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Serialization Whitepaper

Overcoming the practical challenges of pharmaceutical

serialization, best practice deployment and achieving

business benefits

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Introduction and Executive Summary

Serialization entails adding a unique identifier to single saleable units of prescription and some other

medicines so they can be tracked and authenticated throughout the supply chain. Requirements for

serialization are already active in some parts of the world and they will be obligatory in most major

markets within a few years. Pharmaceutical manufacturers need to act soon or risk fines, loss of

market share and damage to both reputation and stakeholder confidence.

In this whitepaper we aim to show that, while challenging, serialization is achievable and can even

bring wider business benefits, providing the process is well planned and executed.

This white paper sets out a roadmap for the successful implementation of a serialization programme

applicable to pharmaceutical companies of any size and complexity. It is based on practical

experience of implementing serialization for some of the world’s largest companies. Important

lessons have been learnt, and we are keen to pass these along to the industry as a whole.

Whitepaper Structure:

Part 1, The Road Ahead, explains what serialization is, outlines how we got here, and discusses the

confusion around dates and requirements in different territories.

Part 2, Assessing the Journey, examines the business benefits to be gained from serialization, as

well as the major challenges and hurdles to be overcome. If you are already familiar with most of

that content, you may wish to skip straight to part two.

Part 3, The Roadmap, sets out a detailed project architecture based on our experience of real-world

serialization implementation. We outline the core four stages and 14 steps involved in a serialization

programme, taking you from initial assessment through to on-going support of a successful project.

Part 4, The Journey Begins, discusses how to identify the right partner organisations. We also

include key recommendations for a successful serialization implementation.

The Road Ahead

Assessing the Journey

The Roadmap

The Journey Begins

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The Road Ahead

Assessing the Journey

The Roadmap

The Journey Begins

Part 1: The Road Ahead

What is Serialization and who is affected

The background to Serialization

The history of small steps towards Serialization

The situation today

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What is Serialization – and who is affected

Pharmaceutical Serialization requires drug manufacturers to add a unique code to the packaging of

medicines and maintain a database of the serial numbers to establish the authenticity of the

product. It will allow the manufacturer, regulators and other interested parties to electronically track

a drug all the way from production through all stages of the supply chain until it reaches the patient.

Using the serial code on each individual drug box (a “Commercial Saleable Unit” can be a carton,

bundle, case, pallet or a combination of these) companies will be able to tell the source of packaged

products and trace them back to the original suppliers, the date when the drug was made, the

machine used and the conditions that existed at the time. In Track&Trace markets companies will

also be able to identify which pallet the drug went into, where it was stored in the warehouse,

where it was moved to and where it ended up.

Typical logistic levels for full Track and Trace Serialization

The scheme is being rolled out globally but implementation is staggered, and the requirements and

regulations differ widely across various markets, countries and geographies.

Serialization mainly applies to prescription drugs, though some others are also involved, and these

new requirements will soon become an essential part of the packaging process in drug

manufacturing.

It is likely to affect any and all companies working in the Life Sciences, including pharmaceuticals,

biotechnology, medical devices and vaccines development.

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The Background to Serialization

In 2004, Veronica Diaz was a healthy 22-year-old woman living in Viedma, Argentina, though she

suffered from mild anaemia. The iron injections prescribed by her doctor and given at a public

hospital made her extremely sick, however, and she died of liver failure after the seventh treatment.

* There was nothing wrong with the diagnosis - but the drug administered was a highly toxic

counterfeit. Unfortunately, she wasn’t alone. At least one other woman from Argentina died the

same year from the same counterfeit batch. And such stories are the tip of the iceberg.

Fake vaccines killed 2,500 people during a meningitis epidemic in Niger in 1995.*

The same year 89 children died in Haiti in after taking a paracetamol cough syrup prepared with a

toxic chemical used in antifreeze. Thirty more infants died in during a similar incident in India in

1998.*

A 2001 Wellcome Trust study in South-East Asia found that 38% of anti-malarial drugs on sale in

pharmacies did not contain any active ingredients.*

The counterfeiting of drugs has become a massive business - estimated in the tens of billions of

dollars per annum. It kills people, it damages trust and it harms the reputations and business

interests of reputable and honest manufacturers. Not surprisingly, the world wants action.

