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Home | Newsletter | UPDATE 1 | 2018 | Serialization of medicinal products
February 26, 2018

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 is intended to counteract falsified medicines, thereby ensuring patient safety and the reputation of the pharmaceutical industry. This may sound easy in theory – printing a number code on medication packaging – but in reality, it is a complex undertaking, as different code systems, serialization formats and aggregation level requirements must be complied with depending on the production and export country. Serialization numbers in China are issued by the authorities, while companies in the EU and U.S. generate these themselves. Since the FMD only stipulates verification at the end of the supply chain as well as risk-based verification of intermediaries, the FDA requires the medicine to be tracked for each individual change in ownership. The FMD is not a harmonized policy, but rather an umbrella that bundles regulations and requirements from different participating states that also allows individual adaptations per country.

 

Serialization of medicinal products - counteract falsified medicines & ensuring patient safety

 

The fundamental principles for verifying medicinal products in the EU are:

 

  • Safety measures: Medicinal products must have a unique identifier with a randomized serial number. The authenticity of the packaging must be verified at the delivery point.
  • System design: The EU allows for flexibility in implementing national solutions within a technical framework (as per user requirements specification). The compatibility between different national systems to the European hub must be ensured.
  • Data privacy: Transaction data belongs to the stakeholder generating it (e.g. the pharmacy — sales data). Other stakeholders shall not have access to this data except for verification purposes.
  • Governance: Adherence to guidelines is monitored by the EU and/or national authorities. Quality monitoring is ensured by the European Directorate for the Quality of Medicines (EDQM).

 

Serialization of medicinal products - Serialization in a nutshell

 

This results in the following three key challenges that apply universally to all regulations within and outside of the EU:

 

  • Label redesign: Often, packaging does not have enough space for the new 2D barcode and must be completely redesigned.
  • Production efficiency: The labeling requirements have a number of effects on the entire packaging process. This requires more resources and in certain circumstances a higher degree of automation.
  • Data management: The IT infrastructure must be set up to store an enormous volume of serialized data during the legal retention period (in Switzerland, ten years) and to communicate across different systems in real time.

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.

 

Serialization of medicinal products - costs of serialization

 

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

 

Serialization of medicinal products - Implementation of Serialization Requirements

Implementation of Serialization Requirements (click the image to enlarge)

 


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