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Stefan Eckert
Home | Newsletter | UPDATE 1 | 2019 | Milestones in serialization
March 4, 2019

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.

 

Ever since, the company has continuously expanded its expertise and service offering in the area of track‐and‐trace. CPO (contract packaging organization) allpack has used the new EU directive (2011/62/EU | Falsified Medicines Directive, FMD for short) on serialization as an opportunity to prepare for current and future industry challenges in collaboration with ARCONDIS.

 

Ready for the future

Pharma 4.0 and advancing digitalization require all those involved along the supply chain to connect their data in order to enable maximum transparency for pharmaceutical goods. Contract manufacturers and packagers especially are facing challenges due to growing requirements from the market and national verification organizations: They have to remain flexible enough to cover the needs of different customers while meeting the individual regulations of different countries, all without negatively impacting overall efficiency. For CPOs, in plain terms this means: The speed of the packaging system itself as well as upstream and downstream GMP processes must also be maintained with serialization and aggregation – after all, this is critical to business success.

allpack considers these challenges not only as a hygiene factor, but as an opportunity for growth and innovation, proactively defining a broad‐reaching “Future Readiness” project to prepare its packaging processes for the future on all levels and ensure compliance, in collaboration with ARCONDIS.

This project focuses on:

  • Implementing a scalable industry manufacturing execution system (level 3)
  • Upstream: introducing a serialization solution that ensures exchange of relevant data with pharmaceutical customers as well as transmission of unique identification information to verification organizations (level 4)
  • Downstream: upgrading existing management software on the packaging line/individual hardware (scanners, printers) at the stations (levels 1 and 2)

Essential to working in the GxP‐regulated environment, qualification and validation activities were considered ahead of time during project planning, as they will see much shorter cycle times in the future.

 

Key success factors during implementation

In addition to technical challenges, the large number of different stakeholders particularly make a project of this scope complex. According to Carsten Franke, ARCONDIS project manager for the allpack project, the following factors were decisive for the smoothest possible implementation:

 

Serialization milestones - Track-and-trace requires unique identification and virtual aggregation for end-to-end monitoring of medicinal products on each packaging level.

Fig. 1: Track‐and‐trace requires unique identification and virtual aggregation for end‐to‐end monitoring of medicinal products on each packaging Level.

Serialization milestones - Information Stack Pharma-Packaging

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.

 


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