A unique blend of expertise
Serialisation Case Study: Moving From Theory to Practice
Daniela Geiger, Product and Service Manager
October 23, 2017
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Counterfeiting: A
big loss for
Pharma
companies
Counterfeiting products may contain incorrect quantities and qualities of active
ingredients or none at all
Estimated size of the counterfeit drug market ranges from $75 to $200bn*
Lost of trust in the pharmaceutical product and negative brand impact
Why is serialization such an important topic in the pharma industry?
Risks for patients
Tens of thousands of lives are adversely affected through this fraudulent act
Substandard or incorrect formulation can prolong illness, create resistance or
even result in death.
Changing in
regulatory
requirements
By 2019, the majority of the global drug supply will essentially fall under some
form of serialization requirement.
Already implemented serialization programs: Turkey, India, Argentina, South
Korea and Saudi Arabia
Next implementations:
U.S. market – November 2018
European market – February 2019
Drug counterfeiting – easy to define, hard to combat
*Source: World Finance (2012): ‘Trade in illegal medicine hits pharmaceutical sector’
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Why did Vetter initiated the serialization project in an early stage?
Meet customer specific requirements
Gain experience better reaction to challenges on
the way
Commitment to a safer & controlled supply chain
Commitment to global regulatory requirements
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Process steps of a serialization project
Evaluation of synergies and impact on current systems
Workshops with possible solution providers
Generation of process map
Gap analysis IT and production
Overall costs and implementation timelines
IT solution Customer projectEngineering solution
Concept study
Implementation of
customer specifics
according to user
requirements,
specification, incl. test
& qualification runs
Line Controller
Serialization Unit
Manual aggregation
unit
Central IT Solution
(Hardware/ Software)
Site Server
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From Vetter’s experience, implementation of serialization takes about 2 years
Year 1
Q1 Q2 Q3 Q4
Year 2
Q1 Q2 Q3 Q4
Concept
study
IT solution
Engineering solution
Customer project
Year 0
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What are the general challenges of a serialization project?
General Challenges
Supplier selection
IT implementation / IT strategy
Technical implementation
Regulatory requirements
Customer requirements
Project prioritization compared to
other internal, complex projects
– Make resources available
Fast decision of management required
– Tight schedule from market – regulatory
requirements
– High requests at suppliers (consultants
and manufacturer of the machines)
Internal
Challenges
External
Challenges Timeline - regulatory requirements
of the different countries:
Customers wait as long as possible
before starting with serialization
Shortened timeframe for customer
projects makes pressure on internal
ressources
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What are the main challenges of the teamcooperation?
IT
Engineering
Project Manager
Customer Project Manager
Product Manager
Development Services
Qualification & validation
Regulatory Affairs
Production
Quality
Internal
team members
External
team members
IT Consultants
Software Suppliers
Hardware Suppliers
Understand different thinking and
expectations to meet overall
project objectives
Try to avoid the “serialization
fatigue”
Keeping the motivation high within
the project team
Understand that after
implementation there is still work
to be done (change in processes,
the economic impact, etc).
Project Team Challenges
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What are the main challenges in managing a customer project?
