SERIALISATION

IMPLEMENTATION TIMELINE

2015 HANDBOOK

Pharmaceutical
Serialisation &
Traceability

Brought to you by
TABLE OF CONTENTS
Foreword
3
Timeline Overview
4
Pre-Implementation Phase
5
Execution Phase
9
Multi-Site Implementation Phase 10
Post-Implementation Phase
13
Acknowledgements 14
 Foreword
Following the release of the EU Falsified Medicines Directive in 2011, the pharma
market is in the process of becoming fully serialised ahead of 2018s deadline.
Market players currently stand at different stages of the implementation process:
Some yet to implement, some mid process and others at the final stages -
sharpening their strategy.
All firms should aspire to execute a sustainable approach to serialisation,
however the specific implementation strategy remains to be determined on a
company-by-company basis.
Michael Kinsella Industrial Operations Deputy Director at Servier said: Breaking
the project into manageable sections and [having] a modular approach is the
essential way to manage it and to not to forget about the long term costs of each
module.
There are plenty of company decisions, not only industry decisions, about what
kind of organisation will be required in each company. And this question can only
really be answered by each company, because each company has a different type
of supply chain or a different size or a different philosophy. So, theres really a lot
of work to be done on the strategy of the long term maintenance and ownership
of this new profession in the pharmaceutical industry.
In the absence of a one-size-fits all-approach, after consulting with industry
experts, Pharma IQ proposes this framework for key milestones within a
sustainable serialisation strategy - in which firms can choose customize in
relevance to their requirements.

NOTE:
This article and its contents are intended for educational and insight purposes and should not be taken as professional advice.

www.pharmaserialisation.com
 Timeline Overview
Pre- Implementation Phase
v Initial Approach: Engage with
stakeholders and initiate a program
v Awareness: Acquire understanding
on key challenges and requirements
v Strategic Engagement

v Scoping URS Creation

v RFI/RFP Vendor Selection
v Functional Specification

Execution Phase
Pilot Initiation c
Validation c

Multi-Site Implementation

v Full Roll Out

v Level 4 - Integration and

Centralisation

Post - Implementation

Maintenance and Ownership c

Data Optimisation c

SERIALISED

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Pre- Implementation Phase

Pre- Implementation Phase

INITIAL APPROACH:
Engage with stakeholders and initiate a program.
This stage focuses on the development of the project, incorporating a strategy, a
project roadmap, project charter and the identification of what resources will be
needed and the persons responsible.

AWARENESS:
Acquire understanding on key challenges and requirements.
This awareness will help firms foresee the condition of the road ahead, allowing them
Execution Phase

to optimize and conduct damage control where possible.

These project requirements concern laying the foundations to print, verify and
generate the reports before the product leaves the factory and then manage global
data exchanges, while considering the relevant national reporting requirements that
should be respected.

KEY CONSIDERATIONS:
Multi-Site Implementation Phase

Fraud Identification
The driving objective behind serialisation of course is to identify counterfeit items,
on this matter, Michael Kinsella notes that the following considerations should be
answered:
What if we do find false products? What are the processes and how will this project
specifically help in detection or dissuasion of those counterfeit products?
He adds, At the moment, were very much all hands to the pump to get the solution
in place but the end game of this, in the spirit of the law, it is to have authentic
product on the market and to be able to verify that as authentic. So, if you find [an]
inauthentic product, how can you use this system to speed up the response to the
authorities? How can the data be exploited in a way that it can be proven to be
beneficial?
Potential Challenges
Post - Implementation Phase

Michael Kinsella notes that challenges can be expected in the transition and
maintenance of the operational efficiency of factories.
1. The long term day-to-day impact on the new process: It may take longer to
produce a typical work order or to complete a changeover.
2. Operational impact from transition: Not all lines may be equipped at the same time
causing issues with planning in factories where some lines producing for a product
may be out of service for a few weeks because of the aggregation installation.

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Pre- Implementation Phase

Pre- Implementation Phase Continued

Can that product be planned on a different line? Do you have to buy tooling or do
you have to build stock to manage the transition?

DONT FORGET
Harmonisation:
There could be opportunities in the project to reduce or to automate some activities
for operators.
Michael Kinsella notes:
Execution Phase

v For example, if you print on every box and verify the print is correct then we can
eliminate the human check for the print which could reduce the risk of a human
error because 100% of the boxes will be checked automatically.
v Do you need to have a physical check to count the number of boxes in an in-
process quality control? Consider whether harmonisations of quality checks to
check the number of boxes can be scheduled to happen automatically if you
have aggregation.

