With just months to go until the EU FMD and DSCSA deadlines, Marketing Authorisation Holders (MAHs) / manufactures yet to implement serialization programs need to think strategically and collaboratively with expert partners. Choosing a partner with global reach, and a proven ability to implement full-service serialization programs not only ensures rapid and effective deployment, but also improves business outcomes and lowers supply chain costs.
Preparing for regulatory compliance requirements means implementing good technology that assures data integrity, connectivity and integration, as well as partnering with the right solution provider to get you over the finish line and benefit in the process.
The current landscape
Despite the sounding of the alarm, a large number of companies have not yet established the infrastructure and processes required to meet serialization compliance requirements. While it’s not unusual for some organizations to lag behind due to time and costs, it’s easy to underestimate the complexity of adding serialization capabilities to operations. However, savvy organizations and early adopters have caught on to the benefits of implementing robust serialization programs, and have used new regulatory compliance requirements to catapult their organizations into a new level of supply chain productivity. Done well, serialization adds four orders of magnitude to supply chain visibility, giving pharma companies the opportunity to increase value for themselves as well as provide value to stakeholders involved in a drug’s journey from bench to bedside.
The serialization process requires an understanding of all products distributed, and a mechanism for identifying and ensuring the good standing of all parties through the supply chain. It’s therefore vital that pharmaceutical companies have a full understanding of the laws, but once those components are well understood, designing and implementing a serialization program enables visibility, collaboration and agile workflow across a broad end-to-end process.
With a good serialization solution and collaborative business partners, pharma companies can benefit from real-time analytics of performance across their partner network. How many units have been manufactured? How many shipped? Were there any issues? Moreover, companies can access intelligence on reverse logistics, enjoying full visibility of returns from wholesalers or dispenser and the reasons for them. Such visibility can also help with complex pricing or diversion challenges.
It isn’t easy to implement serialization programs that meet regulatory requirements and extract value. The former is ebbing away and the latter takes time; however, industry knowledge and expertise will not only get you to go-live via the shortest, safest route, but also set your organization up to experience the added value of such programs.
Naturally, technology is an integral part of the solution, but serialization should not be divorced from the founding principle of Good Manufacturing Practice (GMP) – quality. Serialization and traceability also require aligning processes and software to generate, capture, share and affix data related to products’ unique identifiers (UIs). This data must be accessible to downstream trading partners in order for them to receive, ship, authenticate and dispense products. If the data isn’t in the system – or it isn’t accurate or reliable – there are implications for both profitability and patient care. Quality data and effective data management is therefore crucial.
Urgency, Consistency and Planning in Implementation
The opportunity of serialization technology and the data it can unlock is only half the story. To realize its true value, the other critical factor speed-to-market. In the current environment, time is not only sensitive; it is urgent.
Regulatory compliance is undeniably the primary driver for the deployment of serialization solutions. However, serialization software must provide significant value beyond compliance. The best systems will be those that focus on data validation and integration to create a single version of the truth for stakeholders across the supply chain. Moreover, they’ll provide full end-to-end visibility to help drug companies – and all their partners – improve operational efficiency, increase profitability and give patients safe, timely access to authentic medicines.
The deadlines for FMD and DSCSA compliance are rapidly approaching and companies that have not yet prepared for serialization need to move quickly and urgently, but with care, precision, and a plan to extract value from their compliance investment.