entire supply chain
Protection of brand value
and integrity
If your product is subject to counterfeit, your
company’s image may be compromised.
Anti-counterfeiting becomes an ethical dif-
ferentiator, as consumers expect companies to
take responsibility for combatting fake drugs.
Protection of your commercial product by means
of anti-counterfeit thus also protects your brand
value.
Improvement of sales planning
and forecast
An effective serialization system can improve
your ability to predict sales developments and
make more precise sales forecasts. The serializa-
tion system, in parallel to it’s prime purpose, can
also work as a “early warning system” that can
help you optimize e.g. sales campaigns.
Getonthe
righttrack
3
an End-to-End
Serialization solution
NNE Pharmaplan and NNIT have joined forces to
offer consulting and engineering services cover-
ing all aspects of serialization, from packaging to
the point of dispense.
Together we will take turnkey responsibility for
your serialization project, and we will stay at
your packaging site until the serialization solution
works perfectly and you have reached your OEE
target.
Both NNIT and NNE Pharmaplan have an insid-
ers’ understanding of pharma and biotech pro-
duction and are highly experienced in working
with large complex systems such as SAP object
event repository (OER) as well as other SAP
modules supporting the supply chain. We can
run projects from consulting through implemen-
tation to on-going support, leveraging proven
methodologies and adhering to superior quality
standards.
We work based on a proven model which
provides an effective method for structuring a
serialization project with minimal business risk
for the customer.

3. Emerging legislation
Established legislation
Getonthe
righttrack
4 Getonthe
righttrack
5
serialization
landscape
The concept of serialization is the same globally, but the scope
and status of requirements differ from region to region.
south korea
Background: Ministry of Health and Welfare
notification 2011 – 58.
Timeline: January 2013
Timeline aggregation: January 2015
Technology: GS1 standard. Data matrix and linear
code GS1-128
Based on:
Unit level: KD code
Sales level: KD code, Exp and Lot
Shipping level: Aggregation
Data scope: KD code (sGTIN), expiry date, lot num-
ber, S/N and SSCC codes are mentioned
China
Background: SFDA, April 9, 2008. Mandatory for
275 EDL (Essential Drug List) therapeutic
classes.
Timeline: December 2012
EDL expanded with +800 classes by
2015
Letter from the SFDA Department of
Drug Safety Supervision will be issued
with a two week response period and six
months implementation period.
Technology: Special 128c code
Based on: Chinese developed authentication code.
PIATS (Product Identification,
Authentication and Tracking System
Sales level: Yes
Shipping level: Yes, aggregation needed
Data scope: CNMC (China National Medical Code),
S/N and encryption code
miscellanous
Algeria: No regulations, no drafts but authorities are very
positive about the EU model
Belgium: Sequential stickers
US: DOD (Dept. of Defense)
RFID, Track Trace, inventory management in focus
France: Vignette stickers and CIP13
Egypt: No regulations, no drafts but authorities are very
positive about the EU model
Greece: EOF (National Organization for Medicines authenti-
cation stickers
Germany: Pilot in Q1 2013, national law
Italy: Bollini authentication stickers. Drift towards replace-
ment with 2D.
Spain: 2006, Article 87 exist but the Royal Decree
is still in draft. Code PDF 417. RFID considered
Japan: Special rules for special drugs regarding static
and dynamic data in code format. No S/N however.
Serbia: Stickers solution has been postponed
Russia: No regulations, no drafts but authorities are very
positive about the EU model
eu
Background: July 1, 2011 of the EU Falsified
Medicines Directive (FMD) implemented
throughout 2014 – 2017.
Each member state to plan minimum
requirements. Each member state can
act earlier when readiness has been
established.
Each member state can add
requirements (blue box principle)
Technology: GS1 data matrix / EAN-13
Based on: GS1 standards
Item level: GTIN (minimum)
Sales level: GTIN (minimum)
Data scope: GTIN-14, lot number, expiry date and
S/N was part of prior version of tender
demands but has been taken out
“technical guidance regarding Identifica-
tion key, May 17, 2011, version 2
India
Background: Directorate General of Foreign Trade
DGFT PUBLIC NOTICE No.21/(RE
2010)/2009-14, October 1, 2011.
Export pharmaceuticals only.
