The FDA recently issued Final Guidance for Industry Standards for Securing the Drug Supply Chain. The publication recommends unique identifiers in the form of a serialized National Drug Code (sNDC) on prescription drug packages. It also aligns the FDA sNDC with the same GS1 product serial number definitions embraced by similar agencies in Brazil and Europe, and points toward an emerging global consensus on how 100% traceability and product authentication can be achieved.
One constant theme is emerging: The need for product authentication delivered using codification and mass serialization.
Manufacturers working towards compliance with new serialization requirements or seeking improved product traceability for brand protection or supply chain optimization will have to retrofit existing production equipment with the proper printers, vision systems and ID readers.
In order to avoid derailing production when implementing a serialization strategy amid evolving regulatory and compliance environments, we offer these ten essential steps that must be considered.
1. Internal assessment: Conduct a thorough internal assessment. Determine why you need traceability. Do you want to achieve greater inventory visibility? Improve the returns process? Detect and eliminate counterfeiting? Detect and reduce “gray” market activity? Have access to more timely and accurate sales data? Speed up and reduce the cost of the recall process? Achieve more accurate order fulfillment and shipping? Enhance reputation with customers and the public? Comply with regulatory requirements? There are a wide range of uses for traceability information, and the first step is figuring out what you want accomplish with it. Is the scope of the traceability objective limited to product integrity on the production line to track production parameters and ensure product quality for risk management? Is it part of a broader initiative that includes brand authenticity and return validity assessment? Will serialization be the foundation for optimizing business practices where the traceability information will be used for automated routing and inventory control? Or, do you want to maintain channel integrity, protect against counterfeiting, detect diversion and fraud, or comply with regulations?
2. Project ownership and budget: Determine who owns the traceability project and budget. Don’t ignore that serialization can involve change that may require new methodologies and processes that will need to be defined and validated. Most traceability projects require input from multiple teams such as manufacturing, engineering, validation, operations, information technology and marketing. It may cover, for example, packaging and design, data management, warehouse execution systems, line configuration and other areas.
3. Stakeholder buy-in: Get input from all the various stakeholders to develop a strategic approach that covers not only how traceability will be implemented, but also to organize where various parts of the program and development responsibilities fall.
4. Data requirements: First, figure out who is going to consume the traceability data once it has been generated. Is it marketing? The quality department? Production tracking? Inventory control? Engineering? Once you know who will be consuming the data, determining the data requirements is more straightforward. This is a critical step because everything in a traceability project, such as code design, label design, IT infrastructure design, and all the rest, tends to be configured around the data requirements.
5. Code Design: Today, all manufacturers uniquely code each lot or batch to identify time and location of production and make recalls more efficient and less costly. But this is not sufficient for full traceability where the code must be unique for each product, especially if the time stamp goes to the minute and the production rate is 200ppm. Serialization is a lot more complex than just generating numbers and printing them on a label. To avoid derailing production, the information will have to be encoded into a barcode, Data Matrix, or some other machine readable data carrier in order to automate data capture during production. Another factor to consider when implementing code design for a traceability system is that serialized packaging or product marking has to fulfill a defined life cycle from generation to allocation on the product and beyond. That means to create the unique serial number requires permission to generate it and permission to distribute it.
6. Label design: At some point the code will have to be added to a label or in some cases etched onto the product itself. Along with location and size of the code, the longevity and readability of the code also needs to be taken into consideration. For instance, if traceability is going to be used to audit production samples after they’ve been shipped to the end user, then one must make sure the code is located in a location free from abrasion during shipping and that the code printing material is resistant to the environment to which it will be exposed.
7. Technology Audit: Serialization will require many facilities to re-tool printers, vision inspection systems, as well as ID scanners and readers. This will either require a recipe\software change of existing equipment that meets the new requirements, or the installation of new equipment. Assess the production line’s capability to produce and read the traceability marker. If Data Matrix is used, then make sure printers and readers on the line are capable of marking and reading it at the highest production rates. In some cases, the right technology might be in the wrong place. For example, you may want to begin tracking your product as raw material entering the plant but there is only an end of line label printer before packaging that can apply the correct traceable mark. If the correct technology is not in place there will be some capital expenditures needed to get the traceability initiative off the ground. It’s good practice to, wherever possible, leverage existing investment in technologies and processes such as site level vision systems and printers. However, ultimately, it’s best to go with the software, printers, vision systems and ID readers that meet performance requirements and are easy to install, while requiring the least amount of resources to maintain. For example, when retrofitting existing equipment and production lines, new smart camera vision systems can be less expensive to install, less complex to validate, and less costly to maintain than traditional PC-based inspection systems. Also, a distributed model using smart cameras minimizes the effect of equipment failures as the failure of one camera will not bring down the entire system.