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Revisiting the Global Serialization Landscape

by Michael Kinsella
Thought Leadership

Serialization continues to be one of the most pressing issues in the industry. Following an internationally recognized mandate to implement a system of track and trace into the supply chain, countries established their own best practices to ensure compliance on national levels. However, these differing regulatory requirements have created confusion in the industry on an international scale. Countries have been pressured to change their operations and bring on staff with new areas of expertise in order to meet specific standards within a short period of time.

 

An International Approach to Serialization

The need to serialize is changing the way business is conducted throughout the supply chain. That countries are not aligned in their serialization requirements globally has only further muddied an already complex situation. For example, in Russia, the government plans to have full control over sales unit traceability throughout the supply chain. If a pharmaceutical manufacturer wants to produce and commercialize a finished drug product, they have to request government crypto codes before production begins and then complete up to 60 data transactions, from production line to dispensing activities, through a government database. This is a very different model from the European Union, where an end-to-end model is implemented. In this model, serial numbers are coded onto the sales units by the manufacturing organization and eventually decoded upon dispensing. A definitive feature of this end-to-end model is that the reporting demands during transport are less rigorous (unlike in Russia). In Russia, the model of full control also extends beyond pharmaceuticals to all commercialized goods, including alcohol, tobacco, cosmetics and luxury items.

The different traceability requirements globally also reflect a varied range of motivations in implementing these systems. Preventing counterfeit products and circumventing fraud might be the main motivator for one country, while preventing over-reimbursement is the primary concern for another. The approach to serialization and how the process is overseen differs from one country to the next, including which organization is tasked with ensuring manufacturer compliance. In the United States, the Food and Drug Administration must confirm whether companies comply with serial requirements; in the EU, serialization oversight is monitored by health authorities from each member state, and, in Russia, the Ministry of Trade tracks compliance directly.

In addition to the different driving motivations, regulatory agencies, oversight committees and available technology and resources in serialization, in Europe, certain countries have accepted a short grace period for serialization, where companies will not be fined if they have not achieved full compliance, while other countries, such as Germany, Poland and Austria, have a much stricter position today when it comes to enforcement.

Companies may now have to upgrade or reinvest to comply with a series of evolving international standards and solutions. Interestingly, in Europe, not all manufacturing organizations are currently connected to a European manufacturing hub. It may take several more months to get all remaining manufacturers on-boarded with the EU hub. Solutions deployed in Europe will not fully meet the Russian crypto coding requirements, and some companies may have to completely revisit (or at least upgrade) their capabilities to remain compliant.

 


As a major player in the global supply chain and a leader in serialization, Servier has the expertise and resources required to help our global customers meet track-and-trace requirements in all markets


 

Addressing a Hesitation to Serialize

In Europe particularly, a lack of early communication and training support for all stakeholders involved has penalized the readiness across the pharmaceutical supply chain. National enforcement of serialization has varied significantly, with some countries intending to implement fines and others taking stricter or laxer approaches.

Becoming compliant with serialization involves multiple steps, including checking data, ensuring printing quality, an absence of duplicates and connecting an interface with existing systems. For some companies, changing systems where there is a lack of expert staff or appropriate resources in place can represent a great risk, especially considering the consequences from an investment and process perspective.

In order for serialization efforts to be successful, a learning period is a must for companies to build and fully master the new processes and solutions, which are integrated into their operations. Most countries, including the United States and Turkey, have introduced a phased approach to traceability to allow for actors to build their maturity step by step. However, the EU mandated compliance on a single date, which represents an ambitious target for all actors involved.

The expansion of serialization requirements down to the unit dose level is likely to be met with even greater resistance than the original global sales unitmandate. Among other reasons, this is because packaging lines are mostly not equipped with unit dose serialization functionality. Serialization at the unit dose level would pose considerable challenges without major investment from the industry. Serialization of secondary packaging, while adding the additional unit dose serialization level, requires fundamental changes and investment across operations. Servier has already begun pilots on unit dose printing for lot and expiry.

Even though serialization solutions are fully validated, roles and responsibilities will have to adapt to manage these solutions — for example, a line operator/technician with a mechanical background will need to be well trained on the software.