STRATEGIC ENGAGEMENT:
Multi-Site Implementation Phase

Provide a definitive roadmap and strategy which accounts for the projects long term
financial impacts.

KEY CONSIDERATIONS

Elements to define
v Code grading - Integrating as much data as possible into code.
v Returns- An expensive aspect which some in the industry shy away from
discussing, however its a key aspect to prepare for.
v Security issues - How will you secure the data
v IT Infrastructure

THINGS TO AVOID:
Post - Implementation Phase

Short-Term Financial Views

Michael Kinsella notes: If you go for cloud-based systems you may have ongoing
unit costs every number you put on the market you have to pay for. Alternatively,
you can take strategic decisions to internalise activity to try and control the costs in a
certain way.

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Pre- Implementation Phase

Pre- Implementation Phase Continued

SCOPING URS CREATION
Obtain management buy-in to the program and work to initiate specific long
lead-time activities. At this stage typically companies develop very specific user
requirements specifications or URS.
Typically, a URS document is created for each of the following three areas:
v The Enterprise systems that are used to manage the serial numbers for the
packaging systems
v The Packaging systems
Execution Phase

v The warehouse and shipping systems

KEY CONSIDERATIONS

URS documents are independent

The URS documents are developed independent of any specific commercial
solutions and closely tailored to the business practices of the company. URS
documents are used to develop vendor selection materials, vendor selection being
Multi-Site Implementation Phase

the third phase. Consider Developing unique URS documents for business units - Bill
Fletcher reminds that in very large companies with different business entities, it may
be necessary to develop different URS at each of those levels for specific business
units.

DONT FORGET

Detail is Vital:
Bill Fletcher provides insight on how vital this stage isin avoiding possible failures
down the line.
He states: What I often see as a failure in some of the projects that Ive come into
after theyre partway through the project, is that the user requirements were simply
too vague or too or too focused on a specific solution brand. The URS failed in
their ability to precisely measure and contrast the various solution offerings, and
so unknowns crept into the project and were discovered later on in the project,
Post - Implementation Phase

requiring additional systems to be acquired. They might have prevented that and the
delay if the requirements were more measurable earlier on.

In the 2015 Serialisation and Traceability Report, the majority of

participants predicted that 100,000- 500,000 would need to be
invested in technology solutions for their serialisation strategies.

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Pre- Implementation Phase

Pre- Implementation Phase Continued

RFI/RFP VENDOR SELECTION:
This stage involves reaching out to suitable vendors and using the USR to match
their capabilities to your needs. In regards to the in-factory solutions some specialists
break these down into three categories: The printing and verification of the print, the
aggregation step and then the warehouse management. All of which are governed
by a software which can send and receive numbers before shipment onto the
market.

KEY CONSIDERATIONS
Execution Phase

Grill The Providers

In regards to his experience, Bill Fletcher noted: Ive typically done this by developing
documents that require the vendors to answer yes or no to specific questions relating
to the individual business requirements. Then this information is used to provide an
objective score comparing the various vendors. The top two or three vendors which
meet the majority of the business requirements are selected and asked to present their
solutions and products.
Find A Gap Patch the Hole: In regards to where there is a void in a vendors capability to
Multi-Site Implementation Phase

fulfill your requirements, Bill Fletcher states that firms should contemplate developing a
cap analysis and locate solutions to cover that business need.

THINGS TO AVOID
IT solutions that impose restrictions
Michael Kinsella explains: A key aspect in our project is that were looking for
solutions that are connectable. IT solutions that are connectable, but they dont
impose certain connections to other pre-defined systems. The idea of connectivity
is very important and gives you the ability to have a modular approach - you could
have a system which is scalable.

FUNCTIONAL SPECIFICATION
Once the vendors have been selected and contracts executed, then its a common
practice to develop a functional specification- a document that takes the user
Post - Implementation Phase

requirements that work for the business, and compares them to the capabilities of the
commercial solution. Following this, the commercial solution is then examined for ways
it can be configured to meet specific business requirements. This document allows you
to identify any areas where the solution doesnt fully align with all of the needs, and then
look for alternative separate solutions to accommodate those gaps.
Bill Fletcher points out: Its a good practice because you can identify problems before
youre committed to actually acquiring and installing and configuring the system.

