Most Pharma companies have been taking a “wait and see” approach to starting a Serialization and Traceability initiative, hoping that the bill to reauthorize the Prescription Drug User Fee Act (PDUFA) would contain provisions for Track and Trace that would delay implementation of the California ePedigree law. The bill that Congress recently passed did not include provisions for track and trace requirements.
Unfortunately – or Fortunately
Depending on how you look at it – it looks like the California ePedigree law will go into effect in 2015. This is an unfortunate outcome for those companies hoping to delay complying with California law. A fortunate outcome though, from a patient safety perspective, is that the pharmaceutical supply chain will be secured sooner rather than later. So what does this mean for the Life Sciences industry? For those companies that already have some type of serialization program underway, this validates their strategy and puts them in a great position to comply with the California ePedigree law. However, those companies that have taken a “wait and see” approach will have to quickly assess and develop a strategy to implement serialization and traceability solution.
With the luxury of time, organizations can take a methodical, phased approach that ensures the various dynamics (i.e., business processes, trading partner relationships, systems, engineering, etc.) are understood and tightly integrated to provide a closed loop system. As companies continue to procrastinate, they will not have this luxury and will be forced to implement solutions using a big bang approach that significantly increase costs, while introducing great risk to the organization. The path to a fully developed serialization and traceability solution should be executed in manageable chunks.
The following are major steps along that path:
- Assessment and Roadmap – Developing a solid roadmap that supports a phased approach to implementing a serialization and traceability solution is the single most important step for a successful implementation. The roadmap development requires assessing the company’s existing facilities and packaging lines for capital investment, developing the business requirements, selecting the appropriate hardware and software, and developing the total program costs and schedules. Finally, the strategy/roadmap needs approval from the company’s senior management.
- Serialization Pilot – Piloting the serialization solution on a single packaging line allows the organization to drive out lessons learned that can then be leveraged for an enterprise wide roll-out. The pilot entails executing a proof of concept for serialization, engineering trials that exercise end to end scenarios, validation testing, and taking the total solution live to production. This pilot may include Track &Trace component or this component could follow the packing line pilot.
- Roll-Out Strategy – Once the lessons learned have been digested, a roll-out strategy must be developed. The strategy will determine if the roll-out will be done line by line with in a plant, by product, by region, etc.
- ePedigree Implementation – Selecting the appropriate solution that meets the ePedigree requirement is the final step in a complete serialization and traceability solution. The ePedigree solution will leverage the information created in the previous phases.
So, the time to wait is over and a well-defined strategy will greatly benefit a company’s ability to successfully implement a serialization and traceability solution. Failure to do so will result in increased costs and risk.