 

Servier’s Global Advantage

As a major player in the global supply chain and a leader in serialization, Servier has the expertise and resources required to help our global customers meet track-and-trace requirements in all markets. Servier is present in a total of 148 different countries. This large-scale global exposure has made us aware that a singular solution for multiple markets is impossible, which pushed us to take a modular approach to serialization, developing a core system that is an aggregate of the requirements of different countries.

 


Even when an organization inputs good data, attention is necessary throughout the process to get good data out.


 

A Connected Industry and the Promise of Serialization

The ultimate benefit of serialization is that it will make the industry significantly more connected. Serialization allowscompanies like Servier to understand who all of our partners in the supply chain are — and where they are. It gives companies the opportunity to centralize information to ensure the visibility of product flow in the supply chain and the transfer of ownership.

Serialization carried out correctly allows for endless possibilities. It forces companies to reflect on the interconnectedness of processes and systems while empowering the end user. At Servier, our production facilities are becoming more connected because of serialization, which could lead to real-time tracking of product management and supply chain activities. This can be a very powerful tool if companies execute the process correctly, but it can also be a Pandora’s box — you are no longer selling only physical boxes, you are also selling data — and this data is a new company asset. Unfortunately, many organizations do not have this kind of expertise to rely on and, as the industry becomes more digitized, will have to build this skill set into their operations with strategic training and hiring.

Almost all of our clients rely on Servier’s expertise and guidance in serialization, as very few have superior systems at maturity. We are also working with small CDMOs encountering track and trace for the first time, who do not fully understand what is required and rely on us to provide guidance.

Our clients’ demands and strengths shift depending on the size of their organizations. Small companies can be quite agile and responsive, while larger organizations naturally tend to have more constraints to take into account. Our approach to dealing with both is to meet the standard minimum requirements first, build a relationship and take it step by step. Each of our client projects is handled on a case-by-case basis.

 

Good Data In and Good Data Out

When dealing with the abundance of data that is a by-product of serialization, a strong security network is an ultimate priority. At Servier, we address data security before anything else and implement multiple controls to ensure that a breach is never a possibility. In addition to our automatic interfaces, we use complementary manual checking processes to verify the authenticity of data on initial data loading. Our primary focus is having the appropriate data in our system, which means ensuring that the data entered at the source is correct and having total oversight over all updates. Systems are now connected production to distribution, and, in Europe, we keep a record of all transactions.

With serialization, each organization is more and more connected. The key is managing the interface and ensuring data management, security and integrity in all transactions. Even when an organization inputs good data, attention is necessary throughout the process to get good data out.

 

Building a Network Through Serialization

An interconnected industry reinforces the value of the Internet of Things (IoT),which has become a reality in the pharmaceutical industry. At Servier, we are building a network through serialization that provides solutions and opportunities. A comprehensive network was absent in the industry, but, as a result of serialization, real-time tracking could become the standard — which means real-time communication with our stakeholders. The continuity of this network is also critical for patients.

Servier has taken a proactive approach to serialization and is working to educate our clients at every phase of the process. We have developed e-learning tools, including webinars and videos. Perhaps most importantly, we pay special attention to the human elements of the new processes. For example, an employee focused on packaging compliance now has to be aware of data interfaces, data exchange and data coding. This is very much an end-to-end process, and changing one part of the process has an impact on upstream and downstream activities and individuals. For serialization implementation to be successful, managing the people within the process is key.

 


Servier has taken a proactive approach to serialization and is working to educate our clients at every phase of the process.


 

Revisiting the Global Serialization Landscape

Serialization continues to be one of the most pressing issues in the industry. Following an internationally recognized mandate to implement a system of track and trace into the supply chain, countries established their own best practices to ensure compliance on national levels. However, these differing regulatory requirements have created confusion in the industry on an international scale. Countries have been pressured to change their operations and bring on staff with new areas of expertise in order to meet specific standards within a short period of time.

Aligning the Outsourcing Relationship

As outsourcing to pharmaceutical contract service providers increases, aligning the goals of sponsors and suppliers has become increasingly important. Servier, through its contract manufacturing division, is responding to this market demand by prioritizing strategic partnerships, our service offering, quality and compliance.

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