Requirements for serialization are already active in some parts of the world and will soon be obligatory in the U.S. and Europe. Pharmaceutical manufacturers face the daunting task of updating their processes and systems in time for the 2017 and 2019 deadlines.

With multiple production lines to manage, variances in regulations across different geographies and the need to implement a solution that can be adapted to future track and trace requirements, serious thought needs to be given to the serialization challenge. This article will review the current track and trace landscape and describe a best practice approach to planning a serialization project.

The situation
The serialization of licensed drug products will be a legal requirement in the U.S. from November 2017 in line with the U.S. Drug Supply Chain Security Act (DSCSA). The EU rules will then follow in early 2019, with guidelines set out in the EU Falsified Medicines Directive (EUFMD) Safety Features Delegated Regulation.

Serialization entails adding a unique identifier to single saleable units of prescription, and some other medicines, so they can be tracked and authenticated at different stages in the supply chain. The challenge expands far beyond the packaging line and will impact all corners of the industry, ranging from pharmaceutical manufacturing through to dispensary.

A series of incidents involving counterfeit medicines have led to a move towards serialization to ensure patient health and safety. The World Health Organization (WHO) estimates that the problem of falsified medicines accounts for between seven and 15 percent of all medicines circulated in developed countries, while the challenge is on a larger scale in the developing world, accounting for 30 to 40 percent.

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 reputation of well-established manufacturers. While the legal requirement for serialization aims to eliminate falsified medicines, there is a huge task ahead for pharmaceutical manufacturers in the U.S. and Europe who must now adapt their processes and systems to ensure compliance.

Planning a serialization project
While the majority of big pharma companies have their deployment activities well underway, there are a huge number of smaller and mid-sized pharmaceutical and biotechnology product manufacturers that still need to take their first step on their serialization journey.

The introduction of serialization is a huge project that requires careful planning. A pharmaceutical manufacturer may have multiple manufacturing lines, in multiple locations, with more than 75 percent of its business needing to comply with the new regulations. There are therefore a number of factors to consider.

Geographic complexities
Serialization regulations are currently in place in Turkey, Argentina, Saudi Arabia, China, South Korea and India, while the EU, U.S. and Brazil are in the deployment stages, with formal regulations set to be introduced.

While major markets are aligned in their view of the importance of serialization, the specific requirements and philosophies behind the regulations can vary significantly from country to country and even state to state.

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 (T&T) and the ability to associate cartons with cases so that products can be traced throughout the distribution network.

In Europe, however, the focus is on authenticating drugs at the point where they are dispensed to patients, known as Point of Dispense Authentication (PoDA). There will be no traceability throughout the distribution network until the product is scanned and verified at the pharmacy.

The confusing patchwork of rules with no overarching regulatory framework requires a flexible serialization solution that can be adapted to different requirements. A full impact assessment of how the new rules for each territory, including the EU and U.S., will affect operations must be performed before embarking on a project.

Operational challenges
There are significant operational challenges that must be considered 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.

It’s important to map out the current state of your complete supply chain process and how this will need to change to incorporate serialization. This will make it possible to define the scope of the work at hand. The supply chain team needs to be heavily engaged and your vendors may also provide input.

Organizational challenges
Perhaps the biggest challenge is the need to face a process that will impact all departments within an organization. Many companies think mainly about the effect on their production lines, which are only one part of the serialization process. In addition to production, serialization will impact the warehouse, IT, quality assurance (QA) and enterprise resource planning (ERP) functions, to name just a few. It’s important to remember that the successful installation of serialization software and hardware is just one element. For example, it will also be necessary for pharma operators to get used to completely different procedures and processes at line level.

Technical challenges
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? And will you be able to communicate with the systems used in a pharmacy retail environment?

It’s important to perform a line impact assessment and gather information on the engineering solutions installed on your packaging floors. This will help you to plan your replacement or upgrade paths if required.

Timelines and potential downtime
Timing for the new requirements are tight. Perhaps the biggest misconception surrounding serialization is that processes can be implemented simply and quickly. Experience from recent projects suggests that a minimum of one year is required to implement a full serialization line that can run with good overall equipment effectiveness (OEE).

It’s important to map out how long the whole process will take within your organization. Will you need to take production lines offline? If so, will this impact product supply and how can this be minimized? Can you get your solution completed, tested and ready in time to meet the new regulations? The only way to know for sure is to start thinking and acting on serialization as soon as possible.

