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Why Repackagers Need to Kick Off Serialization Projects Now

By April 6, 2016March 16th, 2021DSCSA, Serialization

There are three reasons I advise all my clients to start serialization projects early: 1) The process is always more complicated than it looks, 2) implementation does more than get you compliant – it brings efficiencies to the business that pay off in unimagined ways, and 3) the more dependencies you have, the longer it takes to complete implementation and get compliant. And number three is more true for repackagers than it is for other players in the pharmaceutical market. Here’s why.

As the world-wide healthcare industry grows and reshapes itself, pharmaceutical repackagers play an increasingly important role in improving the efficiency of the drug supply chain and contributing to patient well-being. They also occupy a complicated spot in that supply chain, interacting with a wide variety of partners and customers, from manufacturers and wholesalers, to hospitals, doctors and pharmacies.

Each of those touchpoints have different needs, and operate according to different processes. Which means repackagers will face more complexity when it comes to implementing the Drug Supply Chain Security Act (DSCSA) regulations around serialization. But – if done right – that implementation will also create well-defined processes, better communication channels, and quality assurances improvements.

Serialization Challenges

The DSCSA’s serialization regulations are complicated for every business, no matter where you are in the supply chain. But, based on first-hand experience, I know that repackagers can be especially confused about their responsibilities and how to meet them. Regardless of size, these are the top needs for repacking businesses as they think about serialization:

  • Make better use of limited budgets and ensure the investment is targeted and carefully monitored
  • Identify and train limited internal staffing resources and avoid overburdening employees
  • Create and stick to timelines and strategies for better collaboration and overall execution
  • Work with manufacturers to sort out implementing master data, including Global Trade Identification Number (GTIN) at every packaging level
  • Understand the needs of and communicate with other partners, such as distributors, and create seamless processes
  • Establish a single source of truth for product master data

As I said, these are common to all repackagers. But there will also be challenges unique to every organization. Identifying those early on is critical to a successful and on-time implementation.

Simplify Serialization and Gain Efficiencies with LSPediA

We know that getting an early start on serialization makes resolving issues easier and results in realistic timelines and fewer setbacks. We know because we have managed serialization implementation projects for many manufacturers, repackagers, and distributors. Here’s how you can benefit from working with LSPediA:

  • Lower overall serialization spending by reducing the number of redesigns – the Serialization Toolkit ensures you get it right the first time
  • Mitigate compliance risks and reduce recalls with comprehensive, gapless coverage tailored to your specific needs
  • Ensure your entire organization is equipped, trained, and prepared to implement a serialization process within your company
  • Shorten your project timeline by removing trial-and-error process

The benefits you gain go beyond regulatory compliance to bring about better business outcomes and more efficient business processes. Contact us today to begin the serialization process – we’ll tailor a solution to meet the unique needs of your organization.

 

About LSPediA

LSPediA helps pharmaceutical manufacturers and distributors implement serialization and aggregation processes to meet global regulations, DSCSA requirements, and future track-and-trace mandates. Our services include URS, RFQ, gap analysis, serialization toolkits and solutions, DSCSA strategies, management consulting, and more.

We value long-term relationships and work with our clients’ internal teams to properly define roadmaps, create architectures, and implement systems that align to vital business goals, ultimately helping them derive maximum value from their investments, both now and well into the future.