Selecting the right serialization partner 1

Your essential guide to selecting the right serialization partner

Selecting the right serialization partner 2

Introduction

Today, for most pharmaceutical companies it is becoming increasingly complex to stay up-to-date and compliant with the evolving requirements and guidance surrounding anti-counterfeiting regulations. With fast-approaching deadlines and a need to achieve compliance quickly, companies must consider the impact on productivity from poor serialization implementation.

With demand at an all-time high in the serialization market and an ever-growing pool of solution providers eager to support pharmaceutical companies, it is critical that companies establish who the trusted partners are within the industry, and determine which organizations have the complex skills and capabilities to guide them towards the best possible implementation program.

This eBook has been designed as a guide to selecting a serialization partner, for those pharmaceutical companies that are starting out on the process to selecting a track-and-trace solution provider. It will provide an overview of the challenges associated with counterfeit medicines and the regulations which are being put in place globally to safeguard supply chains and patients. By considering the points outlined, pharmaceutical companies will gain an understanding of the primary factors in selecting a robust, all-inclusive solution that reduces overall risks, timelines and costs.

Selecting the right serialization partner 3

The complexities of counterfeit medicines in the pharmaceutical market

The global pharmaceutical industry faces many challenges associated with the prevalence of counterfeit medicines. The result of which includes loss of revenue for pharmaceutical companies, not to mention the risks to patient safety that are synonymous with taking uncontrolled or fake drugs.

In the developed world, the World Health Organization (WHO) estimates that counterfeit drugs account for approximately 1% of the supply. Although this may seem like a relatively small figure, it consists of millions of prescriptions across the US and Europe alone. In developing countries, the percentage is significantly higher at between 30-40%.

The global fight against counterfeits

More than 55 countries have introduced mandatory serialization and track-and-trace measures to fight against falsified and counterfeited medicine in the market. Argentina, Brazil, China, India, Korea, Turkey and the US have already released local regulations with defined implementation timelines. Europe, Saudi Arabia and the Ukraine are also in the process of establishing and introducing their own regulations over the coming years.

Each nation will follow its own guidelines with their own unique characteristics, meaning there is no standardized approach for pharmaceutical companies to follow – this makes exporting goods highly challenging. As waiting on a future worldwide standard is not an option, it is essential to choose a serialization partner that can help to manage the complexities across the varying geographies and one that is already experienced in the global impact of the regulations.

Selecting the right serialization partner 4

What to consider when choosing a serialization providerOn the surface, choosing a serialization partner may appear to be a relatively simple selection process, however there are many different considerations to make. Below are four key questions to ask during the review process:

1. How does the solution provider rate in terms of technical know-how?

From a technical perspective, the implementation of a serialized line might not appear too difficult. Indeed, most companies may be used to working with cameras and view it as a relatively simple project. However, cameras are only the tip of the serialization iceberg. An implementation project has a much wider impact across all aspects of a pharmaceutical company, including procurement, production, IT, warehouse, sales and, of course, an organization’s workforce.

For a serialization solution to be effective it needs to interface with a pharmaceutical company’s enterprise resource planning (ERP), manufacturing execution system (MES), machinery and programmable logic controller (PLC) systems. For an inexperienced provider, it is very easy to become overly focused on minor issues that experienced serialization providers have already solved successfully several times over.

2. Is the solution simple, flexible and future proof?

In the ever-evolving legislative climate it is essential that pharmaceutical companies select a standardized, flexible and simple solution that can work with all serialization requirements across the globe. It is also important that additional functionality and capabilities can be readily added without the requirement to revalidate the entire system. This will allow the solution to be easily upgraded or adapted in line with on-going regulatory changes and developments. Working with a scalable system will allow pharmaceutical companies to simply update their system whenever a new regulation arrives or an existing one changes.

It is advisable that in most cases companies avoid the temptations of using small local serialization providers, which at first glance may seem to offer an attractive package in terms of cost and timings. These types of companies are less likely to offer the necessary global expertise in terms of regulatory knowledge and the ability to establish sufficient support programs on a worldwide scale.