{*Source: World Health Organization -

http://www.who.int/medicines/services/counterfeit/impact/ImpactF_S/en/ )

A History of Small Steps Towards Serialization

The trend towards serialization worldwide has come about mainly because of the increase in drug

counterfeiting, adulteration, misbranding and diversion. There are also concerns over the bulking up

of medicines with placebo.

The trend towards serialization can be traced back at least as far as 1987 and the enactment of the

Prescription Drug Marketing Act in the USA. The legislation sought to increase safeguards within the

drug distribution system, but many of its measures didn’t come into force for almost 20 years. By

then, things were changing worldwide.

In 2003 Belgium introduced sequential codes to act as a unique identifier for all packs of medicines.

In the same year the US FDA (Food and Drug Administration) established its Counterfeit Drug Task

Force.

A year later California passed legislation mandating a pedigree for all shipments of prescription

drugs. In 2009, Brazil followed suit with legislation that introduced electronic track and trace

requirements.

By 2010 The European Directorate for the Quality of Medicines had launched a pilot study of a track-

and-trace programme. Meanwhile other countries such as South Korea and China were taking

similar measures.

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In April 2012 the US Senate passed the Securing Pharmaceutical Integrity Act which required unique

serial numbers at the smallest saleable unit level of prescription (and some other) drugs. In 2013 the

US Drug Quality and Security Act (DQSA) mandated serialization, superseding all previous US state

legislation and at a stroke fundamentally changing the pharmaceutical supply chain.

It was clear that serialization had become a necessity for pharmaceutical firms. However, while

legislators worldwide scurried to introduce new rules, the dates for implementing those

requirements kept moving back - as Governments and industry bodies became more aware of the

difficulty of introducing effective processes.

For the average pharmaceutical firm, trying to focus on core business, keeping track of the new

regulations and their timelines is an almost impossible task even within the major markets. It is not

only the timings that are different, but also the requirements and the philosophies behind them.

California, for example, has focused on adopting the ‘ePedigree’ approach which tracks movements

of a drug through each node in a supply chain. Across the Americas the emphasis is on track and

trace and the ability to associate cartons with cases – and is perceived by many as primarily a way

for companies to avoid blame and reduce the risk of being sued.

In Europe, however, the emphasis is on authenticating drugs at the point where they are dispensed

to patients, with protecting patient safety the primary concern. Companies are being left to develop

their own strategies based on Government regulations, with fines in place for incorrect data.

China, on the other hand, has decided to produce the serial number codes centrally, with the

Government controlling and owning the data.

It seems as if each country is determined to take its own view on how the scheme should work,

together with its own regulations and timeline. It’s a confusing patchwork of rules with no

overarching regulatory framework. Will things become clearer over time? Probably not. The

requirements are likely to keep evolving, with regulations in various markets moving in different

directions and at their own pace. But the future could bring many more challenges: in time, every

pocket on a blister pack might need its own serial code. One day, companies may even add chemical

markers to a drug as a further means of identification, as happens today with petroleum products.

That is a possibility for the future. Today, for all pharmaceutical companies wherever they are based

and whichever markets they serve, there is one essential element common to all of the new

regulations and requirements currently taking shape around the world, and that is serialization.

To meet the new rules, pharmaceutical companies will need the ability to add a unique code at the

point of manufacture and maintain a database so that it can be tracked along the supply chain to the

point of sale.

There may be more requirements. The exact details may change over time and from location to

location. But that fundamental ability to add the code and keep control over the data is the building

block on which regulatory compliance must be built.

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The Situation Today

The situation today is that by early 2015 some countries - notably South Korea but also to an extent

Turkey and China – have already introduced drug serialization requirements. Many pharmaceutical

companies have introduced stop-gap measures to meet these local requirements - for example by

printing special packaging for specific markets containing a unique code, usually performed locally.

These solutions tend to be clunky, neither cost-effective nor scalable, and probably not sustainable

for more than a year or two.

The world’s largest pharmaceutical firms, on the other hand, have already taken action and are

introducing comprehensive serialization programmes. They know that they need to act early,

because for them the task is enormous. One global manufacturer, for example, will see 75% of its

business covered by the new regulations, and will need to issue and keep track of around 165million

serial numbers a year. (An insight into how this is being achieved is available as a Zenith

Technologies case study).