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Pre- Implementation Phase

Execution Phase

PILOT INITIATION
Initiate a pilot program using one line, with a view to iron out all issues prior to full
implementation.

The functional specification is applied to install, configure and test the chosen
solutions.

Integration tests can be conducted between all of the various systems: The
enterprise, the packaging and warehouse systems.
Execution Phase

DONT FORGET

To go forwards, you may have to look back In the opinion of Bill Fletcher: During
the cycle, at any time from selecting the vendor on, you may find that theres a need
to go back and acquire other systems, or you may find that the solution that was
selected did not meet the requirements as promised or as expected, and so theres
Multi-Site Implementation Phase

always the potential for a project to look back on itself.

VALIDATION
Validation is a common practice in life sciences. It looks to confirm the solution
meets the desired needs consistently and in a low risk fashion. After this stage, the
solution will typically go live.

Validation refers to the functional requirements and the user requirements, it simply
asks questions on whether this solution accomplishes the particular business
requirement.
Post - Implementation Phase

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Pre- Implementation Phase

Multi-Site Implementation Phase

FULL ROLL OUT
This stage focuses on ensuring the successful roll out of the serialisation program to
all business units, while accounting for specific country requirements.

CASE SNAPSHOT
Michael Kinsella mentioned about how Servier started the process of placing the
printing and verification machines in France back in 2010 which was a key first step
in the global serialisation programme for Servier.
Execution Phase

We started to print static Datametrics codes on all of the French products and
to do this we had to equip all of the production lines that are in France, about 22
production lines, and also some production lines which are producing outside of
France but for the French market. We decided to pick one type of printing and
verification machine which was developed and tested specifically for France
Looking ahead, Michael Kinsella forecasts: Before 2018, we will have responded
to the Korean, Chinese, Brazilian, Saudi Arabian [markets] and maybe some other
Multi-Site Implementation Phase

small markets like India. When Europe comes, at the end of 2018, we should be fully
operational to be able to generate reports in all of those markets.

KEY CONSIDERATIONS
Harmonisation is Key
Experts note that the key is to have as much harmonization in the factory as possible.
He adds: Also, there will be harmonisation of certain processes; certain process like
labelling is a very important aspect, [to] have harmonised: A way to generate labels
and to generate aggregation labels in particular. That can be done [according to the
respective] international standards, but you should have a central governance of
some kind to ensure that the labels are managed in a harmonised way.
Post - Implementation Phase

Copy and Paste Formula to production- Michael Kinsella mentions how all Servier
factories have the same software, same printing machine and theoretically the same
philosophy for aggregation. Almost a kit that will be put on top of all the case
packers that exist in the factories. All case packers are not identical but the function,
the process and the number of devices that we used will be copy and pasted.

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Pre- Implementation Phase

Multi-Site Implementation Phase Continue

DONT FORGET

Country specific legal requirements can be challenging

Brazil Has been labeled to hold complex process on entry into the country,
requiring the use of a broker at the airport for a detailed exchange. They acquire
serial numbers from the airport to your system.
Saudi Arabia The Regulation has not yet been fully worked out here, resulting in
confusion in what the data transfer will look like. The country specifications here
from a technical perspective require pharma firms to design the process around the
Execution Phase

system. So your system needs to be adaptable.

China They allocate the codes that pharma firms must use. Can be a lengthy
process approval presenting difficulties for new products.

LEVEL 4 - INTEGRATION AND CENTRALISATION

This stage entails the integration of local systems and databases with a national or
regional centralized database. This will include: Barcode readers, MDMS, EAI, the
delivery chain network, etc. In the 2015 Serialisation and Traceability Report, the
Multi-Site Implementation Phase

majority of participants labeled the integration of enterprise systems as their biggest

operation challenge.

KEY CONSIDERATIONS
Managing localization:
A small level of slight variations may occur from site-to-site that has to be managed.
This localisation factor may arise due to language, IT architecture, geography or the
physical structure of the factory.
Michael Kinsella reminds, however, that once this system goes into place it should
all lean towards a central management or a central expert group that can help and
support all sites and maintain as much harmonisation as possible in factories to
simplify the maintenance required and to allow for experience sharing.
Post - Implementation Phase

DATA COMMUNICATION
In regards to the central data management functions outside of factories, Michael
Kinsella notes that this entails the consolidation of all of the reports and the links
between distribution chain, wholesalers, logistical partners or production partners
and, of course, with the markets or the government agencies, via a corporate
repository system.

