What Is Pharma Serialization?
by Regina Fullin, Compliance Consultant at Compliance Team, Inc.
Counterfeit medication is a worldwide problem. Many of us in the United States may be surprised to realize that, in some countries, up to 70% of pharmaceutical products are counterfeit, and that 30-50% of medications used worldwide for treating serious diseases are counterfeit. It’s no wonder that countries (U.S., Brazil, France, Turkey among others) are implementing serialization requirements to discourage counterfeiters by making counterfeit products more detectable. Equally true, pharmaceutical companies want to capture the sales lost to counterfeiters.
Serialization creates a new, logistical problem to replace the initial problem of illegitimate / counterfeit products. On its face, serialization is simple. The manufacturer places a unique, identifying code on each unit of pharmaceutical product, and identify units at higher packaging levels (packs, cases, etc.) so that units can be traced throughout the supply chain. At the pharmacy or end recipient, the identifying code can be traced back through every transaction until it reaches product release from the pharmaceutical company, in order to authenticate the product.
A pharmaceutical serialization system can be complex, but there are ways to simplify the process and make the system add value to your organization. Begin with true understanding of pharmaceutical packaging operations, by leveraging the power of Value Stream Mapping (VSM). Value Stream Mapping is a variation on the Process Flow Diagram that explores which steps add value to a process and which steps are wasteful. Since serialization has the potential to overhaul many processes, it becomes necessary to use VSM to capitalize on the opportunity to eliminate wasteful work, and prevent building systems that add new layers of waste on an already-wasteful process.
Simply implementing an automated solution without first thinking through your process will only add unnecessary complexity to your process. I cannot emphasize this enough.
The next stage is to have a clear vision of your serialization end-game for an integrated solution. This requires the input of many functional roles within a cross-functional team. For example, the Regulatory Affairs group will provide input on labeling and the serialization laws in each of the countries where the product is marketed. Engineering will provide input on the coding solution, and Operations will provide input on the manufacturing floor layout and workflows that will best support the serialization process and personnel. Quality may get involved for selection of suppliers, and Logistics will become involved on supply chain aspects.
For an integrated solution, the cross-functional team will also need to develop User Requirements for the integrated solution, which will be compared against the Value Stream Map to create a gap assessment. From this state, the team can develop Functional Specifications to address each of the User Requirements that require further development. The added value using this approach is that it lays the groundwork for validation planning and the necessary validation protocols to ensure that the solution corresponds to your team’s original vision.
When building the solution, be sure to consult with experts in the field, while accounting for your own needs. Speaking to a non-partisan representative, such as GS1 (an international barcode standardizing body, will help clarify your company’s vision. Working with your controls systems engineers, who understand how to integrate serialization in the company’s current systems will also be useful. Speak to your technology vendors.
Be open to learning something from technology vendors, but remain true to your specifications. Technology associated with a serialization project could speed up a production line, allowing for line consolidation and cost reduction, but be aware that technology vendors may be blind to your company’s specific needs, and may suggest solutions that don’t make sense for your situation. This is why it is important to be clear about your company’s vision before seeking outside help.
In fact, for smaller companies, technology solutions may be inappropriate. There is no specific need for automated case-packers, for instance. A sound manual process may save time and money, and be easily validated. For instance, a semi-automated process for manual packing and scanning boxes within a case may prove more effective than some technology solutions. In all cases, large and small companies should avoid errors by scanning boxes after packing them in a case, since automated systems cannot predict 100% of the box/case association.
In addition to packaging operations, a serialization effort is a good time to re-evaluate business relationships, and simplify in those areas too. If multiple trading partners service a particular geographical area of your supply chain, it may be time to consolidate to the trading partner that best embraces the role of supply chain security. It may prove useful to get value by making larger-volume agreements for reduced pricing, or to find supply chain partners who specialize in the needs of pharmaceutical clients.
A well-conceived serialization strategy will result in supply chain realization that more than covers the costs of the effort, but can also create value in the long-term. For example, serialization can help reveal inefficient operations in-house. Outside the company, serialization can locate the final geographic areas of product sale. Such final barcode scanning can become a way of tracking areas of higher-demand for your product. This knowledge can impact long-term decisions, such as where to build your next pharmaceutical plant. Further business uses include verifying reimbursement claims. The serialization ID can be a means of collecting customer data about a product, to improve marketing efforts, by tracking customer purchasing patterns, identifying geographic areas of lost sales or brand-switching. Think of the profitable opportunities above and beyond capturing sales lost to counterfeiters selling knock-off versions of your product!
Serialization is an expensive effort, but with proper planning, it can be leveraged to make your organization simpler and more efficient, yielding return-on-investment. By carefully planning out which process steps to eliminate, and which steps to automate, your serialization process will banish waste. By re-thinking the way your organization does business, serialization can be a means of improving service delivery by streamlining your supply chain, and finding new ways to improve customer relationships.
Sources:
Frederick, Jim. “Counterfeit Threat Intensifies” Drug Store News, August 24, 2011, accessed from
Markarian, Jennifer. “Considering Full Serialization” Pharmaceutical Technology Equipment Processing Report Issue 8, June 17, 2015
Mettler-Toledo Hi-Speed. White Paper: A Guide to Pharmaceutical Serialization, accessed from http://www.southeasternpackagingeqipmentsales.com/pdfs/resources/Serialization.pdf
Packexpo. Serialization Delivers Benefits Beyond Pedigree Data, September 13, 2011
Shanley, Agnes. “Serialization: Are You Prepared? Why This Time is Different.” Pharmaceutical Technology Outsourcing Resources Supplement 39 (17) August 1, 2015
Siegele, Chris. “Pharmaceutical Serialization and Implementation Myths” April 11, 201