Likely to be expanded to import also
but no deadline. Delays and lawsuits
are rumbling.
Will hit low cost generics manufactured
in India hard.
Technology: GS1 2D data matrix or GS1-128 1D
linear
Based on:
Unit level: GTIN, Lot, Exp and S/N, January 2013
Sales level: GTIN, Lot, Exp and S/N, January 2013
Shipping level: GTIN, Lot, Exp and S/N, July 2012
Data scope: GTIN, Lot, Exp and S/N on all levels
Track Trace mandatory
turkey
Background: Phase 1, 2009: Mass serialization
Phase 2, 2011: Full aggregation
Original purpose to stop
reimbursement fraud and taxation
avoidance
Technology: GS1 data matrix or GS1-128 linear
Based on:
Unit level: No
Sales level: GTIN, Exp, Lot and S/N
Shipping level: Yes. Aggregation needed
Data scope: GTIN, Exp, Lot, S/N and SSCC
Database owned by Turkish health
authorities.
Africa
Background: Counterfeit products on the African
continent.
Tender and purchasing requirements
stated trough relief organizations and
agenesis (WHO, MSF, Red Cross/
Crescent and similar). Used since 2005/07
with very positive result.
Expanded use to be anticipated.
Technology: Simple numerical SMS code
Can be supplemented by AIDC’s
(Automatic identification and data
capture)
Hidden (tamper proofed) by means of
Multilayer or “Scratch Lottery Ticket”
Based on: Unique numbers
Readable for humans
Data scope: A serial number for verification by SMS
brazil
Background: ANVISA, Brazil law N° 11.903
Timeline: January 2012
Since “Special Security” label have
been abandoned, there has been a drift
towards the Turkish model.
Technology: GS1 data matrix. Tamper evident
(label / hot melt)
Based on:
Unit level: No
Sales level: GS1 data matrix
Shipping level: Tracking likely to be implemented
according to Turkish model
Data scope: GTIN, IUM (Unique Identifier for Medi-
cines), drug registration number, product
lot number, expiration date
argentina
Background: ANMAT Official Bulletin #32.160,
regulation 3683/2011. Resolution
435/2011
Timeline: June 15, 2011 – June 15, 2012 for
specific APIs
Technology: GS1 data matrix / GS1-128 linear / RFID.
Tamper evident labeling and visual codes
on labels.
Based on:
Item level: No
Sales level: GS1 data matrix with GTIN and S/N
Shipping level: RFID on shipper boxes and pallets
are preferred.
Data matrix not banned.
Data scope: GTIN (Global Trade Item Number),
GLN (Global Trade Location Number)
optional but recommended, S/N
(Serial Number)
Batch number and expiry date are
optional but there must be a link
between S/N and Lot/Exp.
california
Background: California Business and Profession
Code section 4034 – 4169
Pedigree requirements goes all the way
back to 1987 and is mandatory in many
states. However it’s only in a paper
based hard copy version and from
when shipments enter the US
Timeline: January 1, 2015 – July 1, 2017
Technology: Not defined
Based on: Not defined
Data scope: Full Pedigree in an electronic format
(ePedigree) from the original manufac-
turing site/line
Source name, registration number
(NDC), address, drug name, quantity,
dosage form and strength, date of trans-
action, sales imvoice number, container
size, number of containers, expiry date,
lot number, unique identification num-
ber. business name, registration number,
addresses and certifying person’s
name and address. Certification that
information is true and accurate.
US Overall
Background: PREDICT database run by DIOP
(Division of Import Operations Policy)
SNI guideline March 2010
OSD guideline
GDP guideline
Rx Tec delegated act
Tracking guideline (upcoming)
FDA will adapt the same angle as EU
Technology: UPC-A or EAN-13
Based on:
Unit level: NDC code
Sales level: NDC code
Shipping level: NDC code
Data scope: National Drug Code
(Static ID code of drug similar to GTIN)
denmark
Background: AMGROS (Danish purchasing
association for hospitals and clinics).
“Demands on barcodes for tendering
2013 and expected demands for
2014 and 2015”, May 8, 2012.
Minimum tender and purchasing
demands 2014-2015 are subject
to changes.