With 15 months until the U.S. deadline and less than three years until the introduction of EU regulations, companies need to act now or risk being late. A particular area for concern is the purchasing of packaging machinery. No original equipment manufacturer (OEM) on the market could expect to experience such a peak in machine demand and deliveries are therefore going to take longer and longer.

Financial investment
The project will no doubt incur significant costs and these need to be justified, measured and managed to create a solid business case for the changes. The key driver may be the need to comply with regulations in order to do business in specific markets, but the project can also deliver return on investment through greater supply chain visibility, reduction of grey market losses, fewer recalls and improved product quality.

Software selection
Considering that your production activities will depend on the reliable functioning of your serialization solution, there is tremendous pressure on software providers to get things right. Software that is not robust and reliable or a supplier that cannot provide quick support places a manufacturing plant at risk of downtime. For this reason, while important, cost should not be the only factor when sourcing a software solution.

It’s important to assess the financial stability of your provider and whether they have a solid business continuity plan in place. Verify their track record and the timing of previous installations. Also, consider how many lines they have installed in the past year versus resources involved. Suppliers with a higher rate of line engineers should be your preferred choice as it means they can perform installation quickly and smoothly, with no hidden costs. It could also be worthwhile to verify if any clients have switched from one supplier to another, as despite the high costs involved, this can occur when companies are disappointed by performance.

As the market is in a continuous state of change, choose a software that allows easy installation of additional functions without impacting on the validation work already performed. Selecting a solution that is developed 100 percent internally also means that modifications can be easily performed without depending on external factors. It is important to remember that when there is an issue with your serialization processes, in most cases, your production will need to stop. As a result, the more knowledge your provider possesses about the software and pharmaceutical procedures, the more quickly issues can be resolved.

The software provider you choose should have a strong partnership and levels of integration with the OEM. Ask them for a proven implementation record including timelines so that you can determine whether the implementation, installation and validation time is in line with equivalent projects and if the supplier followed the planned schedule. While many providers try to reassure customers using their number of available engineers, what is critical is whether they have experience working on such complicated projects.

Finally, be wary of suppliers that make everything sound easy; serialization isn’t easy at all, but can be smartly implemented with the right partner.

Communication and responsibilities
Many departments will be involved with the serialization project and it’s important that they understand their responsibilities and the impact the project could have on their processes and workflows, time, budgets and people. As well as having a dedicated taskforce to drive the project forward, it is vital that the leaders in the organization are fully aware of the scale and complexity of the task ahead.

Change will come from many sources and directions, including external regulatory changes, internal changes to scheduling and resources, vendor-driven changes to their offerings and product portfolio changes within a manufacturing site. All of these changes need to be prepared for and communicated to all who may be affected. Only then can they be managed with minimal impact to product supply and production.

Training will also be essential. Make sure you know who will provide training to those impacted by the new processes, technologies and ways of working. Third party suppliers can help you to implement serialization solutions, as well as delivering training and ongoing local level support. Consider which of the potential vendors have training capabilities when selecting your hardware and software providers.

Consider the future
Track and trace requirements are likely to keep evolving, with regulations in various markets moving in different directions and at their own pace. At present, the industry is waiting for a Brazilian regulatory review and soon Russian and Mexican guidelines will arrive.

The future could bring many more challenges. In time, every pocket on a blister pack may need its own serial code. One day, companies may even add chemical markers to a drug as a further means of identification.

While current requirements for serialization bring a number of challenges, they also create an opportunity to innovate and improve. For example, major pharmaceutical companies are focusing their efforts on innovative and smart packaging solutions that remind patients to take their tablets. Packaging is also being considered that would enable doctors to remotely monitor the proper use of medicines. Smart labels are the next step and serialization can go hand in hand with these advances. CP

References

1. World Health Organization, http://www.who.int/en/

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David Sheedy is a product manager at Zenith Technologies and is responsible for defining and developing product strategies. David joined the company in 2001 and has worked in many roles including serialization IT deployment. Having worked within the life science industry for 15 years, David is an expert in pharmaceutical processes, with a particular focus on serialization. He also has a wealth of knowledge in systems integration, automation and distributed control systems (DCS).

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.