Selecting the right serialization partner 5

Continued...

Marketing

Does the solution provider have a solid track-record of success?

Given the multiple technical and logistical challenges associated with implementing a solution, reputable providers should be able to demonstrate a concrete track-record of working across the development of varying serialization architectures. An understanding of how complex the process can be across differing markets is vital. It is also important to ascertain that the provider recognizes that regulations are liable to change. A provider which demonstrates proactive planning for any future developments is essential.

Where possible ask for case studies and references of experience, as well as examples of the outcomes achieved. It would also be advisable to gather evidence that the provider understands how to design, source and commission both the hardware and software technologies required to implement various serialization capabilities.

Is the solution tried and tested?

A reputable partner should be able to demonstrate that its solution has been tried and tested. After considerable planning, a pilot line should be introduced to demonstrate and test the solution against a pharmaceutical company’s needs. This pilot phase will allow the provider to overcome any hurdles prior to product manufacture, resulting in fewer issues and rejections when the solution is fully rolled-out.

Reflecting on the experience of many large pharmaceutical companies, going from a pilot program to implementing a fully optimized serialization solution, it can take a year before a company arrives at the same production rate as before the solution was implemented – and this is if the right partner is selected.

Selecting the right serialization partner 6

Implementing a serialization solution

There are two primary areas that are affected when it comes to implementing a serialization solution; the packaging lines and the integration of software with existing systems.

For this reason, it is essential to choose a partner that can bring experience in both machine integration and software development.

It is important to note that interfacing with machine PLCs is completely different to interfacing with ERP, SAP and supply chain software providers. A reputable partner will have teams with experience in both fields.

An ideal serialization partner should also be experienced in working collaboratively with original equipment manufacturers (OEMs) of packaging machines.

In an ideal situation, the serialization provider and machine manufacturer should work in partnership to develop the best possible integration of the system inside the machine logic.

A cooperative partnership ensures the best chance of achieving a safe integrated solution, which minimizes the manual rework intervention on the line. Less rework means higher productivity, reduced costs and a much higher level of safety.

Selecting the right serialization partner 7

Potential pitfalls to be aware of when selecting a solution provider

While trust is obviously a huge element of any working partnership, there are several red flags which all pharmaceutical companies should be privy to as they navigate the pathway to identifying a suitable partner.

Machine integration is non negotiable

Focus on serialization as core business

Watch out for technology modifications

Be cautious with companies that claim they do not need machine integration because they manage serialization with their own parallel logic: this kind of solution, even if in some cases they are cheaper, provides a high risk of uncontrolled events on the line. In this case the pharmaceutical company is obliged to fix all solution inefficiency with standard operating procedures (SoP) and this will depend on the individual capabilities & responsibilities of the operator..

Many companies label themselves as machine manufacturers. While it’s easy to modify a technology which a company itself has created, it is not as easy to modify another company’s solution. No reliable large packaging line manufacturer will ever modify a competitor’s machine. They will only ever modify a solution that they know well – their own product!

Every company has its own expertise. When looking to implement a serialization solution pharmaceutical companies will likely reap the best rewards by selecting a company that is a specialist in the field. If companies are competent and successful in their core business, they don’t need to add other service offerings into their portfolio.

Selecting the right serialization partner 8

Pitfalls continued...

Don’t be blindsided by turnover

Evaluate the capabilities of the ‘real team’

Be wary of inadequate support material

In response to the growing regulations, smaller serialization providers have grown fast in terms of turnover. Turnover should not be evaluated in isolation as a means of success. Steady growth, a proven install base and appropriate after sales support are all much better measures of a reputable company to work with.

If there is an issue within the serialization process and nobody to solve it quickly, a line will not be able to produce and downtime could ensue. This potential cost needs to be considered during the process of selecting a partner. A line stoppage is not worthwhile, so it is important to do your research and avoid suppliers that have negative support feedback in the market.

