Seek an Independent Minded Partner on DSCSA
Keep Your DSCSA Partners Independent Minded
As the industry understands the impact of the DSCSA stabalization period recently announced by FDA. We continue to march toward the most challenging parts of DSCSA and new challenges and technologies continue to emerge, the number of factors to consider in making decisions can become unmanageable. For pharma manufacturers and pharmacies this can be especially true as time and energy is often more focused on the critical tasks like managing new regulations, submitting applications and navigating through an incredibly complex US pharma financial system.
Most would quickly see the need for experienced partners in understanding new demands, meeting requirements, staying up to date on changes, revised FDA guidance and other industry standards. We encourage clients to seek insights from any partner, which can include software partners, 3PLs and new hires with experience. As the saying goes for the investor minded “Buy the truth and don’t sell it”. With all the new laws, guidance, standards, systems, impacts by segment and technologies, it is best to assume that it is impossible to be fully informed.
As with most advice, there is always a need for a healthy bit of perspective and skepticism. Carefully consider the experience and perspective of the source as they may be limited in ways that will lead to future difficulties. There is lots of information in the market ,some of it is proving to be good, some of it is looking bad and a good share is too early to tell until the full impacts of Covid 19 are understood, 2023 DSCSA interoperability and beyond plays out.
Here are a few things to keep in mind when deciding on systems and partners needed to meet current and future requirements while also keeping the path open to gain value beyond compliance for patients, customers and your company:
- Seek multiple perspectives. While a trusted partner from any service area should be invaluable, you should assume they may not have full perspectives and confirm their thoughts around key decisions or insights. A partner that will be performing your contract packaging may feel they can fully cover your serialization data needs globally but may not be considering events and requirements downstream. As an example, if you find after product launch that you quickly need to stand up a second contract packager for spikes in demand, you may find it difficult to then manage multiple serialization data pools or competitive spirited integration.
- Pay attention to experience. Partners who will be performing services for your company should bring similar experience that can be valuable. How many solutions have they implemented that are in similar markets? Do they have experience with similar needs? How far are they in meeting current and future regulations and how many clients do they have that are testing or preparing for the next wave of requirements?
- Solve current compliance with future compliance and business needs in mind. There are a significant number of unknowns with DSCSA and other laws but there are always many “likely to happen” and several “possible to happen”. While the approach of meeting the minimum requirements and short term cost control is understandable, it could actually cost significantly more and limit future value. While the expense of systems and equipment is delayed, many find later the overall spend is significantly higher due the need to re-implement changes at all sites.
- Consider growth into other markets. Laws vary in significant ways around the world and many partners are limited in which markets they can support. It is important to look at which markets are possible to grow into in the next 3-5 years and consider what the path would look like when making key decisions. For example, while a US based 3PL may be able to more quickly and cost effectively meet US DSCSA labeling, tracking or data storage requirements, will they be able to support your future markets? Do they have experience in those markets and added requirements like government reporting, aggregation and resources that manage/monitor changes in each country? In what ways might this limit your ability to make partner changes or additions in this area in the future?
As supply chain consultants with serialization experience, we feel it is critical that we provide independent perspectives and experiences across the entire supply chain from packaging to dispensing. Whether you bring on a new hire with experience or seek a contract based consultant, understand what reseller relationships or experiences they have, and make sure their experiences are coupled with independent perspectives. When a partner from any segment of your supply chain offers a service that might be perceived to add value beyond their segment, don’t miss an opportunity for optimization but test the assumptions and look for blind spots with help from independent minded.
While it is understandable that many pharma manufacturers and pharmacies would decide to lean on their partners for digitization advice and solutions, it is important to make sure you take a step back and ensure key decisions make sense from an overall supply chain perspective. Look to connect and keep in touch with your peers who are also working to implement these compliance requirements and are sharing their lessons learned. The only certainty over the next years is that there will continue to be uncertainty until regulators, industry stakeholders and systems can fully gather and align on the unfolding challenges and interoperability requirements. We welcome your comments and questions and look forward to seeing the Pharma industry evolve towards a more digital and secure supply chain.
About Ten Count Consulting:
Ten Count Consulting is a Pharma focused management consulting firm specializing in Digitization, DSCSA Audit Readiness, Serialization Systems, and Value Beyond Compliance. We are subject matter experts in US DSCSA requirements. We Have Over 75 Years of Collective Experience in Project Management and Supply Chain Systems & Innovations.