Part I: Actionable Items to Jump-Start your Serialisation Strategy

 

Many companies that are beginning their journey with Serialisation, tend to focus on a bottom-up approach.  They evaluate each line and the requirements for the solution.  As part of this, they may evaluate the overall supply chain network and look at what is being produced and packaged and where each item is being produced while considering adjustments to their network.  However, we advocate for a different approach that is more top-down based.  In this approach, we start at the enterprise level and identify the needs at this level.  Who needs information?  And how will we exchange this information?  The sharing of serialisation data is important for all companies, but the importance of this is amplified when looking at the requirements of Contract Manufacturers or Contract Packagers.  With these companies, the integration to the larger supply chain network tends to be the most critical aspect of the solution, more so than the individual requirements at a line level – especially when their customers and requirements may change at the line level.

Keeping in mind this Top-Down approach, here are 6 Actionable Items to Jump-Start your Serialisation Strategy;

  • Know the Regulations. The biggest mistake is to jump in to the game without knowing all the rules.  Regulatory requirements are extensive, complicated and very different from country to country. Each country/region having their own unique challenges that must be adhered to.  For instance:
    • Aggregation is not explicitly required by the law but to meet the decommissioning requirements found in the law—upon export, and after a cargo theft or delivery truck accident—aggregation will likely be a necessity.
    • The contents of the 2D barcode are specified in the Delegated Regulation, but each EU Member State can specify the all-important “Product Code” data element used within their territory.  That results in unexpected complexity in the definition of the product identifier and the contents of the 2D barcode.
    • The EU is one of the few markets that require the serial number data element to be randomized.  Systech’s serialisation solutions offer the most comprehensive, compliant and flexible randomization capability on the market.
    • The handling of free samples
    • The Delegated Regulation offers an exception for products that are too small to hold the full unique identifier.  Any product that is 10 cm or less when two of its dimensions are summed may contain only the 2D barcode, without the human readable (see the Delegated Regulation for details).

For more information, please review the Systech EU Falsified Medicines Directive Resource Guide. 

  • Identify the Products and Target Market – With serialisation regulatory deadlines around the world quickly approaching, manufacturers are under mounting pressure to meet the minimum requirements of the markets they sell into, or risk distribution in those target markets.   Rather than focusing on what the serialisation solution will provide, typically efforts are concentrated only on meeting deadlines and budgets.  This is where many serialisation projects fail.  The truth is for a serialisation project to be successful, a good set of user requirements are needed to lay the foundation for the stakeholders in your organization and vendors on what functionality is required of the serialisation system to meet the business needs.  Doing a good job with requirements can save your organization from costly rewrite, re-validation, and retraining efforts.

Documenting your business needs is especially critical in regulated environments.  Remember that the user requirements are the basis for the test protocols executed in the qualification of the system. Without documenting your requirements, how can you test them?  The good news is that you do not need a great deal of technical knowledge to specify requirements.  Focus on your products and processes.  By knowing the products and target markets, you can quickly identify critical information such as what package levels need to be serialized, if aggregation is required, where will the serial numbers be sourced from (will the serial numbers be issued by a government agency or will your company create and manage the serial numbers?), and regulatory reporting needs (USA DSCSA, China CFDA, Turkish Ministry of Health, etc.).  By understating your processes, you can easily identify the physical product flow throughout your facility and how the product is packaged.  Both of which are important when implementing a serialisation system whose serialisation data matches the physical movement of the product.

  • Select the Right Serialisation Solution. Compliance with regulations is more than just putting a serial number on a bottle. At the Line level, there are complexities around manual versus automated lines, existing versus new lines, and the varied nature of packaging equipment with the various Original Equipment Manufacturer (OEM) solutions in the industry. At the Site & Enterprise level, the electronic data not only needs to match the physical, but must also be tracked in the supply chain through multiple channels and handle supply chain events like returns, damages, recalls, etc. Serialisation is now a four-level software stack.  Look for vendors that can provide the full range of bottom-up Device and Line-level software as well as integrated top-down Enterprise and Site-level software.  A single-vendor approach to addressing these levels will ensure tight integration of the solution, facilitate data communication, and decrease overall project risk.

Learn more about serialization and the upcoming regulation for Europe’s Falsified Medicines Directive.

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