Contract Pharma talked with Pieter Vercruysse, commercial director at Tjoapack and Geoff Lemin, production support and packaging technology manager for the Wasdell Group about overcoming the challenges of implementing serialization.

Contract Pharma: What are the main considerations when implementing serialization capabilities across packaging lines?

Pieter Vercruysse: One of the biggest considerations when implementing serialization is the scope of your project. Often companies are supplying product to more than one market, meaning there are multiple different regulations that they need to comply with in order to minimise the disruption to supply. Understanding the varying regulations across the global pharmaceutical market can undoubtedly be a challenge and developing a solution that can meet all these requirements can prove complex. The short answer is that there is no one-size-fits-all approach. The key is developing a flexible solution that can be adapted depending on the market for which product is intended. With this in mind, the right expertise and solid foundations, for example suitable hardware and infrastructure to manage serialization data, is absolutely essential.

Geoff Lemin: One of the main decisions that needs to be made is whether to adapt the current packaging lines, either by modification or retrofit, or to install an offline standalone—late-stage customization—serialization solution. Both have their advantages, for example choosing to modify or retrofit existing lines has significant advantages for operational performance. However, this requires significant resource in the planning stages and constant communication between the serialization equipment provider and the original equipment manufacturers (OEM) in order to minimize downtime and return to ‘business as usual.’

In comparison, an offline standalone solution has the advantages of flexibility and will have zero impact on current equipment, it will however, add an additional step into the production process, thus increasing overall cycle time and the amount of space required.

Both solutions will also require additional equipment for data management, facilities modification and materials movement. This in turn will require more space in the facility. All of these things need to be taken into account at the beginning of the process regardless of which path a company chooses.

Contract Pharma: What are the challenges associated with implementing serialization?

Vercruysse: Implementing serialization is a time intensive process. Realistically, this close to the deadline, the only option for companies who have not yet implemented a solution is to outsource their requirements. That being said, it also takes time to engage a contract packager and ensure the onboarding process is done properly to minimize disruptions to supply. As a result, the main challenge from this point forward is going to be finding and enlisting the help of a well-prepared contract packaging organization (CPO) that has the capacity to cater for project requirements. It is vital that companies take the time to find the right partner in order to ensure the implementation process is as seamless as possible.

Lemin: As a contract manufacturing organization (CMO), one of the main challenges of implementing serialization was installing and validating the sophisticated coding and detection equipment required, in addition it was vital to ensure that the software systems we have in place are capable of supporting multiple client and country serialization coding requirements.

We need to be able to deal with multiple client requirements, each with their own SaaS (Software as a Solution) provider, therefore the software provider of a CMO and its clients’ SaaS providers need to work together to ensure that integration is as seamless as possible.

Contract Pharma: What steps can be taken to minimize downtime across packaging lines throughout the implementation process?

Vercruysse: Those who have built in enough time to fully trial and test their solutions will already have identified and combatted many of the potential hurdles that would disrupt continued supply. For those who are not as prepared, enlisting the help of third parties who have the experience and knowledge to advise on the best approaches can be invaluable.

Lemin: We have found that the formation of a cross-function team has been essential for serialization implementation. By enlisting members of the team from across production, planning, packaging technology, facilities, IT, QA and validation from the beginning we were able to safeguard our existing processes and create a solution that worked in harmony with our operations. By setting clearly defined role and responsibilities, milestones and timelines and ensuring bidirectional communication across the business we were able to reduce downtime and develop a focused and efficient approach to implementation.

Contract Pharma: How could serialization requirements impact artwork design?

Vercruysse: Naturally, artwork design will need to be amended to cater for the new regulations. The addition of a 2D matrix alone will require allocated space on packaging and if tamper evidence is required, then this must also be taken into account. Artwork requirements will also vary from market to market and each country’s respective legislative and language requirements will need to be catered for in order to ensure compliance.

Lemin: Serialization will most definitely impact artwork design. Artwork templates for each affected carton profile need to be developed early in the project cycle and the chosen coding and verification system needs be clearly defined, to ensure enough space is allocated for the additional coding requirements for serialization.

The design will also need to take into account the orientation and direction of travel through the serialization equipment when allocating the placement. Developing new artworks for serialization ready components prior to serialization implementation allows inventory reduction, minimises obsolescence and allows for a smoother transition.

