As a pharmaceutical company, your first and most important task is to implement your serialization infrastructure. Within the next three to five years, the vast majority of your product volumes will be serialized, so selecting a solution that truly meets all of your supply chain needs is imperative. Here are three current trends that will drive decision-making processes for pharmaceutical companies and their solution strategies.
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 40 percent to 50 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 wholesaler operations that they also engage in, their requirements under the law were different than they initially assumed. What are your commercial agreements with partners, how might they change over time, and how does that impact your compliance?
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 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, picked, shipped, received, quality released, recalled, damaged, and expired. If this manufacturer packs 24 items per case and 120 cases per pallet, or a total of 5,208,333 cases and 43,403 pallets, the yield of serial numbers commissioned annually is 130,251,736, all of which must be individually addressable and available for audit purposes.
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 are managing this scale of data and transactions?
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 mission critical are serialization capabilities and processes for you? Would you be comfortable building, maintaining, or even hosting your serialization infrastructure in-house?
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 packaging, or the information you need to exchange with supply chain partners or submit to a regulatory agency. If you ship product to China, Brazil and Europe, for instance, you are looking at three different primary serial number formats: a government-issued 20-digit EDMC code for China; a non-GS1, manufacturer-issued 13-digit code for Brazil; and a GS1-compliant GTIN manufacturer-issued code for the European Union. All three of these situations have different requirements around how information is exchanged, also, from China’s manual file upload and download system; to Brazil’s XML integration between the manufacturer, ANVISA, and throughout the entire supply chain; to Europe’s integrated data exchange between stakeholders and the hub and national systems. And then you may have to consider the different requirements for Turkey, Argentina, South Korea and more.
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 needs to be able to meet diverse market requirements. Your solutions partner should be one step ahead of you as additional countries announce new and unique requirements, and also contractually commit to keep you compliant with evolving requirements in whatever countries you’re currently doing business.
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.
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