Technology: GS1 data matrix / EAN-13
Based on: GS1 standards
Item level: GTIN (minimum)
Sales level: GTIN (minimum)
Data scope: GTIN-14, lot number, expiry date and
S/N was part of prior version of tender
demands but has been taken out
“technical guidance regarding Identifica-
tion key, May 17, 2011, version 2”
canada
Background: Canadian pharmaceutical
bar coding project.
Joint technical statement v002.
February 24, 2012
Timeline: Phase 1: January 2008, Phase 2: April,
2009, Phase 3: 2010, Phase 4: December
2012 – December 2017
Technology: GS1 data matrix / GS1 Linear / RFID
(as supplement)
Based on: GS1 standards
Item level: GTIN (minimum)
Sales level: GTIN (minimum)
Shipping level: GTIN, lot number, expiry date (minimum)
Pallet level: GTIN (minimum)
Data scope: GTIN, lot number, expiry date, no S/N but
can appear .
If end user (hospitals and clinics) wishes.
The same goes for RFID.
Stated trough purchasing tender require-
ments (similar to AMGROS)
5

4. the supply chain
landscape
A Manufacturer
1. Production of medicine
2. Application of UMI to second-
ary packaging
3. Case packing
4. Pallet packing
5. Decommissioning UMIs
6. Shipping UMIs
i authorities custom officers
1. UMIs verification by inspectors
or customs
2. Batch recall report
medicines verification repository
authenticat
e number
upload number
h patients
1. Verifying UMIs
by mobile phone
2. Verifying UMIs
through a call
center
3. Verifying UMIs
on the internet
4. Verifying UMIs in
a retail pharmacy
B distribution hub
1. Verifying UMIs at goods receipt
2. Shipping UMIs
C wholesaler
1. Decomissioning UMIs
2. Re-packaging
D re-packagers
1. Decomissioning UMIs
2. Re-packaging
E internet
pharmacies
1. Verifying UMIs
of goods receipt
2. Dispensing UMIs
3. Decomissioning UMIs
f hospital
pharmacies
1. Dispensing UMIs
of goods receipt
2. Decomissioning UMIs
g retail
pharmacies
1. Verifying UMIs
at goods receipt
2. Dispensing UMIs
3. Decomissioning UMIs
A 360º approach
to serialization
j ManUfacturers packaging line
1. Serialization and tamper evident packaging
of sales units
2. Sales unit
3. Bundle
4. Shipper box
5. Pallet
Getonthe
righttrack
7Getonthe
righttrack
6
Serialization affects all steps on your product’s way from the manufacturing
line to the patient. Hence, you need to take a 360 look at your production,
packaging and distribution when developing and implementing your chosen
serialisation technology.
NNE Pharmaplan offers full circle support and we have the skills and resourc-
es needed to guide you smoothly and effectively through the multi-faceted
serialization challenges that arise in early planning and throughout the imple-
mentation project.
We can help you improve your business case by priori-tizing and coordinating
local and functional inputs, e.g. by balancing regulatory requirements with
technological wishes and possibilities and market requirements.
We are familiar with the critical interfaces between the various scientific and
functional aspects and know how to balance them to reach the most opti-
mum solution, which accommodates relevant regulatory requirements and
market and technology demands. Ultimately, this means increased control-
lability and efficiency and minimized risk for you.
Organisational
change management
Ensuring cross-organisational awareness,
understanding, capabilities and commitment
• Project kick-off and milestone reassessment
• Project communication
• Design effective organizational setup
and procedures
• Design and implement tools
• Build new competences and
understanding - training
A
B
C d
e f
g
i
j
h
UMI: Unique Medicine Identifier
benefit realization
Aligning serialization effort with strategic
intend and other business initiatives
Build and manage business case and
benefit realization plan
• Identify and prioritize business drivers
and requirements
• OEE baseline and improvement plan
• Prioritize and coordinate activities,
resources and deliverables across
projects, sites and functions
• Programme management
Facility design
Specifying, selecting, implementing
packaging lines
• Conceptual design
• Equipment specification
• Vendor management and
communication
• Design for OEE
supply chain
management
Analysing, designing and implementing
logistics
• Product supply chain analysis
• Contract manufacturing assessment
and management
• Cold chain, logistics and warehousing
automation it
Identifying, developing, validating
and implementing robust it
automation systems
• Manufacturing information systems
• PLS/SCADA
• System interfaces
• Serialization software configuration
• Vendor management
and communication
• Project management
GxP compliance
Ensuring right level of GxP compliance,
balancing risk, flexibility and efficiency
• Risk assessment
• Test plans
• Validation documentation
• SOPs
cost elements
SCADA / PCS / PLC
integration
Organisational
change management
Program project
management
Business case development
communication
Vendor management
OEE/optimization
performance
Warehouse solution
Master data management
Training
Systems integration
CMO implementation
Other
ERP implementation Systems Interface
implementation
Verification validation
Serialization System
implementation
Packaging line equipment
modification
SOP development
Improve
Solution Price range per line EUR
Fully integrated
with ERP
500.000 – 1.500.000
Serialization
+ Aggregation
200.000 – 700.000
Serialization 50.000 – 300.000
40%
40%
20%
Typical cost distribution
Corp Site Line
Serialization software
• Configuration
• Communication with vendor
• Interfaces
• Systech expertise

5. 8 9
Understand
• Regulatory status (serialization, GDP, pedigree, codification, etc.)
