Clarkston Consulting
Skip to content

Serialization & Manufacturing Expansion

When a company’s ability to compete depends on the speed at which products can be supplied to the market, opening a new manufacturing site can be highly advantageous. By embedding serialization requirements into their expansion strategy, pharmaceutical and biotech companies will not only ensure compliance, but can also capitalize on additional business benefits across their global supply chain.

Tighter product control can reduce counterfeiting and diverted product, and can also improve a company’s reputation, yielding greater revenue share. Additionally, increased supply chain control and visibility can lead to more accurate planning and shipments, and more efficient recall processes in case of adverse events.

Companies should consider the following when aiming to optimize serialization implementations at their manufacturing sites.

Start now.

  • Companies have much to gain by implementing track and trace systems early. Many underestimate the amount of time it will take to fully configure and validate the new system, so it is critical to start as soon as possible. If your company is looking to expand, you will also have to consider integration with legacy systems and a sustainability strategy.
  • Implementing this system will also require planning to analyze and adapt the system to achieve brand protection, anti-counterfeiting, and verification/authentication solutions. Companies need to make sure they consider the time it takes to test, roll out, and prove their systems and processes are compliant with both serialization and traceability requirements, and FDA 21 CFR Part 11 requirements.

Perform a comprehensive business analysis.

  • Since every business is unique, there is no one way to implement this system without customization. Analysis of your processes, materials, equipment, and local regulations will be essential, in addition to aligning your current systems with the new serialization solution to avoid duplicate work. The key question will be how to integrate the technology with existing operations, especially packaging across manufacturing facilities, the supply chain, and existing systems (such as warehouse management or ERP systems).

Choose a scalable technology.

  • The technology matters. The solution and design need to be standards-based, scalable, and should allow for future requirements, since global regulations are still evolving. A scalable system will be able to support distributed operations across a manufacturing facility, distribution center, warehouse, and dispersed geographies.

Have a flexible project strategy.

  • Global templates are often times the best strategy. Develop a corporate standard and then provide local guidelines to allow for adaptations to regional legislation.
  • Gather global design requirements from all regions to generate a template that can easily be rolled out in an adaptive manner, requiring mostly master data set up and minor configuration.
  • A flexible base will allow your company to grow, while having a central strategy and system. This will also allow for controlled verification of the solution, and will enable successful validation and migration to the production environment.

The overall solution will need to include: serialization (or track and trace) systems to create, detect, and manage serial numbers; pedigree management solutions to create, communicate, and manage drug pedigrees electronically; and integration services to tie these systems with their existing IT infrastructures.

Essentially, to achieve speed and agility in implementing serialization solutions, you’ll need company-specific programs that incorporate the principles discussed above. Improvement efforts must be supported by analytical models that highlight the impacts of the change to the supply chain. And seamless execution will be dependent on a highly-skilled team of supply chain professionals who routinely assess and adjust all dimensions of the extended supply chain.

Tags: Serialization & Traceability, Supply Chain Technology