For pharmaceutical manufacturers, business challenges don’t arrive one at a time. Instead, your to-do list grows and fluctuates on a daily basis: You and your staff are in a constant battle to maintain scientific productivity, meet customer expectations, manage compliance, iron out supply chain wrinkles—and the list goes on. Serialization is on that list, too (hopefully near the top). But for most small- to mid-sized companies, the process and needs around serialization can seem like maze – if not a downright mystery. Many organizations forge ahead anyway, hoping that, in the end, the pieces come together into a cohesive – and compliant – whole.
Hope, as they say, is not a strategy. The Drug Supply Chain and Security Act (DSCSA) due dates are approaching fast, and ad hoc serialization strategies will undermine your company’s compliance standing and reputation, and put your business at risk.
Serialization: Easy to Understand, Hard to Achieve
I consult with a wide variety of companies, and each has its own unique challenges when it comes to serialization. But I also see many businesses making similar missteps. Which isn’t surprising, because serialization is a complex undertaking and organizations often lack the specific skills and insight required for headache-free implementation. What are most companies getting wrong? Here are the most common mistakes I see:
- Focusing efforts on packaging operations, causing gaps in supply chain, quality, and IT
- Master data, including Global Trade Item Number (GTIN), that doesn’t meet local market requirements, causing compliance issues, and even recalls
- Selected software solutions that can’t be implemented or validated, resulting in redesigns, major compromises, and wasted time and resources
- Partners that underperform or aren’t prepared, which undermines integration efforts, as well as timelines and budgets
- Underestimating training needs, leaving employees uninformed about the process, unprepared for their assigned tasks, and frustrated in their roles
And of course there are other pitfalls, too – incomplete gap analyses, poorly managed CMO relationships, technology oversights – but with proper planning and experience, all of these are avoidable.
Simplify Serialization, With the LSPediA Toolkit
Our Toolkit is providing businesses like yours – in manufacturing, distribution, and repackaging – with a simplified way to meet DSCSA serialization regulations. We ensure you achieve your goals on time and on budget, while maintaining complete control over the process. This is how you could benefit by working with LSPediA:
- Proper training for every stakeholder in every line of business
- Dedicated project management to keep all entities informed and on task
- Lower overall spending by ensuring you get serialization right the first time
- Mitigated compliance risks and reduced recalls with comprehensive, gapless coverage
- Shortened project timelines by removing trial-and-error process
Contact me today, and let’s discuss how we can customize a Toolkit that fits your organization’s needs.
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.