The proliferation of generic drugs-- which make up 80% of the global healthcare market-- has opened the door to counterfeiting, the illicit manufacturing and distribution of fake medicine.
In an effort to counteract the counterfeit industry, the OPC Foundation has formed a working group addressing compliance to healthcare counterfeiting regulations. The Open Serialization Communication Standard Working Group (Open-SCS) is developing an industrial interoperability standard and the associated requirements templates, which are expected to be released by the end of 2015.
The Open-SCS is focused on standardizing packaging line serialization and interoperability across the plant’s equipment and systems, as well as between supply chain systems. The work being done is focusing on four main functional aspects including serialization, aggregation, data management, and IT implementation.
Serialization legislation from many countries dealing with the global healthcare counterfeiting crisis requires serialization and aggregation of products from the manufacturer to the patient. This means that production floor and warehouse equipment and systems must be able to exchange information with the manufacturers’ supply chains and the patients’ support systems. The Open-SCS scope serves as the blueprint on how these data exchanges define and simplify the base roles for each actor in the data flow; define communication protocols used for each connection point; enable greater flexibility of the serialization architecture; and reduce integration cost and delays.
Open-SCS outlined six proposed use cases critical to complying with healthcare product serialization regulations:
- Serial number provisioning used to issue and track valid and unique serial number ranges or lists.
- An Electronic Product Code (EPC) repository for the disposition and aggregation status of all EPCs produced by a packaging line at each plant, warehouse, and distribution center.
- Batch & master data repository for the line level and master data required to configure packaging line equipment.
- Unused serial number return used to track and return unused serial numbers to the serial number manager.
- Full batch import for plant and line data collection with a high volume enterprise interface to obtain the disposition and aggregation status of all EPCs linked to a batch identifier.
- Serial number inquiry for plant and line data collection with a high volume enterprise interface to obtain the disposition and aggregation status of a specific EPC.
The Open-SCS standard and specifications are heavily influenced by—and maps directly into—the rapidly evolving supply chain serialization regulations, their associated standards, and systems approaches. To facilitate this, Open-SCS will have active representation in supply chain groups such as GS1, Rx-360, ISA and ISPE.
The products are intentionally scoped as a “plug-and-deploy” set of user and functional requirements for data exchanges between the equipment level, operations management level and the serialization supply chain platforms. This scope directly addresses regulations requirements currently not covered by supply chain standards organizations.
“Current interoperability standards such as OPC-UA, ISA-95/88/B2MML, EPC-IS, PackML, and others do cover most of the requirements but in no standard implementation form across the available parts,” says Charlie Gifford, executive director of the Open-SCS Group. “A single standard interoperability implementation will sufficiently cover the entire requirement for healthcare serialization compliance.”
The OPC-SCS Steering Committee members include Abbott, Teva Pharmaceutical Industries Ltd., Famar Health Care Services, Mylan Pharmaceutical, NNEPharmaplan, SAP AG, OptelVision Inc., Systech International, Werum IT Solutions GmbH, and Antares Vision Srl.