Contract Pharma: Have you invested in new equipment to adhere to serialization labelling requirements?

Vercruysse: Tjoapack has a long history of advocating for track and trace in the pharmaceutical supply chain and has first serialized product over a decade ago, as part of an EU research project which we led. So, we have a good understanding of the complexities of implementing this type of process. With the introduction of regulations, we have started with identifying and designing the best and most efficient serialization process for our different lines. It was only then that we selected a software partner and invested in new hardware and equipment that will fit perfectly with our process.

Lemin: The Wasdell Group has made a significant investment in serialization technology to prepare for the implementation of the EU FMD (Falsified Medicines Directive) which comes in to effect in February 2019. The investment includes full aggregation capabilities, meeting additional customer requirements and for non-EU markets such as China and South Korea as well as ensuring we’re well prepared for the 2023 phase of the U.S. DSCSA. For us, the addition of full aggregation capabilities was to ensure our solution was futureproof should aggregation become a requirement in additional markets.

Contract Pharma: How beneficial is it to incorporate aggregation across packaging at this stage? What are the potential drawbacks?

Vercruysse: There are undoubtedly benefits to implementing aggregation now, despite it not yet being the market standard in the U.S. or the EU. In 2023, three-tier aggregation will be a legislative requirement as part of the phased DSCSA roll-out, and following this, it is likely that it will come to all markets. Building a parent-child data relationship across all three levels of packaging from unit dose to pallet allows companies to avoid unpacking entire batches at multiple points throughout its passage through the supply chain, so it’s easy to see why this could reduce time to market.
Added to this, the wholesaler community in the U.S. has repeatedly stated that it needs to be provided with aggregated goods, and that it will not accept the practice of inference, or presumption-based reasoning, as to what a pallet contains. The main reason for this is the problem of saleable returns verification which becomes incredibly time consuming if each pack must be scanned individually. Despite this, many remain reluctant to implement aggregation because of the complexity it adds to the process. In our view, it is a case of ‘when’ rather than ‘if’ this becomes a requirement.

Lemin: For us, introducing aggregation in conjunction with serialization has been highly beneficial as it enables full traceability throughout the supply chain, giving clients full inventory management control and in the unlikely occurrence of an adverse event facilitating an efficient product recall.

In terms of potential drawbacks, adding aggregation to the manufacturing process could have an adverse impact on product timelines as it will add more steps and also make documentation and reporting more complex, with additional data reviews and check requirements for batch release.

Contract Pharma: What do companies need to think about beyond the hardware requirements for serialization?

Vercruysse: The most obvious additional consideration is that of the data collection, management and transfer. Level 4 and 5 systems need to be incredibly robust in order to cater for the huge amounts of sensitive data serialization can generate. Selecting a supplier that can offer a solution to manage this is an important part of the process. Once this system is in place, the relevant process to transfer all this data into storage must be established and tested so that the system’s roll-out can take place as seamlessly as possible and that the validity of the data can be guaranteed. 

Lemin: When it comes to serialization, the hardware is only a small part of a larger service and the software requirements are arguably more important when it comes to the full serialization process. With all of the data, for example product codes and serial numbers, needing to be easily accessed by supply chain partners, the ability for these systems to talk to each other is crucial. The transfer of data, in both directions is the most critical component of the serialization process. As a CMO dealing with multiple clients there is the added complexity of clients using different platforms and all the nuances of individual markets to consider.

Contract Pharma: Are there any long-term, added value benefits that implementing serialization across packaging lines could offer?

Vercruysse: Track and trace systems can also help to streamline operations and logistics. The additional data generated through serialization will inevitably drive the industry to utilize electronic data exchange systems and cloud platforms and increase visibility of the supply chain as a result. By granting access to an increased amount of legacy data through serialization initiatives, companies will be able to make strategic improvements to their operations such as streamlining order forecasting. Increasing the visibility of stock levels and improving access to shipment data will also lead to more accurate demand planning and hopefully reduce waste across the supply chain.

Lemin: Serialization is a mandatory regulatory requirement as per EU FMD and as such, if we want to continue supplying the EU market provisions must be made to support it. The only other alternative would be to outsource serialization requirements to a third party, which in itself would present additional challenges. Performing serialization internally puts us in a position to support markets where serialization and aggregation are already a regulatory requirement and prepare for those markets, such as Russia, which are due to implement serialization in the near future.