The Life Sciences Supply Chain and Serialization: Three Emerging Trends
Also published on SupplyChainBrain.com.
With the January 1 U.S. Drug Supply Chain Security Act (DSCSA) lot-level traceability deadline now behind us, many pharmaceutical companies are turning their attention to full drug serialization. DSCSA requires that manufacturers mark packages with a product identifier, serial number, lot number, and expiration date by 2017. In that period, highly regulated packaging and distribution processes must be changed; physical equipment must be procured and operationalized; enterprise-wide IT must be implemented, and end-to-end serialization testing with supply chain partners must take place well in advance of the deadline to allow time for any necessary adjustments. Given these multi-faceted complexities, three years is an aggressive implementation timeframe.
As a pharmaceutical company, your first and most important task
Trend #1: The scale and scope of producing products and moving them through the supply chain network is becoming increasingly complex
Serialization brings big changes to an industry that is already navigating more diverse production and partner relationships. The first thing you need to understand is the flow of your product through the global supply chain. These days, many companies are forty to fifty percent virtual. How many internal packaging lines do you have, and how many contract packagers do you work with? Do you have any customers for whom you manage the packaging? All in all, how are you going to integrate this diverse network of processes and participants?
You also need to be fully aware of your own business processes. During lot level traceability implementation, some manufacturers realized that due to
When serialization takes effect, your ability to connect with partners and track all of your different operational requirements will be more critical than ever. You need to select data management architecture that will help you collaborate with all external parties given their disparate technical capabilities, data formatting choices, roles within the supply chain, and relationships with you. Which solutions offer a platform that allows you to seamlessly exchange serialization data and streamline communications?
Trend #2: Data and transaction volumes are growing exponentially
Serialization will introduce a massive new volume of data, and with that comes storage and processing challenges. Most companies have not sat down and calculated the exact volumes they’ll be managing, but that’s an essential step. How much product do you generate? How many units do you ship each year? What is the total number of serial numbers that you will need to create on an ongoing basis? How many events against those serial numbers will you need to track and store? Keep in mind that you’ll need to be able to do that at scale, in real time, in conjunction with all of your other your operational processes. For many companies, the end result is billions of records – and terabytes of data -- that will need to be retained and available in a retrievable state for up to twelve years.
Consider a pharmaceutical manufacturer that packages 125 million items annually. For each item, a range of serial number management events – generated, reserved, commissioned, decommissioned, destroyed – need to be tracked. In addition, other operational events must be tracked, such as packed/repacked,
From there, each serial number will have approximately 5 events a year for an annual event total of 651,258,681 events. The manufacturer will need to keep the records for twelve years – seven years past the average expiry of five years. In a steady state, that equates to 1,563,020,833 serial numbers and 7,815,104,167 events.With each event at 1KB per number, the annual serialization repository growth is 651 gigabytes a year, with a steady state serialization repository of 7.815 terabytes.
Data storage is much more affordable than it used to be, so cost isn’t the primary issue. Rather, companies need to look at the scalability of storage associated with their serialization solution. Does the system enable hardware capacity expansion as serial number creation grows and existing numbers still need to be retained? Performance is the other considerable challenge.All of the file exchange transactions require a lot of computer processing capability and your serialization solution must have adequate read/write throughput and easily scale in performance to keep up with transactional demands.Well in advance, you’ll need to put it to the test by processing a high volume of daily transactions, so you can be sure that its capabilities meet your specific volume requirements. What systems are you running today that
On another technical note, ask yourself how much redundancy your company is comfortable with and how much downtime it can tolerate, keeping in mind that you cannot sell your product into countries in which you are not compliant. How
Trend #3: The global footprint of the pharmaceutical industry continues to expand
Almost all companies in today’s supply chain operate globally, so DSCSA requirements are not the only ones they will need to master in the next three to five years. The European Union, China, Brazil, and South Korea are just a handful of the countries implementing new regulations.
To add to the complexity, no two countries have the same requirements, whether it is for the serial number that you place on the primary and secondary
What countries is your company doing business in, and how is that likely to change in coming years? Assuming that you are operating globally, the major mind shift that needs to occur is moving away from local solutions to thinking on a global enterprise level. The platform and architecture you select for serialization
Serialization will bring a greater level of security to the life sciences supply chain, a benefit that is ultimately passed on to patients.For pharmaceutical companies, though, the unavoidable truth is that it will impact many aspects of your operations. The most important step you can take to achieve both compliance and minimal business disruption is to select the right solution.
If your business is following the same trends as the larger industry, your production network is increasingly complex, your data storage and processing needs will expand, and your global requirements are growing. Ask the right questions of potential providers. Find a system that is built to negotiate a complex supply chain, is scalable, and is flexible enough to meet your needs both in 2017 and beyond.