Dynamic requirements
Regulatory
Customer
Vetter internal
Supplier capabilities
The goal is to meet the
specific requirements as a
CDMO: Interface specifications
Data exchange requirements
Serialization levels
Design / Code structure
Reports
Flexibility
Change of artwork: Rework of packaging
New material codes
Change of date format
Customer specific code
information
Timing
Same regulatory timelines
Customer-specific timelines
Different projects might run
at the same time (internal)
Training of operators on
process specific
requirements
Creating new BOMs, MBRs
and packaging
specifications
Customer support / Consulting
Find out customers’ serialization needs and create a catalogue with customers’ requirements
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Different serialization needs – Big Pharma vs. Smaller Biotech
Situation Big Pharma Smaller Biotech
Several years of
experience with
serialization
Knowledge of the
regulatory requirements
Own standard concerning
Serial number request and
response
Reporting is defined and
specified
Customer requirements Big Pharma Smaller Biotech
Expect support from the
CDMO
Advice on implementation
Serial number
management system
Packaging lines
Main challenges Get all strategic CDMOs in time
“Serialization Ready"
To be in time “Serialization Ready"
less more less more
less more
no yes no yes
less more
ownexternal
(CMO/Cloud)
ownexternal
(CMO)ownexternal
(CMO)
ownexternal
(CMO/Cloud)
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Mobile Unit or Line up-gradePros and cons of the technical options
Very flexible solution for
smaller batch sizes and
manual packaging
Mobile Unit Line up-grade
Fix line solution for big
batch sizes and a high
degree of automatization
Line speed
reduction
High volume
capacity
Manpower
No packaging
line influence
SHORT-TERM
LONG-TERM
“Standalone” system Qualification has a high
influence (during qualification)
on packaging line
Reduction of line speed Less reduction of line speed
Suitable for smaller
batch sizes
High efficiency for big
batch sizes
Additional manpower is
needed
No additional manpower is
needed
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Benefits of a mobile unit for Vetter
Start serialization with a mobile unit due to the
following reasons:
Short-term and quick solution
– Short time for implementation
– Quick realization of customer requests
Gain experience for a later line up-grade
– Optimization of processes for a short time of the packaging
– Training of production
Offline qualification / validation
– No direct impact on the lines
Flexibility
– Application on all lines
– Produce serialized products for all customers –
independent of line
Example: mobile serialization station
Example: mobile aggregation station
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Serialization interface options for IT
In-house
solution
In-house solutions enable
companies to create, store, and
manage serial numbers and
their hierarchies from the carton
(item level) to the pallet in their
own IT landscape.
Cloud solution
Cloud solutions enable
companies to create, store, and
manage serial numbers and
their hierarchies from the carton
(item level) to the pallet via a
service provider.
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Vetter’s planning approach – line up-grade with fix serialization stations
Rollout plan – line modification
Strategic decision for a partner
Planning security
Established teams
Optimized processes
Same contact for all lines
Long-term planning by our own team at the supplier
Cost reduction
Acceptable plan concerning downtimes and resources needed
Priority due to the country requirements and complexity in the line
Compatibility of the systems:
Existing line equipment
new serialization system
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Our Vetter approach – one expert to bundle serialization competences
Serialization Process Manager tasks:
Coordination of interdisciplinary teams
Creation, maintenance, and communication of the
questionnaire to the customer
Coordination of SOP adjustments for serialization processes
Creation and maintenance of SOPs for serialization
SPOC (Single Point of Contact) for serialization inquiries
(internal & external)
Part of the expert team‚ ‘serialization’
Communication with the QPs (Qualified Persons) and
implementation of their requirements
Determination of country-specific requirements
Vetter Serialization Process Manager –
main contact for serialization questions
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Bundle serialization expertise by creating an expert team
Serialization expert team
Process Manager – main contact for serialization questions
Consulting of our customers in all serialization questions – before, during and after a project
Meet at regular intervals to discuss the different customer and regulatory requirements
Discuss progress and challenges in different projects
Getting experience through the projects and knowledge transfer
Make use of experiences, gained in collaboration with external and internal customers / suppliers
Serialization of a new product
Quotation and
order phase
Definition product require-ments
Create material
Docum.
Manage-ment
Planning
SCM
Technical implement-
tation
Qualifi-cation
Commer-cial
productionStock
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Smart Factory
(Industry 4.0)
Serialization meets current and future digital standards
Serialization
Serialization is a part of the Smart Factory concept
An important step in the direction to a digitalization in production
Production is therefore more dependent on IT systems (farewell to paper based,
digital starts now!)
Chances Better and more effective process with less human error
Cost optimization and time savings
Challenges Regular computer based trainings to employees
Maintenance phase should be 100% coordinated with Engineering
IT systems should always be available