• Best practise in pharma industry
• Communication
• Stakeholder management (corporate, sites,
CMO, partners, suppliers, customers)
first deployment
• Pilot production
• Live test of roll out approach
Roll out
• Local interpretation of global implementation script
• Installation
• SAT/IQ/OQ
• PQ
• OEE optimization
• Training
• Securing harvest of benefits
• Setup of regulatory maintenance
Assess
• Checklist-based assessment
• Regulatory requirements
• Product and market overview
• Analysis of requirements vs. capability of processes
• Supply chain overview
• IT automation strategy
• Alignment with other intitiaves (corporate/sites/ partnerships)
• Stakeholder engagement
Plan
• Roll-out master plan
(including change management approach)
• Business case including benefits,
risks and budget estimation (+/-20%)
• Recommendations (technology, project organization,
vendors, compliance, turnkey vs. individual site
implementation, etc.)
Scope
• Execution model
• Time schedule
• Team set-up
• Pre-budget (+/-30%)
• Opportunities for business benefits
• Business case (key figures from industry)
• Risk (prioritized)
• Alignment with other initiatives
From corporate level
who does what
to site level to Packaging line / Ware house
Getonthe
righttrack
Getonthe
righttrack
Initiate – 1 month
What is the scope and consequences of the new regulations,
and how do they correlate to other changes and develop-
ments in production, planning, supply chain management,
it, sales and marketing, etc., which take place concurrently?
How can I take advantage of the demanded changes to
implement other changes?
A demand for changes can often be exploited to make other, op-
tional changes, which can potentially bring huge business benefits.
Such changes could entail late stage customization, oursourcing
to contract manufacturers, exchange or upgrade of technology or
processes and streamlining of production flow related to change-
overs, release, sampling, etc.
What is the business case, and what are the risks?
Typically, there is a lot of insecurity in relation to the financial im-
plications and risks associated with new requirements. What is the
invesment level?, how does it influence operational results?, and
what are the risk factors involved in making the necessary changes?
All those questions are essential in building a solid business case.
Analyse – 1-3 months
Is it necessary to re-assess the product portfolio in light of
the added costs and new opportunities/requirements for
changes in package format and design?
You may encounter challenges in terms of product profitability on
e.g. small product series for small markets. You need to make an
assessment of whether that should lead to changes in your product
portfolio.
What are the specific implications for the product flow from
API production through packaging lines and supply chain to
end-distributor on the different markets?
You have to identify which packaging lines, etc. are to supply which
markets at which volumes – and thereby determine the required
technology level for each line.
What is the level of technology readiness of my packaing
lines and IT systems (ERP and MES) and in my supply chain?
Does anything require change/upgrade/replacement/
development?
You need a clear assessment of the scope of changes that need to
be developed and implemented in order to proceed.
Execute - 6-8 months
How do I implement changes and improvements to my
packaging lines, in my supply chain and at my CMOs and still
keep my obligations to deliver? And how do I make sure I
take full advantage of planned shutdowns and maintance
periods?
How do I ensure that authority approvals are in sync with
the changes in production and package design, so that
the number of variants and the capital tied up in stock are
minimized?
If you’re dealing with different approval levels in different markets,
the number of new products variants can grow quickly, creating a
need for larger safety stock. This concern must be addressed.