Finally, in some circumstances, particularly where takeovers have occurred, it is important to ensure that the original team is still working for the solution provider. Sometimes experienced teams move on leaving skills gaps. Ask for the background and experience of every key team member that you will be working with.

Making the first move

Implementing serialization is a complex process for even the most dynamic and change adept pharmaceutical companies. Selecting the right partner for the journey will be key. While companies are today left with no choice but to implement a serialization solution, for busy organizations who are finding themselves under greater pressure to comply with varying regulations in short timeframes, the selection of a capable provider may seem like an overwhelming task. Using this guidance as a check list in identifying a solution and provider will not only help protect your brand but also generate the most value for your organization.

Selecting the right serialization partner 9

Top Tips Five steps to success

Have you already started implementing your serialization strategy?

Here’s our five steps to success.

0102

0304

05

Be forward-thinking

The likelihood is that as serialization becomes the ‘norm’ in the pharmaceutical industry, regulatory bodies will identify ways to make anti-counterfeiting measures even more robust. So, consider how your serialization solution will stand up to changes in regulation. Ensuring you have a flexible solution from the outset will make it easier to adapt as legislation evolves over time.

Market requirements

Many pharmaceutical manufacturers will supply to multiple markets in a number of geographic locations, all of which have slightly different track and trace compliance laws. Again, the flexibility of your solution is key. Get to know the varying market requirements and consider whether your solution can adapt to them all.

Build in time to test your solution

On paper your serialization strategy may appear robust, but there’s no substitute for rigorous testing. Testing your solution out on a pilot line will allow you to identify potential hurdles before they arise and avoid costly downtime, loss of business in key markets, product wastage and even supply shortages.

Ensure your staff are ready for the challenge

Integrating serialization into your supply chain should extend beyond the hardware and software requirements. With so many facets of serialization to consider it’s important that your entire team understand their role in compliance and how your solution will affect every part of your organisation. Investing time in training your staff will be invaluable when it comes to overcoming problems and avoiding unnecessary expense.

It’s not too late to consider support

Serialization is a complex process and even if you’ve already started to develop a strategy, bringing in external expertise can help to speed up your journey and simplify the integration of new technologies. Don’t take a short-term view. While the end goal of achieving compliance before the US and EU deadlines is important, a robust support model should be in place for the long term.

Selecting the right serialization partner 10

Contact

Carlos Machado is serialization director at Zenith Technologies and is responsible for sales, operations, implementation and post project support services in the US and Canada. As part of the serialization initiatives, Carlos is leading the partnership between Zenith Technologies and Sea Vision implementing its serialization product suite, focusing on speed to deliver, engineering excellence and a superior customer experience.

In his previous role as director of operations at a leading anti-counterfeiting technology provider, Carlos helped to pioneer the serialization concept and define the future of authentication.

He has a wealth of experience in assisting pharmaceutical manufacturers with track and trace technologies and has worked on more than 75 serialization projects, from both an operations and delivery perspective.

Marco Baietti is commercial director at SEA Vision with responsibility for technical sales and advising pharmaceutical and biotechnology clients globally on the introduction of serialization software.

With 20 years’ experience in technical sales, Marco has the ability to understand clients’ complex challenges and find a solution to meet their needs. Before joining SEA Vision, Marco worked for a number of leading global companies in packaging machinery. Marco has a BA in Electronic Engineering, Management Information Systems and Services.

Carlos MachadoSerialization DirectorZenith Technologies

Marco BaiettiCommercial DirectorSEA Vision

SEA Vision+39 0382 529576mbaietti@seavision.itwww.seavision-usa.com

Zenith Technologies+1 61 02 34 32 42carlos.machado@zenithtechnologies.comwww.zenithtechnologies.com

Follow us Follow us

Selecting the right serialization partner 11

SEA Vision+39 0382 529576info@seavision.itwww.seavision-usa.com

Zenith Technologies+1 61 02 34 32 42info@zenithtechnologies.comwww.zenithtechnologies.com