Pharmaceutical Serialization and Implementation Myths
Take a hard look at the pharmaceutical industry and its packaging processes. Does anyone sincerely doubt that a serialized future is bearing down on the industry? The pharmaceutical packaging process has changed, and the serialization tipping point is approaching.
In theory, pharmaceutical serialization is fairly straightforward. Individual products need to be tracked through the supply chain and, when necessary, traced back to their origin. To achieve this visibility, manufacturers need to apply a unique identifying code to each product on a unit-level basis. The codes then need to be communicated among trading partners and relayed down the supply chain.
But as the clamor surrounding looming serialization mandates grows louder, it’s become increasingly difficult to separate fact from fiction. As the industry takes action it’s time to separate reality from myth..
Myth 1: I Can Wait to Serialize
Consider three important reasons why every pharmaceutical manufacturer should serialize now:
1) California and international regulations are taking effect
2) Serialization vendors have limited resource capacity to meet the impending demand surge
3) Manufacturers can exploit the ROI benefits and competitive advantages inherent in unit-level tracking.
The California e-pedigree mandate, slated to go into effect on January 1, 2015, remains the de facto national law, despite lobbying efforts to delay or dilute regulation at the federal level. This legislation is fueling track and trace discussions in the United States partly because California represents a tenth of the nation’s prescription drug market. And to meet this challenge, manufacturers need to serialize all of their prescription drug lines, not just a subset for California, because their distribution channels (rather than the
manufacturers themselves) determine the final destination of each product.
The U.S. is not alone in this: Turkey, China and the European Union, among other governmental bodies, have forged ahead with their own pharmaceutical regulations. Forward-thinking manufacturers will need to develop smarter packaging lines to compete in an increasingly regulated environment. Simply maintaining traditional operations will no longer be sufficient in this new reality.
Try flipping through an industry trade magazine without being inundated with serialization messages. It’s almost impossible. The reason is that manufacturers en masse are moving to upgrade their thousands of packaging lines around the world within a compressed period. Even though there are a myriad of serialization solutions available, only a few offer the flexibility and scalability needed to work on a global level. Yet, there is no doubt that the demand for high-quality serialization manufacturers, data management vendors, and system integrators will soon outstrip the supply.
In 2010, the U.S. Food and Drug Administration (FDA) issued its final guidance to the industry regarding serialization mandates. Since then, the pharmaceutical industry has rallied around the use of 2D data matrix codes to provide unit-level product visibility during manufacturing and throughout the supply chain. Coding at the unit level and communicating those codes to an MES or other data management system is a technically challenging endeavor. To ensure the serialization process is reliable, manufacturers will require a cross-functional team focused on product handling, controls integration, line equipment, and data management software. The greatest industry demand will be for solution providers that offer expertise in these areas and have established working relationships with strategic partners.
Finally, delaying serialization will cost manufacturers ROI benefits. The need to serialize is not just meeting a regulatory requirement; serialization is also about product visibility. Buried within the confusion and excitement of serialization are many opportunities to gain competitive advantages. For instance, tracking product at the unit level will increase quality assurances and open channels to the end user like never before.
The fact is there is no time left to wait. Either serialize now or risk losing market share within a few years.
Myth 2: I Need an Expensive Automatic Case Packer to Effectively Serialize
As the serialization market matures, common misconceptions are beginning to fade. A prominent, lingering serialization myth is that high-end automatic case packers are a necessity. Let it be stated with certainty that an automatic case packer is not a requirement for an effective serialization strategy. There are secure solutions available for manual and semi-automatic operations. In fact, the majority of manufacturers will likely adopt low-cost manual case packing solutions instead of higher-priced alternatives.
Serialization, in its simplest form, is about coding and verifying codes. If a product has a bad code, then reject the product. If a code doesn’t belong in a case, then replace the bad product or don’t let the case proceed. The print, label, vision, and reject capabilities to achieve serialization exists and has been in use on packaging lines for quite some time. The challenge is to frame these capabilities together and to integrate them with data management software. Manufacturers can reduce this burden by being prepared with a detailed user requirement, including desired line speeds, code placement, container orientation, and case dimensions. With this, vendors can determine the appropriate degree of automation that will enable desired line speeds and overall efficiency.
Controls and software should take care of the serialization activities without disrupting operator work flow. Visual feedback systems and fail-safe conditions discreetly confine an operator to an “electronic path” until the operator satisfies the serialization requirements.
By taking this approach, the manual case packing station becomes a semi-automated process with the operator handing off some operations to automated systems. Ultimately, the collaboration between the serialization vendors and end-users will dictate the balance of automation needed to achieve desired line speeds while keeping down costs.
Myth 3: I Can Rely on an Upstream Sequencing Method
From a packaging perspective, there is a monumental risk with assuming that bottles will stay in the same sequence as they travel down a packaging line. All it takes is one misplaced bottle to disrupt the entire parent-child hierarchy in the database, which could undo days or weeks of production
This is exactly what happened to a top-five pharmaceutical manufacturer within two months of deploying their serialization solution based on upstream sequencing (FIFO or First In, First Out). Now this manufacturer is reconfiguring its serialization solution to a more secure method that doesn’t rely on bottle sequence. In hindsight, they learned, it wasn’t a matter of if the sequence would screw up, but when.
The philosophy behind secure aggregation is to create physical aggregation prior to data aggregation. In other words, put the products into a bundle or case and then read the codes. This approach provides absolute certainty that the physical contents match the information in the serialized database.
A robust track and trace system can provide information on individual units throughout the supply chain. Serialization partners should work together to bring the benefits of unit-level tracking into their packaging lines.
The call to action here can be summed up in just four words: Time is running out.
California and global regulations will ultimately force manufacturers to comply or force them out of market share. The sooner that manufacturers acknowledge this, the better positioned they will be to secure the high quality vendors needed to assist them with their serialization strategy. Manufacturers with manual case packing operations can implement a secure serialization strategy without purchasing automatic case packers. Manufacturers are strongly encouraged to choose an approach that employs secure aggregation as opposed to upstream sequencing.
About the author
Chris Siegele is a Serialization Specialist for Omega Design Corporation. Omega Design is a global provider of innovative packaging solutions, specializing in the design, manufacture, service, and support of a broad range of container handling and packaging equipment systems. Omega’s brand protection division, Unit Level, deploys and services serialization solutions along packaging lines. Solutions are on display in the Serialization Demo Lab at its headquarters outside Philadelphia, PA.