Other major markets such as the USA, Brazil and Europe are in the process of introducing

requirements:

USA

•The USA intends to adopt Track and Trace (T&T) whereby each carton will get a serial number and the carton will be linked to the case, which will be linked to the pallet and so can be traced throughout the distribution network. No scanning is envisaged at the pharmacy.

Europe

•Europe will adopt Point of Dispense Authentication (PoDA) whereby each carton will get a serial number and that data will be reported to a European-wide database for dispersal to all the official markets where that drug may be dispensed. There will be no traceability through the distribution network until it is scanned and verified at the pharmacy. It is thought that in the future Europe may adopt a combined T&T + PoDA solution.

China

•China has a separate system called E-Code. The Chinese government provides the serial numbers instead of the pharma company generating the numbers themselves. At the time of shipping to market and through the supply chain, details of the status of all good serial numbers need to be uploaded back to the Chinese Government website.

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Schedules, deadlines and even the fundamental requirements of the schemes seem to change on an

almost weekly basis. The basic facts of the situation are clear, however. If pharmaceutical companies

are to continue to develop, manufacture and supply drugs to the market they must comply with the

various new government regulations. The deadlines may be shifting, but companies need to start

working on compliance soon, if not immediately. Certainly, these regulations around track and trace

are likely to be in force in many if not most major markets by 2020 at the latest - and there is little

time to lose.

There are also, of course, significant benefits to be gained from being ahead of the competition.

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The Road Ahead

Assessing the Journey

The Roadmap

The Journey Begins

Part 2: Assessing the Journey

Benefits to Pharmaceutical Firms

The Need to Act

Challenges and Complexities

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Benefits for Pharmaceuticals Firms

Serialization is not something which has been imposed on an unwilling industry. Certainly, the

process presents challenges, and may create additional costs in the short term. But the industry

itself has been instrumental in shaping the new rules, knowing that maintaining confidence in the

drug supply chain benefits all legitimate manufacturers, as does combatting counterfeiting.

Protecting patients against counterfeit drugs is an issue of major concern for all manufacturers.

Serialization will enhance the reputation of the industry and safeguard patients. Enhanced product

authentication and integrity also protects the company’s brands and therefore shareholder value.

Reducing and wherever possible eliminating the ‘grey market’ in counterfeit and diverted drugs

should also help legitimate companies by restoring market share.

Major pharmaceutical companies are focusing their efforts on innovative and smart packaging

solutions that remind patients to take their tablets, combined with packages that enable doctors to

remotely monitor the proper use of the medicine. Smart labels are the next step and serialization

can go hand in hand with these advances.

The process of introducing unique serial numbers will deliver a range of benefits both for individual

companies and the industry as a whole. For one thing, it will provide greatly improved visibility of

the supply chain and control of inventory and logistics across an increasingly global marketplace.

More accurate shipments can cut costs and improve efficiency while the potential for reverse

logistics (which enables companies to improve the management, disposal and reuse of unused or

unsold goods) offers widespread improvements in the handling of product returns and recycling.

The process of serialization will improve workflows and packaging processes as well as the overall

quality of packaging presented to customers.

In countries with single-payer or other centralised health care systems, companies will find it easier

to recoup payment from government agencies tasked with reimbursing drug costs.

Serialization will also deliver better batch and recall control, together with documented evidence on

standards and quality of manufacture. By reducing the likelihood of quality control issues and recalls,

it will ultimately help to reduce costs.

Once the right systems and processes are in place, it will also enable forward thinking companies to

react more rapidly to changes in local regulations worldwide. Most importantly of all, an effective

serialization process will demonstrate compliance with those regulations so that the company can

continue to sell its drugs into the marketplace.

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The following table is taken from an excellent McKinsey and Company report called Strength in

Unity: The Promise of Global Standards in Healthcare <

http://www.mckinsey.com/~/media/mckinsey/dotcom/client_service/operations/pdfs/ops_%20%20

mck%20white%20paper%20global%20standards%20vf.ashx>Pages 48-49.

The table shows the “benefits and required investment for a representative global pharmaceutical

manufacturer - one with 25 packaging lines, annual revenue of $4 billion, and earnings before taxes

or $720 million, or 18% of sales... We assume 70% of revenue is earned in developed markets and

30% in developing markets (used to estimate exposure to high-counterfeit markets).”