How do I ensure effective implementation of new proce-
dures, processes and technology on the factory floor with
minimal reduction of OEE?
The required changes may have significant concequences for work
flow and work procedures, which all factory staff, QC and QA
people, etc. have to understand and comply with.
Design
• Global implementation script (templates, policies, change,
checklist)
• Detailed design
• FAT
• Training setup (global, local)
• Shipment
• GMP
• Global ERP/MES
• Risk approach
• Pre-installation
• Regulatory (registration)
all for
oneTo successfully implement a serialization concept – mitigating risks and
leveraging possibilities – it requires careful investigation into a number of
external and internal issues. From early planning and throughout the en-
tire implementation process, there are important aspects which require
scrutinizing, and this requires involvement from practically all divisions of
your organization.
In this section, we highlight the key questions that companies need to
ask themselves when converting their processes and business to new
requirements. Our approach to executing serialization projects are based
on a model containing three phases, and we have identified the most
critical questions in each of the phases.
For every project phase, we make available expert resources that will
ensure successful completion. Hence, we can jump in whenever and
wherever you need assistance. We can put together the ideal project
team, whether we supply resources for the entire team or supplement
your own resources.
Manufacturer
Task
NNEPharmaplan nnit
Equipment vendor
System vendor
Readiness
assessment
X
(X)
Project
management
X
X
Automation
solution
X
(X)
Commissioning
and go-live
(X)
X
URS
X
Line
integration
X
X
Qualification
X
(X)
X
Org. imple-
mentation
X
Solution design
(CD,BD,DD)
X
X
X

6. 10
References
A package solution
FIRST IN LINE
Establishing a serialization pilot line to pioneer
for global application
Our customer offers a wide range of healthcare
products within pharmaceuticals, vaccines and diag-
nostics, generics and consumer health to patients all
over the world.
With patient safety at top of mind, the customer is
putting much effort and many resources into apply-
ing anti-counterfeit and product authentication
measurements into their production machinery.
In October 2012, the company reached a major mile-
stone, when they completed the upgrade of the
first packaging line to comply with the US ePedigree
Factbox
Automation/IT services:
• Defining interface between serialization
system and existing automation and IT systems
• Writing conceptual design for local site
serialization solutions
• Writing URS/blue print for corporate and local
site serialization system to be implemented
• Rollout planning
• Creation of local and central staffing plans
for analyze and execute phases
• Calculation of serialization solution price
• Screening and selection of serialization
solution vendors
• Implementation and validation of warehouse
solution
• Assistance to corporate serialization team
in local site implementation at packaging line
• Detailed implementation planning including
critical shutdown period
• Implementation of tamper evidence on
secondary packaging material in parallel
with serialization implementation
Procurement services
• Procurement management of serialization
equipment to local manufacturing sites
• Procurement management of corporate
serialization solution
• Negotiation of price and contract with vendors
Validation services:
• Preparation of validation master plan
• Validation planning
• Control corporate and local CR cases
• Writing of overall solution URS
requirements for serialization and aggregation. The
upgraded packaging line – which is placed in the
customer’s key pharmaceutical plant – is to work as
a pilot line for testing the new serialization concept.
Over the next four years, the concept will be rolled
out to all packaging lines at sites across the world.
The upgrade of the pilot line entailed a changeover
from manual end packaging to an automized solu-
tion. This presented a challenge in terms of fitting
a large robot into the limited space of an existing
production hall. Also, scanners and label printers
had to be installed for each aggregation stage to
facilitate the necessary data collection.
BETWEEN THE LINES
Unique barcodes to prevent counterfeit
A vast number of people were involved in the project
which entailed work ranging from building a new
IT-infrastructure and adapting the logistics chain and
production processes through procurement of new
equipment and change of packaging materials to
release of new standard operating procedures.
NNE Pharmaplan provided support for factory and
site acceptance tests (FAT/SAT) and was responsible
for ensuring compliance with GMP requirements.
Moreover, we were in charge of coordinating
and supervising commissioning and for complete
qualification in all phases in connection with the
implementation of the serialization system and pal-
letizing robot.
NNE Pharmaplan’s pool of resources counts 350 highly
skilled consultants and project managers within
Automation IT and packaging lines as well as 30
consultants focusing exclusively on serialization.
