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

A unique blend of expertise

Thank you for your time and attention!