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41 Typical "small" recalls - exceptional and large recalls can cost hundreds of millions of dollars or

more

42 Typical range of recalls by pharmaceutical manufacturer, from FDA Gold Sheet 2011

In addition to the need for compliance of product labelling to market specification there are also

both direct cost and indirect end patient health benefits to implementing GS1 GTIN standards.

The report states that by "… adopting global standards in partnership with its trading partners, our

representative pharmaceutical manufacture might expect a range of benefits worth about $43-62

million annually, which represents about 1-1.6% of base revenue and about 6-9% in earnings before

taxes. In addition, a one-time cash flow benefit of about $90 million would accrue due to reduction

in inventory assets."

There are also some non-quantified benefits that derive from applying standards like GS1 GTIN such

as a reduction in medication error due to superior labelling, as well as the accurate, up-to-date and

near real-time information exchange between manufacturers and/or national governance

organisation databases and the hospitals or pharmacies that distribute the products.

The Need to Act

The benefits of serialization are encouraging, offering the potential of a genuine and achievable

return on investment. The fact remains, however, that serialization is not an optional exercise. For

the majority of pharmaceutical manufacturers, it will be a necessity within a few years if it isn’t

already. As we have seen, some companies are already resorting to short-term, temporary fixes that

allow them to continue serving markets where the legislation has come into force. These measures

are inevitably more expensive, and less effective, than a full and proper implementation. They will

not be adequate to continue trading across Europe and the USA, not in the long-term.

Not moving on serialization presents a number of risks to the future of the organisation: there is the

obvious danger of failing to meet regulatory compliance requirements. This could also, of course,

damage the brand. Those companies that can demonstrate early compliance and an eagerness to

embrace serialization will be able to position themselves as forward thinking and providers of high

quality products, keen to protect patients. Lagging behind on this issue could mean falling behind

competitors, who could steal a march in vital global markets.

Ultimately, of course, it could lead to lost sales through the inability to access an increasingly wide

range of markets.

So, serialization is here to stay and all pharmaceutical companies need to act on it - and the sooner

the better.

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Challenges and Complexities

To take action on serialization, your organisation needs to be clear in advance of the challenges and

complexities. There is a reason this hasn’t been done before now: it is hard to achieve and requires

significant changes to existing product lines.

The introduction of serialization is a huge project – one that impacts virtually every part of the

company. It is not simply an engineering or an IT or a carton layout project – it is all of these and

more, impacting all aspects of interaction with the supply chain.

Pharmaceutical manufacturers will need to be able to track what happens to the product throughout

its life cycle, document the entire production process and store this data, ensuring relevant

information can be extracted easily, quickly and cost-effectively. Companies will need to make

improvements to their packaging process, get the whole process right first time to avoid government

fines, and find a way to implement the strategy without incurring excessive costs.

There are significant operational challenges to consider as well - such as avoiding bottlenecks in the

supply chain, and ensuring serialization solutions are scalable so that they can be implemented

across disparate manufacturing facilities and geographies. Network performance will be a major

issue since serialization will inevitably create significant amounts of new data.

There will be many systems involved in the serialization solution and they will all need to ‘talk’ to

each other. Tight and effective integration will be essential. Can the system that generates serial

numbers, for example, communicate with the equipment and software in your product and

packaging lines? Can you pass the information needed on through all your various systems? Will

your database repository of serial numbers deliver up the answers needed rapidly and easily when

regulators come calling? And will you be able to communicate with the systems used in a pharmacy

retail environment? Because one of the visions for serialization, in Europe at least, is that when a

patient receives a drug at a pharmacy, the code can be scanned and the authenticity of the medicine

confirmed. There is little doubt that such capability will delight doctors, pharmacists and patients -

but getting it right will require significant integration of systems.

All of this will require investment, of course. Support and maintenance costs need to be thoroughly

understood alongside the implementation expenses, and built into budgets and forecasts. And then

there is the issue of timings: how long will it take? Will you need to take production lines offline, and

if so for how long? Can you get it finished, tested and ready in time to meet the new regulations as

they come into force? The only way to know for sure is to start thinking and acting on serialization as

soon as possible.

Overcoming and controlling all of these challenges will require thorough planning and a systematic

approach. A roadmap for implementing a solution is contained in the next section.

