Milestones in serialization How a Swiss pharma CPO meets current and future requirements
allpack – a leading Swiss service provider for pharmaceutical packaging – has specialized in the requirements of pharma companies for 15 years. Active on international markets, the company began relying on country-specific track-and-trace solutions at an early stage: The first medicinal product with a serialized identification code was packaged according to regulatory specifications for the Asian market in 2014.
Fig. 2: Information Stack Pharma-Packaging
- Interdisciplinary project team: Modern packaging integration with track-and-trace requires an end-to-end approach and comprehensive knowledge. At allpack, the process technology expertise, understanding of quality and an affinity for software are combined and concentrated on key people, ideally supplemented by the specific compliance and IT know-how of ARCONDIS. However, most organizations require a larger project team consisting of serialization experts, as well as players from IT, engineering, production and quality assurance, plus packaging designers.
- Creating transparency for customers: The requirements pharmaceutical companies place on CPOs vary greatly in terms of depth and complexity – especially when it comes to identification, data exchange and aggregation. Here, the key to success was integrating allpack business partners in defining the target process and a joint evaluation of process steps early on. Continually involving customers in the monitoring process proved itself very successful, as this ensures a common understanding of the process as well as transparency.
- Supplier selection and management: Experience has shown that legal requirements also attract opportunistic providers to the market that may disappear into thin air later on once projects have been implemented and deadlines met. This makes choosing the right partner and establishing a long-term business relationship extremely important. While selecting suppliers, allpack considered not only hard factors such as functionality, price and integration, but also soft factors: Is the CPO on a par with the supplier? What support is guaranteed during the intensive implementation phase? How established is the supplier in terms of serialization and data aggregation – the core requirements?
Benefits at all levels
The first fundamental project milestone was completed in summer 2018. The result? allpack managed to implement serialized packaging in accordance with the European Falsified Medicines Directive 2011/62/EU far before the deadline in February 2019. Certified to FDA and Swissmedic requirements among others, the company can also already offer its customers innovative custom services, such as aggregation of identification data from folding boxes to bundles, transport boxes all the way to pallets. This change has also paid off in operations: Processes have become more flexible, and ensuring equipment and IT systems complex with GxP requires less effort thanks to a lean framework and reusable, easily customizable templates.
■ Sonja Fix
“Digitalization will bring about major changes for the world of pharmaceuticals”
– an interview with Boris Brunow
After the project is complete, allpack will remain ahead of packaging trends, as Business Development Manager Boris Brunow affirms. He explains the ‘how’ in an interview with UPDATE.
Digitalization will bring about major changes for the world of pharmaceuticals. There are experts for a wide range of disciplines. I can only speak for packaging. I’m sure that the packaging process won’t be turned upside down – until the age of cell and gene therapy dawns on us. In my opinion, the number of blockbusters will go down, and pharmaceutical therapies will become more and more differentiated. For example, customized medicine won’t just be a matter for orphan products. Innovation cycles will definitely get much shorter, and supply chain relationships between long-term strategic partnerships will become significantly more intense and interlinked.
These sound like major changes. How can life sciences service providers like allpack set themselves up for success?
In the future, situational agility will play a key role for small and medium-sized CPOs. Once hygiene requirements have been met, companies should take advantage of market development and “exotic” requests, and work with customers to drive innovation forward. For example, with one customer we implemented a solution for blister serialization with full aggregation to the pallet. Opinion is deeply divided as to whether this makes sense. With anesthetics, or if one day mail-order sale of pharmaceuticals is legalized, end-to-end identification of the supply chain down to the patient can make major added value a reality. I am convinced that once serialization becomes a requirement for prescription medications, this obligation will extend to generics and OTC products.
Business Development Manager, allpack
Further, additional aggregation will become an industry standard in five to seven years. But once again processes will become enormously more complex. Intelligent packaging materials will also become more attractive price-wise in the near future. RFID chips on the primary packaging, for instance, can promptly sync temperature deviations from packaging storage or correct times for taking medicines with the patient file in the cloud via a mobile phone. The degree of automation for classic batch sizes will certainly see an increase, but small batches for late stage packaging must also remain possible. I would go as far to say that commercial and clinical supply platforms will merge or at least have similar structures in the future owing to serialization systems.
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