Many pharmaceutical manufacturers are concerned about label design and placement to accommodate a serialized label. These are, of course, very legitimate concerns. However, there are much more complex issues at hand, including the importance of standardization, scaling information technology infrastructure, agility to accommodate regulatory changes, and data security.
Why Serialization Matters
The first objective of any pharmaceutical company is to deliver safe and effective medicines to patients. While historically there have been methods to provide product visibility and control along the supply chain, the processes have been highly manual, with paper-based record keeping being the prevalent modality.
Due to counterfeiting, adulteration, theft, and diversion, governments and regulatory agencies have developed regulations to enhance patient safety and supply chain security. In November 2013, H.R. 3204 was presented by the Drug Quality and Security Act (DQSA) and the 113th Congress passed into Public Law No: 113-54 (11/27/2013) Title II: Drug Supply Chain Security Act – (Sec. 202). This law establishes requirements to facilitate the tracing of prescription drug products through the pharmaceutical supply distribution chain (H.R.3204 - Drug Quality and Security Act, 2018).
Serialization refers to the new requirements for application of a unique identification code, a serial number or electronic product code (EPC). The serial number should be applied to each unit in GS1 standard 2D DataMatrix and human-readable formats. The units can be tracked through its entire supply chain, from production to retail distribution to final dispensation to the patient. The DQSA mandates that all prescription drugs sold in the United States must be serialized at both the saleable unit level and the case level by November 2018.
“In the pharmaceutical industry, counterfeit and falsified drugs pose a global public health risk. These drugs may be not only ineffective but actively dangerous, causing adverse reactions or even death” (Serialization: What It Means For Pharmaceutical Manufacturing, 2018). Additionally, counterfeit drugs may be mass-produced in multiple locations making them problematic to track and remove from the supply chain. When fully implemented, serialization will lead to increased transparency and visibility by reducing counterfeiting, diversion, and theft.
Top Four Challenges
- High Volume and Complex Data Exchange Calls for Standardization
When large amounts of data need to be shared rapidly, among many trading partners, standardization of that data is the only logical path forward. Members of the pharmaceutical industry collaborated in GS1 working groups to establish standards. Ultimately, the industry coalesced around the use of Electronic Product Code Information Services (EPCIS) for lot-level management and item-level traceability. EPCIS is a GS1 standard that enables supply chain partners to capture information about supply chain events (e.g., shipped, received, etc.) and securely share that information with their trading partners in near real time.Full execution of Title II of the DQSA dictates that data will be exchanged across a very complex and diverse set of supply chain partners: in-house packaging facilities, packaging facilities of contract development and manufacturing organizations (CDMOs), third-party logistics providers (3PLs), repackagers, wholesalers, and dispensers.
- Ability to Scale Information Infrastructure
The transition from lot-level tracking to unit-level serialization and traceability will create vast amounts of additional data. Within a serialized world, data and other transactional information related to each uniquely serialized product are captured and transmitted as the product is packaged, shipped, and verified. It is easy to see that the data that must be generated, captured, and managed within a product-level serialization construct are orders of magnitude larger than the data gathered and generated for lot-level tracking and distribution.
Additionally, this data must be generated and managed at operational speeds– the enterprise information infrastructures and relational databases within many pharmaceutical organizations simply are not designed to manage this volume of data, particularly at the high speeds required. Pharmaceutical organizations must strategically plan for the ability and need to scale their information infrastructures as the volumes of data that must be managed to grow exponentially within a very short period.
- Agility to Accommodate Regulatory Changes
Regulatory changes are common within the United States and around the world. As product-level serialization is implemented, both regulatory bodies and relevant industries will gain experience and acquire learnings that could lead to adjustments in the regulations. For instance, the aggregation of serialized data is not a requirement of United States law today. However, it will likely be a requirement at some point in the future. Pharmaceutical companies will be well served to build a serialization infrastructure that can be altered as needed to accommodate regulatory changes.
- Data Security
With vast sums of data being transmitted to many trading partners within the pharmaceutical supply chain, careful consideration needs to be given to data security. Data must have high integrity and be free of corruption for effective use by members of the pharmaceutical supply chain, and data must be protected from hackers and other cyber criminals. Serialization is, of course, meant to protect and validate the identity of a product throughout the supply chain. Therefore, it does not take much of a leap of imagination to envision how cyber criminals could benefit by manipulating the identity of high-value products.
Serialization execution goes far beyond printing numbers on a package– that is the easy part. The true challenge lies in the ability to couple physical product flow with electronic data flow. A very robust information technology (IT) infrastructure is required to generate, store, capture, and transmit unique serialized data across many products. Adding to the complexity, data must be nested– product, case, pallet, and lot.
The end result is that, by 2023, the deadline for full track-and-trace implementation, an enormous amount of data will need to be generated at operational speeds, correctly assigned to a given product, stored, and transmitted to all appropriate supply chain partners. That data will then need to flow seamlessly between clients and their CDMO or Contract Packaging Organization (CPO). Therefore, serialization system ecosystems will need to be carefully designed, and the correct IT and project managers will be required to facilitate this exchange.
Thank you for your interest in learning more about the serialization process. At Alcami, we are committed to consistent regulatory compliance. Connect with one of our experts to achieve the best outcome for your product at every level.