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The Road Ahead

Assessing the Journey

The Roadmap

The Journey Begins

Part 3: The Roadmap

Requirements of an effective serialization solution

4 Core stages of implementation

14 Steps to success

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Requirements of an Effective Serialization Solution

To meet the new regulations all drug packs will need to include a serialization 2D datamatrix code

typically a machine readable code. If you take Chine is code 128, most other countries are GS1

Datamatrix. Manufacturers will need to maintain a centralised database which links this bar code to

information on the product – which may include such information as when and where the drug was

made, the ingredients used, the machine used, the conditions at the time, which pallet it went into,

where is was stored in the warehouse, when it was shipped and where to, when and where it was

finally sold to a patient.

Essentially, every step in the supply chain must be logged (although in markets that require Point of

Dispense Authentication (PoDA) – where only the packs are serialised and reported – a carton coder

on a packaging line will be sufficient). Local regulators and governments will have the right to

request, store or access the data at any time. (Nothing in the world of serialization is set in stone,

however. In China, for example, the state will control the data, not the companies themselves).

Achieving all of this impacts every area of the business and the project needs to be overseen at a

corporate level. It should also be seen as an opportunity to introduce standardised and modernised

approaches across the organisation. This could include standard processes and ways of working,

training materials and resources, responses to faults, maintenance and support and best practice

generally.

Zenith Technologies has worked with some of the world’s largest pharmaceutical manufacturers,

helping them to meet these challenges. The Zenith Technologies team has implemented fully

integrated Serialized lines that were among the first of their kind in UK, Ireland and Europe. Drawing

on this experience, and our extensive knowledge of the industry we have developed a serialization

approach to help companies implement a solution that is cost-effective, flexible and scalable,

delivered with minimum risk or downtime and which delivers a wide range of business benefits

while also meeting the requirements of the new regulations.

This approach consists of the 14 essential steps, which will take you through the process of

designing, implementing and supporting a world-class serialization solution. Here we present a brief

overview of the 14 steps. (More detailed information is needed to begin work, and is available either

through additional literature or from your Zenith Technologies representative).

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The Four Core Stages of Implementation and 14 Steps to Success

There are four core stages in the implementation process:

ASSESS & DESIGN BUILD DEPLOY SUPPORT

As you will see below, each of these four stages contains a number of steps. There are 14 steps in all,

and by addressing each one thoroughly and carefully, we believe you can begin to take action on

serialization today, with confidence that you will deliver a quality and cost-effective solution that is

right for your organisation now, and will be agile enough to meet your needs for many years to

come.

These steps and stages require input from the highest levels of the business, professional project

management, and the assistance of the right third party suppliers.

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ASSESS & DESIGN

Step 1. Translate Market Regulations and Impact

You will need clarity over the various different requirements of all the markets you serve. It will

make sense to start with those countries that are introducing the new rules early - such as South

Korea, Turkey and Brazil. We recommend a full impact assessment of how the new rules for each

territory will affect your operations. This will allow the implementation team to begin to define the

technical scope of the changes required.

Step 2. Justify the project with KPIs and ROI

The project will incur significant costs and these need to be justified, measured and managed. The

core driver may be compliance to market regulations, making serialization an essential cost of doing

business in specific markets, but the project can also deliver return on investment through greater

visibility of your supply chain, reduction of grey market loses, fewer recalls, and improved product

quality.

Step 3. Carry out independent vendor selection

This is a vital stage and one that will require both time and careful consideration. You need a plan to

generate unique random codes for all of your products (no matter where they are produced) where

you are the market authorisation holder. This may lead you to purchase a third party serialization

solution to generate the random code for each product. Most come from relatively small, specialist

providers. Although these suppliers can be equipment specialist, they often lack the project,

program management and integration experience require to deliver the end-to-end solution across

multiple layers of systems. So you are likely to need a systems integrator as well - and preferably one

with specialist knowledge of the pharmaceuticals industry and of serialization challenges and

processes. You may also need to upgrade and possibly replace your packaging and printing

equipment.

Step 4. Manage Key Stakeholders

Plan for and manage departmental involvement, making sure everyone knows their responsibilities

and the impacts the project could have on their processes and workflows, on their time, budgets and

people. It is vital that the leaders in the organisation are fully aware of the scale and complexity of

the project - which also, of course, needs its own clear leadership structure.

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Step 5. Program Design

This stage involves setting out what the project will look like and how it will operate. This includes

defining: project governance processes; planning around quality, validation and testing; and change,

release and incident management. You will need to identify key stakeholders from each site and

business area that will be impacted by the project and formalise management reporting.

