With a major regulatory deadline approaching this year, pharmaceutical manufacturers across the globe are in varying stages of compliance with the serialization requirements set forth by the Drug Supply Chain Safety Act (DSCSA). With firsthand experience implementing serialization for the largest drug manufacturers in the world, we know that incorporating serialization into your production cycle isn’t a simple flip of the switch – it requires complex, simultaneous work streams across multiple functional areas over a long-term period.
For some organizations, the time, resources, and manpower required to serialize simply haven’t been available. For others, the process is in-flight but perhaps falling behind schedule and thus in danger of missing the regulatory deadline. Regardless, the deadline stands resolute and many organizations are seeking options to mitigate the risk of missing that November target.
With that in mind, I gathered a few of our serialization subject matter experts to develop a list of options to help organizations achieve compliance in time for the DSCSA deadline. Although each step in the list below won’t apply to everyone, these recommendations should be considered in partnership with your serialization integration partner. Getting help from a serialization partner with a proven track record of success is critical at this point in order to mitigate risks to production and profitability while achieving compliance.
Take into account your own strategies, goals, and capabilities to determine the best course of action. Which brings me to step 0 (yes, zero) in the journey to DSCSA compliance.
0. Develop an action plan
No matter who you are or where you are in your journey to compliance – if you think you’re in danger of missing the deadline, an action plan must be the start. Understanding objectives, resources, and current capabilities will dictate your path forward as you consider the options below.
1. Contact the FDA.
If you believe you may be unable or delayed in meeting serialization requirements, maintaining a level of trust with the FDA through clear and open communication is critical. Communicating your course of action and plans for mitigating risks to your compliance will engender a positive working relationship with the FDA.
2. Outsource critical serialization functions.
Outsourcing serialization activities, such as packaging or aggregation, to serialization-capable contract partners allows your organization to maintain a consistent stream of production and achieve compliance. In selecting a partner, it’s crucial that the vendor have both a demonstrative understanding of the relevant regulations and the ability to efficiently exchange information and data with your system(s).
3. Request exemption on a batch by batch basis.
Though this approach has inherent risks and potential impacts to profitability, it may be the best option in certain circumstances. Prioritizing batches based on impact to your business would help minimize some risks.
4. Pre-print offline cartons or labels.
Depending on volume, pre-printing offline cartons or labels could be a strong option for many manufacturers. Small to midsize manufacturers would be best suited for this approach.
5. Use a flex line approach.
For organizations wishing to keep serialization functions in-house, a flex line approach allows you to serialize quickly with minimal disruption to production. With this approach, one packaging line is equipped to serialize non-serialized products from multiple packaging lines. Capable flex lines enable serialization for a range of pre-packed products of varying shapes and sizes.
6. Use standalone systems.
Organizations with basic serialization capabilities can use standalone L3 and L2 systems in conjunction with end-of-line fixed or manual scanning to capture data in a temporary repository. Though a temporary fix, this allows organizations to meet compliance requirements without significant disruption. This also leaves room for the more sophisticated (and time consuming) serialization functions after the deadline.
With the appropriate lead time, developing a serialization solution that both meets regulatory requirements and incorporates additional business is the recommended approach. However, if you’re facing a deadline, now is the time to simplify your strategy and build in the flexibility for additional capabilities down the road. For example, focus on unit level serialization only and leave aggregation for later.
This list may provide your company a range of options for meeting the serialization compliance deadline. Executing any one of these activities requires a significant amount of internal resources impacting your day-to-day business for the next few months. To determine which option may be best for you, learn more by clicking through to our serialization content below or reach out to me using the contact information at the top of the page.