Serialization of medicinal products counteract falsified medicines & ensuring patient safety
The Falsified Medicines Directive (FMD) will take effect in February 2019. This gives companies in the EU, Switzerland and other participating European countries just under a year to implement the requirements for serializing medicinal products. In the US, similar requirements became obligatory in November 2017 with the US Drug Supply Chain Security Act (DSCSA) coming into force; many other countries have also implemented serialization.
Serialization — Mastering challenges
Many pharmaceutical companies that are currently implementing or initiating serialization projects, are confronted with major obstacles. ARCONDIS accompanies different customers through the process; on this basis, we have compiled the typical pitfalls related to implementing serialization requirements and show how to master these challenges.
- Gradual implementation: The ideal serialization solution is standardized, modular and covers all aspects of internal business processes, data exchange as well as reporting and assessment requirements. Implementing such a complex project under enormous time pressure – after all, there are only just under twelve months until the FMD deadline is up – is a challenge in itself. This is why implementation in phases is recommended, taking into consideration the specific deadlines for different geographical reasons. It is important not only to prioritize individual requirements based on these deadlines, but also to establish an overview of all country‐specific directives before considering detailed planning in order to identify possible synergies by simultaneously implementing similar requirements.
- Central project management: Synergies are created at a global level with a harmonized solution. It enables flexible and optimized resource planning and therefore a faster and more efficient roll‐out. In practice however, central project management cannot always be realized. In such a case, the best alternative is using a central platform for “lessons learned” to share experiences, selectively collaborate on improvements and to thereby deliver synergies.
- Stakeholder management: Oftentimes, companies lack understanding as to why printing a code is so important and what benefits serialization brings to the table. To ensure the involvement of all relevant stakeholders, it is important to establish awareness not only of the effects, but also of the additional benefits of serialization right from the start. Stakeholder management should not be a side task, but an active force in a broad campaign.
- Supplier management: Not only companies, but also their suppliers, service providers and business partners often lack an overall understanding of the correct interpretation of statutory requirements and their practical implementation. For this reason, it is not enough to simply pass along a list of requirements – intensive, active supplier management should be made a priority and all process interfaces compared in order to not only establish a comprehensive understanding of requirements, but also to harness synergies.
- Interdisciplinary team: Serialization imposes requirements and affects all areas of the supply chain, thereby not only requiring an enormous amount of time, but also specialized knowledge. This is why ideally an interdisciplinary team consisting of not only serialization experts, but also representatives from IT, engineering, production, quality assurance, packaging designers and sales staff is necessary.
- Overarching policy governance: Varying needs from different departments often result in nonhomogeneous application landscapes and master data sets must be managed in multiple systems. But serialization requires an end‐to‐end solution. Complete verification and documentation of all interfaces is essential. Furthermore, introducing a standardized data lifecycle management system with comprehensive policy governance is also recommended to create a homogenous IT environment with streamlined master data sets.
Obligatory serialization entails costs as well as expenditures for both internal and external resources and the IT infrastructure. If implemented intelligently, a standardized, centralized solution can bring about overall more efficient data maintenance and an optimized cost structure. Clearly defined and implemented policy governance and a modular infrastructure above all creates a sustainable solution that can be easily extended for new products, suppliers and customers.
■ Ferdinand Burger, Carsten Franke