Step 6. Best Practice Architectures

One of the core tasks is to map the current state of your complete supply chain process. The process

is analysed for the impact of serialization and the future state is then also mapped. At this point it

becomes possible to begin to define the scope of the work at hand. The supply chain team needs to

be heavily engaged at this and future stages of the program.

Your vendors may also provide input at this stage. It is likely that many aspects of your business will

have to change. How much it changes should be decided pro-actively by your management teams

and not necessarily lead by one or other of your most prominent vendors.

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BUILD

Step 7. Line Impact Assessments

This step is detailed data gathering exercise about the engineering solutions installed today on your

packaging floors. Together will list of products impacted from Step 1, you can start to list which

packaging lines will be impacted by which regulations, reviewed with technology already installed on

that line, you can start to plan your replacement and or upgrade paths.

Step 8. Serialization Schema

Different markets will require your products to be serialized in different ways. This means that,

coming up with a standard approach to how you will hold the data within your company is not an

easy challenge. It is best to be guided by industry standards in order to insulate your company

against changing market regulations. This approach should provide the most flexibility to adapt to

new regulations that will emerge in the future.

Step 9. Change Management

Change will come from many sources and directions, including: external regulatory changes; internal

changes to scheduling and resources; vendor-driven changes to their offerings; product list changes

(product portfolio / manufacturing lines / site optimisation); and project strategy changes. All of

these changes need to be managed in a way that is easy to view and understand so that the

information can be communicated to the project as a whole.

Step 10. Educational Learning Design and Execution

Who will provide training for the people impacted by the new processes, technologies and ways of

working? It needs to be an organisation with extensive training resources and expertise, but also one

that understands both your industry and the whole issue of serialization. Ideally, it should be one of

the third party suppliers helping you implement the solution. Which ones have training capabilities?

It is something you should consider in Step 3.

Decisions should be made as early as possible about how training will be delivered, who needs it,

and to what extent, and ideally budgets for all of this should feed back into Step 2.

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DEPLOY

Step 11. Standardisation Deployment

If your serialization solution needs to be deployed in more than 2 sites, then a standard approach to

installation, configuration and testing will bring many benefits. These will include more consistent

approaches, reduced testing cycles and a reduction in line / site downtime.

Step 12. Release Management (Rapid Platform Development)

Any solutions you purchase as part of your serialization project are likely to continue to change for at

least the next five years or so. This means that as part of your serialization project, you will need to

make the process of receiving, testing and releasing changes to your manufacturing sites and

enterprise systems as efficient as possible. There will be several release cycles in the early stages of

implementing your project, as your vendors get to know your specific requirements, Each

pharmaceutical manufacturer will have a slightly different setup, so there will be no “off-the-shelf”

solution that can answer all your requirements. As part of Step 3 you will hopefully have selected a

partner who is willing to listen to and act on your requests.

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SUPPORT

13. Managing the Line Impact – OEE

Making changes to your packaging lines, to equipment or to standard operating procedures, will

impact the line efficiency rate. Introducing standard ways of working and creating effective, well

delivered training packs will help reduce the amount of time your line performance is reduced. You

may also find that by introducing standardization, by reviewing line operations and replacing

outdated machines that line efficiency may actually increase.

14. Post Deployment Support

Support of your newly installed serialization solutions needs to be planned from the beginning, and

certainly as part of Step 3 (vendor selection). At Zenith we have found using an integrator to deploy

your solutions also makes them ideal candidates to support the solution long term. Of course that

depends on the integrator chosen.

First line support should be your packaging line personnel who will need the training to fix any day-

to-day issues that arise. Putting in a support structure that captures learning that comes from

support incident and delivers feedback to other sites and parts of the business will start to bring real

benefits to your company.

An experienced knowledgeable second line support team will also be able to help capture and share

learning across the sites, and provide feedback to the project team on where process or technology

improvements need to be made.

Agreeing a support contract with your vendors is also critical to ensuring that long-term issues do

get resolved. It is also important that your company is made aware of any advancements your

vendor is making in their own products. These might impact you in the future, especially if a

technology refresh takes place a number of years after your project team has dispersed, with no one

left who understands how the project was built the first time around.