All have hands-on experience from the pharma and
biotech industries.
NNE Pharmaplan has provided consulting services in
the serialization field to numerous customers, and
implemented and validated more than 60 packaging
lines worldwide to incorporate serialization technology.
Below we have highlighted three of our most recent
projects.
Our customer has initiated a Global Serializa-
tion Programme (GSP) to implement the equip-
ment and systems required to comply with
global codification and serialization require-
ments.
The program sets out to define a common standard
for serialization processes across the entire supply
chain from production to warehouses including
equipment, automation and IT solutions. Each step
in the supply chain checks and reports which serial
numbers have been received and shipped (from/
to whom) in order to constantly track the individual
product.
So far, major implications have included the replace-
ment of packaging lines, changes in warehouse
processes and implementation of new IT solutions.
All solutions are designed with high flexibility in mind
in order to accommodate a diverse and continuously
changing landscape of requirements.
NNE Pharmaplan is assisting in all aspects of the pro-
gramme realization effort and is providing resources
within the fields of automation and IT, procurement
and validation.
Even though our customer is not one of the
companies to be most affected by counterfeit,
the company has taken important steps to pre-
vent counterfeit issues going forward.
In close collaboration with NNE Pharmaplan and
NNIT, they are currently introducing a unique 2D
barcoding system into their worldwide production
plants. The barcode is printed on the packaging and
contains information on where the product origi-
nated as well as a unique identification number.
From the drawing board to production
The company initiated their serialization efforts in
2009, when they asked NNE Pharmaplan and NNIT
to assist them in making the right choice of technol-
ogy and subsequently to develop a solution which
would be eligible for global rollout throughout the
organization.
The collaboration continued through the implemen-
tation phases, where NNE Pharmaplan and NNIT
performed impact assessments of all global sites to
identify the amount of work to be done to introduce
the 2D barcoding system to each site.
The effort requires the production machinery and IT
systems to be converted in order to accommodate
the 2D barcode system.
Getonthe
righttrack
11Getonthe
righttrack
10

7. Project references
Basel
Clarens-Sur-MontreuxSan Francisco
Irvine
Moscow
Tianjin
TEDA
Kuala Lumpur
(Selangor)
Bangalore
Noida
New Delhi
Mumbai
Frankfurt
(Bad Homburg)
Stockholm
Uppsala
Lund
Shanghai
Lyon
Copenhagen
Kalundborg
Hillerød
Hjørring
Guangzhou
Boston
(Cambridge)
Research Triangle Park
(Morrisville)
Philadelphia
(Berwyn)
Cork
(Kinsale)
Chartres
Marburg
Skt. Petersborg
Offices
Curitiba
Brussels
Tangerang
Jakarta
São Paulo
track record– local projects for a global issue
NNE Pharmaplan is the world’s leading engineering and consulting company in the complex field
of pharma and biotech. We cover all segments from biopharmaceuticals and vaccines to medical
devices and help our customers develop, establish and improve their product manufacturing.
NNE Pharmaplan employs 1,700 people at more than 30 locations around the world.
Engineering for a healthier world – our role in an industry that improves people’s lives worldwide.
To learn more about our company, please visit our website.
NORDIC
Lars Olsen
Subject Matter Expert
+45 3075 7362
lao@nnepharmaplan.com
europe
Thomas Bill
Serialization Business Consultant
+45 3079 0489
tobl@nnepharmaplan.com
NNIT
Torben Vogt
Subject Matter Expert
+45 3075 4338
tovo@nnit.com
USA
Gilad Langer
Subject Matter Expert
+1 4154056743
gidl@nnepharmaplan.com
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nnepharmaplan.com
Global Danish
manufacturer of insulin
Project:
Global solution -
serialization + aggregation
Chinese solution -
serialization + aggregation
Global Swiss pharma-
ceutical manufacturer
Project:
End of line serialization
+ aggregation solution
Global american pharma-
ceutical manufacturer
Project:
Serialization requirement
and product analysis
Product tracking strategy
Global manufacturer
of skin treatments
Project:
Serialization requirement
and product analysis
Product tracking strategy
Global Danish
manufacturer of anti-
infection treatments
Project:
Serialization requirement and
product analysis
Product tracking strategy
Scoping and planning of global
serialization solution
Version2-April2013