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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
[email protected] today or visit the website to find your local Zenith Technologies office.
www.zenithtechnologies.com/contact-us/