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The Road Ahead

Assessing the Journey

The Roadmap

The Journey Begins

Part 4: The Journey Begins

How to get started

7 key steps

Taking the first step

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How to Get Started

Serialization will impact the whole business and needs to be overseen at board level. One of the first

questions to ask is whether you possess the expertise and resources in-house to tackle the entirety

of such a huge project by yourself. It is highly likely that you will need outside expertise. Even some

of the world’s biggest pharmaceutical manufacturers came to this conclusion, including a client of

Zenith Technologies.

This client potentially did possess the expertise in-house. But the company needed to implement

serialization across 200 product lines at 20 sites worldwide. The client saw this as an opportunity to

introduce standardisation across all of these sites - and recognised that this was best achieved

through the use of a specialist external provider. This also delivered the added benefits of reduced

risk, cost and downtime.

The right partner will help to walk you through the 14 steps outlined above, making sure you have

considered all the relevant issues and that your strategy and plan is effective and complete.

Based on our extensive experience of delivering serialization in live production environments, these

are our core recommendations:

7 Key Considerations

1. Grasp the benefits of standardisation

If you have multiple sites or product lines, take this opportunity to improve standardisation around

processes, support and ways of working.

2. Create templates

It makes sense not to repeat work unnecessarily. By creating implementation templates, you can roll

out serialization to all your product lines and sites more quickly and cost-effectively, while

minimising downtime. There will always be some customisation required, but this is much easier to

achieve when based on a standardised template.

3. Run a test project

If at all possible, we recommend running a test project in real-world conditions but not on a live

production line. This will test your templates, your processes and assumptions. The lessons learnt

will reduce risk, downtime and implementation time once you move onto the live environments.

This also provides a great test bed for training and can be a showcase to demonstrate to project

stakeholders the complexities of the project and the solutions designed. This test bed can also be

used to test future releases of software from your vendors in a safe environment.

4. Run a pilot

A pilot project takes place on a live production line, ideally following a test project. Again, it is a way

to learn lessons and test everything in a controlled environment before moving on to the wider

rollout.

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5. Train early and often

Before the serialization project is implemented, you need to make sure your people are fully trained.

Some of this training might need to take place before the project even kicks off properly - for your

senior executives and project leaders, for example. Who will provide this training? Do you have the

resources to deliver it in house? If not, then who does possess both the knowledge of

pharmaceuticals and serialization together with the necessary training expertise and resources?

6. Consider support from the outset

Right now, implementation might seem a long way off. It’s tempting the leave the issue of on-going

maintenance and support for another day. We recommend taking it seriously from the start. A

decision over long-term support should influence your choice of service providers from the

beginning.

7. Choose the right partners

When choosing partners for a project of this magnitude and complexity, you should take the time to

ask some serious questions. Such as:

• How well do they know the regulations and requirements?

• Do they understand your production lines and the kinds of components and

technologies already in use?

• Do they have experience of delivering pharmaceutical serialization? Have they done it

before?

• Are they financially stable?

• Are they committed to your industry?

• Can they deliver support and service worldwide - and a rapid response on site when

needed?

• Do they know what it takes to integrate with your current software and hardware?

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Taking the First Step

At Zenith Technologies we are committed to helping pharmaceutical companies of all sizes to

implement effective, flexible and affordable solutions to the challenge of serialization. We have

done it before, working with some of the biggest companies in the world, so we understand the

requirements and have the expertise to help you through the complexities, while reducing risk, cost

and downtime.

Our strengths include:

• Experience in implementing serialization projects

• Expertise at implementing large projects

Knowledge of both the Engineering and IT layers

• Real-world capability and experience in pharmaceutical serialization

• Strong relationships with vendors and partner

• Ability and willingness to offer full life-cycle support

• A comprehensive deployment methodology

• Training expertise and resources

• Ability to provide on-going support.

We hope you have found this white paper to be a useful introduction to the issue of serialization. It

is, of course, only a start and there is more information available both within companion literature

to this white paper (such as case studies and documentation around the 14 steps) as well as from

our experts in person. We look forward to talking to you at greater length about the issues and the

way forward. We also hope we can help you to turn the challenge of serialization into a driver of

significant business benefits, making your organisation leaner, more efficient, more agile and more

profitable.

To get your Serialization journey started or to talk to one of our experts email

info@zenithtechnologies.com today or visit the website to find your local Zenith Technologies office.

www.zenithtechnologies.com/contact-us/