We know procrastination is a common human tendency. Why do today, the thinking goes, what you can put off until tomorrow? But it’s an impulse that often gets us into trouble – and the pharma industry is not immune. If we didn’t suspect that already, it was verified during the first round of DSCSA implementation in 2014: Manufacturers, wholesalers, and repackagers large and small put off the inevitable until the deadline was staring them in the face.
Why did we do it? It’s not that we didn’t understand the importance of compliance to our business well-being. And there was plenty of outside warning and pressure to get it done. It was not that the importance of compliance was ignored or the pressure get compliance done was not high. Everyone knew they were risking federal penalties and returned shipments if they were deemed noncompliant. I think the reasons were many: Some felt overwhelmed with the process or didn’t know how to get started. Others lacked the resources. And many mistakenly believed that the DSCSA would just go away, or that it was too big a change and it wouldn’t be enforced.
The FDA saw the writing on the wall early and, giving the procrastinators a break, added a five-month extension just before the January 1, 2015 deadline. “Some manufacturers, wholesale distributors, and repackagers,” they said, “may need additional time.” They were being kind, knowing that “some” actually meant “too many”.
Tic Toc – Time to Take Stock
The industry had four years to meet the DSCSA second-phase requirement – serialization. We are now 34 months past the enactment date and 14 months away from the deadline. If you haven’t already, it’s time to ask yourself a question: Is your company ready for serialization? If not, do you have a plan to get there by the deadline?
While I understand the urge, a procrastinator I am not. Something in my DNA has put me on the other end of the spectrum: Call me a pre-crastinator, always aiming to get things done ahead of the deadline. That’s my comfort zone: months ahead of the deadline. As a pharmaceutical consultant with decades of experience, I know all too well what needs to be done before November 2017. So when I walk into a company that’s dragging their heels on serialization, I don’t feel panic – I am calm and my natural task-master nature kicks in. I see roadmaps and resource plans that can help them accomplish their compliance goals. But there’s also a sense of urgency, because there’s not a lot of time to accomplish what needs to be accomplished – 14 months to be exact:
- Packaging line execution
- IT solution deployment
- Warehouse barcode system
- CMO serialization
- Serialized data exchange
- System integration
- And more
What to do Right Now
If that list gives you heartburn, it needn’t. I have deep experience working with companies that have tight schedules and internal hurdles. My only advice: Start now, and you can meet the deadline; start later, and you will set yourself of up for failure and a derailing of the serialization process.
Another thing to keep in mind is that the pharmaceutical industry is partner dependent. Meaning, a CMO’s serialization delay will impact manufacturers, and a manufacture’s delay will impact wholesale distributors.
At this point in time, I am very concerned about those who have not made strides on serialization. I urge you to call me today to discuss how to get this moving. Our goal is serialization compliance, which may require some concessions or extra effort on your part in order to meet the deadline.
How LSPediA Can Help
If your business is at risk due to serialization delays, LSPediA Advisory and Consulting services can help. We offer pharmaceutical manufacturers, CMOs, 3PLs, and distributors large and small a variety of services, including:
- In-depth strategy development and roadmap creation
- Vendor selection and management
- Package line execution
- Technology implementation
- CMO serialization
- 3PL serialization
- Comprehensive project management
Contact me to today to find out how we can provide risk mitigation, independent validation, and oversight for your serialization projects.
LSPediA helps pharmaceutical manufacturers and distributors plan, design, and implement processes and solution to meet serialization global regulations, DSCSA requirements, and future track-and-trace mandates. Our services include serialization gap analysis, strategic planning, solution architecture, vendor selection, line execution, CMO management, supplier management, implementation, 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.