Pharmaceutical Validation: Five expert views on Track and Trace

European Pharmaceutical Review’s roundtable devoted to track and trace technology. Five industry experts focus on how the contribution of track and trace technology is shaping the pharmaceutical sector and explain what factors are driving that change.

What are the key elements of a successful track and trace system for the pharmaceutical sector?

ETTORE CUCCETTI, CEO, ACG Inspection: For the successful implementation of a pharmaceutical serialisation system, understanding of the packaging process, country-specific regulations, in-depth knowledge of process compliance and, most importantly, the right implementation partner are crucial. Implementation partners must possess skills such as project management expertise, service and maintenance capability, and financial stability. Also, as these projects are more of a software deployments scenario ranging from medium- to large-size scope, then system validation, security, handling and maintenance of large quantities of data is critical to the business.

Selection of lean architecture-based software solutions along with modular hardware design is a must, not only to drive changes in current packaging processes, but also to accommodate future complex additional – or amendments to – regulations in the process.

Pharmaceutical companies also need to consider minimal disruption to existing processes and its impact on productivity, to successfully reap the benefits from the serialisation system.

WILLIAM MINAEFF, SR Project Director, Adents: As a serialisation project progresses, there are many challenges that need to be faced and many sources of complexity. Serialisation failures most frequently come from not understanding the scope of a serialisation project. For example: not identifying all stakeholders and their requirements, regarding packaging, label change, supply chain, IT and enterprise resource planning.

There are five key elements of a successful track and trace serialisation solution for the pharmaceutical sector, which are:

Configurability; meaning no specific development needed, with easy updates and upgrades management, allowing for virtually no chance of human error
Scalability; meaning when the initial rollout phase is achieved, you can smoothly deploy serialisation on additional lines without repeating the whole process
Interoperability; meaning increased flexibility to choose the hardware that best fits your objectives, and uses any of your existing equipment when valuable for serialisation and minimises costs and delays in delivery
Site level management capabilities; meaning the most secured and efficient approach to cope with change management. Having a centralised single point from where you can manage all your configuration and processes will help facilitate configuration management, data exchange, reporting, change management and validation support as well as IT governance. Site level management capability minimises risks and helps prepare you to meet future track and trace challenges.

DR STEFAN OEING, Head of track and trace software department, Atlantic Zeiser Ltd: Beside powerful HW units, which can flexibly handle different packaging formats on all levels in combination with serialisation and track and trace coding (aggregation), the overall SW-System itself will become increasingly important. On Level 2 (Line Management), the SW solution must be able to communicate in real time to all involved HW-units and provide an accurate picture of the commissioning process. This also covers any kind of manual rework necessary during commissioning. After completing batch production, balancing of data must be possible between all physical units (moved into stock), and all data sent to Level 3 software (site manager). Afterwards, post-lot processes must be accurately managed through pre-defined workflows, covering the generation of all regulated reports, the assembling of any shipment, and the reporting to any higher level SW (internally or externally, Level 4 and Level 5). Finally, the interaction with a (national) database will assure that the status of each code is up-to-date and available for all relevant participants of the track and trace process.

YANIK BEAULIEU, Technology Leader, Optel Group: The key elements of a successful track and trace system are three-fold. First, the flexibility to interact with multiple third-party IT systems (ERP/ MES, EPCIS server, government instances, etc). Second, the reliability and ease of use to minimally impact productivity. Third, adaptability through consistency: every packaging line is different, yet constancy between all lines / equipment is important for users.

JOE LIPARI, Director of Cloud Products, Systech International: A successful track and trace system requires flexibility to meet the unique connectivity needs of your supply chain. All systems are not created equal, but all systems in pharma are validated. Having a track and trace system capable of interfacing with a myriad of systems requiring varying data and messaging standards is key to successfully integrating the supply chain.

What benefits do such systems deliver to industry and the consumers they serve?

ETTORE CUCCETTI: Implementation of a serialisation system will be beneficial across the pharmaceutical value chain right from the marketing authorisation holder (MAH) and contract manufacturing organisation (CMO), to the supply chain partner, pharmacies and end-consumer. The pharmaceutical companies will be benefited with advanced capabilities to improve the supply chain and data security between different stakeholders. A track and trace system helps to monitor and control the counterfeiting issue and ensures brand protection.

DR STEFAN OEING: Such systems fulfil legal requirements, which aim to protect the consumers against counterfeiting. But they can do much more; for example, monitor packaging systems as well as internal and external logistics processes. Based on this, processes can be optimised, and components with best vs. worst performance and/ or quality can be identified. This can take place in different locations, eg, at the pharmaceutical manufacturer or along the legal supply chain. The overall picture can also provide valuable market information for different regions. Serialisation and track and trace codes can also be used to establish direct communication to the consumer, which opens the door for generating customer loyalty and gaining valuable customer insight.

YANIK BEAULIEU: The main goal is obviously to secure the supply chain against the counterfeit product for the end user, but brand protection is also a significant benefit. Many other benefits could be named, such as minimising the impact of recalls, logistics and handling advantages during production/distribution. This leads to interesting avenues in the future. Those include stock shortage prevention, cold chain distribution control or the end user having access to more information about the product in their possession, including advertising and health recommendations.

JOE LIPARI: In a word, visibility. The holy grail of track and trace is having full transparency into where a product has been. The value this delivers to a consumer is the confidence that the product you or your loved ones are consuming is from a trusted source.

How has the importance of track and trace systems changed over the past 10 years?

ETTORE CUCCETTI: We have seen a major transformation in the perspective of customers over past decade – from meeting the mandates to utilising master data for the betterment of production planning and supply chain management.

Today, the implementation is not only limited to printing on cartons but also includes data management and data security.

The industry is now looking towards single source solution providers that help them through compliance adherence, creating significant value addition to business and consumer safety.

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