In complying with the U.S. Drug Supply Chain Security Act regulations, pharmaceutical manufacturers must ensure their ERP systems are up for the task.
In late 2013 the Drug Supply Chain Security Act (DSCSA) was introduced and signed into law as a means to govern the management of pharmaceutical drugs manufactured and sold in the United States. It specifically aims to build an interoperable system that oversees the way these prescription drug products are identified and the traceability that is required of them. The law sets the groundwork for a systematic approach to providing information, down to the individual package level, about where that drug product has been throughout the supply chain – all in an effort to combat the global market for counterfeit medicines.
The three main goals the DSCSA strives to achieve include:
- Verifying the legitimacy of the drug identifier down to the individual package level
- Improving the detection of fraudulent products in the supply chain
- Facilitating more efficient recalls of drugs when necessary.
Over the course of its 10-year enactment period, the DSCSA has three main implementation phases that affect pharmaceutical organizations and the ERP software they use to run their businesses. This phased approach began in 2015 with lot-level management.
Drug makers are required to have the ability to share transaction information, history, and statements at the lot or batch level of identification. Each time the drug is sold in the U.S. market, manufacturers, contract packagers, and wholesale distributors are required to provide the purchaser with this product tracing information.
These transaction reports should include three main pieces of information:
- Transaction Information (TI) like lot numbers of the product, dates of the transaction, and dates of the shipment;
- Transaction History (TH) that includes information for each prior transaction back to the original manufacturer;
- And the Transaction Statement (TS) that declares certain information that the entity is authorized under the DSCSA, did not knowingly ship illegitimate product and had systems in place to comply with verification requirements.
Pharmaceutical manufacturers are finding that the most efficient means of reporting on this information comes from the same ERP software that is used at the formulation, QC, and production levels. This type of single-system is able to report on production history quickly and efficiently, and provide the granular detail that the transaction documents require. This approach to accessing data and generating reports directly from the single source ERP system is proven to be very effective when dealing with product recalls as well.
The second phase of the DSCSA bill begins in 2017. Here the focus is on item serialization. To meet this phase of the requirements, manufacturers must serialize packages of their drugs using a product identifier, serial number, lot number, and expiration date. As drugs are moved through the production process, the software used to finish a job must be able to automatically assign serial numbers, generate, and print their corresponding labels at the individual package, case, and palette levels. Of concern to most pharmaceutical manufacturers about this particular requirement is the potential to slow down their current speed of production. Only an automated system that can handle speeds upwards of 100 or more units per minute, and that is an inherent part of the overall ERP used to run the business, will provide the biggest performance benefits while at the same time meeting the requirements.
Just as critical is the access to serialization-relevant data that must be distributed widely across the business. When separate systems are used on the plant floor and have to be bridged together with those used at the enterprise-level, bottlenecks have a tendency to occur. Legacy ERP systems, or those that have been so highly customized that they can’t be upgraded, are all hindrances to meeting these requirements. Pharmaceutical manufacturers are better suited to a single, cohesive ERP system that can provide immediate, real-time access to their serialization data.
The third, self-executing phase of the DSCSA, to be implemented by 2023, is based around complete, serialized item-level traceability. The law requires that companies make available the information that would allow members of the entire supply chain to trace the ownership of drug products back to the initial manufacturer at the package level, not just the lot. Organizations must have a system in place that supports the requirements of a secure, interoperable, and electronic exchange of Transaction Information and Transaction History. The manufacturing software used to provide the traceability of lot-level serialization today, should already at the same time be able to provide the tracking of item-level serialization as well.
As the mandates of the Drug Supply Chain Security Act continue to become realized, pharmaceutical manufacturers are finding themselves in front of a growing list of requirements that will ultimately ensure the legitimacy of products within the U.S. drug supply chain. Having a modern, all-inclusive ERP system in place that is capable of meeting the traceability, serialization, and reporting requirements of the DSCA will define the level of success that manufacturers have in complying with these regulations.