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Pre- Implementation Phase

Multi-Site Implementation Phase Continue

KEY CONSIDERATIONS

A Partnership for The Long Haul:

Central data management service [requires] an organisation, a full time organisation
of some kind. Whether its a service management or an actual service delivery has
to be decided but that service, then, would be responsible for the ongoing reporting
required forever. Michael Kinsella
Execution Phase

Data Pooling:
As the amount of countries increases that you are fully serialised within, a
centralised service for data reporting to markets should be able to function in
alternate directions. In Michael Kinsella experience the explains that this assists with
receiving numbers when his firm acts as a CMO for other companies and also for
sending numbers from factories when numbers are generated internally and then
sent outside.
Multi-Site Implementation Phase

Consider Consolidation with Data Carrier Selection:

In regards to the site server and line controller system, Alex Ulbrich, Project Manager
IT Serialisation, Vetter Pharma noted that his firm decided on at least one site server
per region to recommend - One for Europe, one for Asia, one for America, etc.
Then the same provider was chosen for the line controller also in order to prevent
difficulties with the interface between the two aspects.
Post - Implementation Phase

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Pre- Implementation Phase

Post - Implementation Phase

MAINTENANCE AND OWNERSHIP:
This stage involves the monitoring of the programmes performance when fully
implemented.
Experts note that the maintenance of this system and its solutions should be seen as a
new profession, and its financial ownership should comprise the initial investment as well
as the costs for long term management.

KEY CONSIDERATIONS
Fluid Communication:
Execution Phase

On this matter Michael Kinsella notes: I would say that theres a lot of communication
to be done internally. No matter who leads the project, it is easily a half or a full-time job
for one person to communicate constantly within the company to explain the impact
and to be ready for the questions that will come. He notes that queries are likely to be in
connection to:
v A report not being sent,
v A report being corrupt,
Multi-Site Implementation Phase

v Being unrecognizable in format, or,

v Requiring changes in format

DONT FORGET

Be Open to Flexibility:
Alex Ulbrich spoke of a similar situation in regards to a cloud based solution
implemented at his firm, due to issues with process compatibilities with the internal
validation department, they had to switch back to internal communications and decide
on a new route.

NEW OPPORTUNITIES:
This step is focused on utilising the advantages of the serialisation process beyond the
objective of compliance.
Post - Implementation Phase

Data Optimisation:
A lot of present discussion in the industry is around exploring the ways in which
serialisation data could be useful. Specifically:
v In assistance with enabling targeted product recall.
v Helping with stock management in the future. Informing operators of what numbers
are where.
v Understanding the authenticity and movement of the product to create a more
refined manufacturing process

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Pre- Implementation Phase

Post - Implementation Phase

Change management evolutions:
Change management evolutions in the markets may require revolutions in solutions,
training and change management within factories. Michael Kinsella pointed to the
prospect of a global change management processes.

SERIALISED
Execution Phase

ACKNOWLEDGEMENTS
Thanks to all specialists that assisted with the research for this project. Including more
specifically Bill Fletcher of Pharma Logic Solutions, LLC, Alexander Ulbrich of Vetter
Pharma and Micheal Kinsella of Servier.
Multi-Site Implementation Phase

RESEARCH SOURCES
http://www.gxpsystems.com/services-serialization.html
http://www.domino-printing.com/Global/en/DocumentLibrary/The-Hidden-challenges-
of-Pharmaceutical-Serialisation.pdf
http://pharmaceuticalcommerce.com/special_report?articleid=26841
http://ec.europa.eu/health/files/falsified_medicines/2012-06_safety-features/efpia-eaepc-
girp-pgeu_en.pdf
http://www.pharma-iq.com/regulatory-legal/articles/pasi-kemppainen-on-implementing-
serialisation/
http://www.pharma-iq.com/regulatory-legal/articles/how-to-successfully-use-anti-
counterfeiting-techno/
Post - Implementation Phase

www.pharmaserialisation.com
 Whether the final
delegated acts are
announced next week or
next year, the fact remains
that planning a sustainable
strategy will determine
your commercial success
as an organisation.

Geneva Switzerland, 2nd - 4th November 2015

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