Pharmaceutical producers around the world are either planning or in the process of implementing serialization platforms to comply with anti-counterfeiting regulations.
And while the regulations require that serialization be used to help protect pharmaceutical supply chains, they don't detail how serialization platforms should be implemented.
This has led to the development of a variety of different serialization approaches and platforms – leaving pharmaceutical producers with the hefty responsibility of deciding which approach they will commit to for years to come.
Those tasked with selecting and implementing a serialization platform in pharmaceutical operations should consider the benefits of an open and holistic platform. Such a platform can help reduce upfront implementation and long-term support challenges, while also allowing them to get the most out of serialization in their operations.
A number of factors help set an open and holistic serialization platform apart from others, and manufacturers should ensure their solution checks the box in some key areas.
For example, the platform should use an open architecture to interface with the producer's existing equipment and support a variety of software, including different operating systems and databases. This can minimize production interruptions and validation burdens compared to a proprietary or “black box” serialization platform, which can present interoperability challenges with batch and processing systems, and at the plant-floor level.
The absence of proprietary technology also can provide a bonus in that it gives pharmaceutical manufacturers greater freedom in choosing a support provider for the serialization technology. Instead of being restricted to the platform's developer, the manufacturer can select the OEM, system integrator or solution vendor of its choice to provide system repairs and troubleshooting support.
Another important characteristic is the use of open network and communication protocols to support full interoperability across all levels of the ISA-95 data model – from the controllers, cartoners and printers on the plant floor up to the ERP and supply-chain levels.
And an Electronic Product Code Information Services (EPCIS)-certified event repository database will provide serial-number generation and supports data sharing across disparate applications. This can help companies meet global serialization regulatory requirements but also deliver new levels of visibility into activities occurring throughout the supply chain.
Upon implementation, an open and holistic serialization platform can provide interoperability benefits across all levels of the ISA-95 model.
For example, it can expand Level 0 to include not only packaging devices, such as the printing, vision and RFID systems, but also the packaging machine itself. This keeps all packaging equipment on the same level and allows increasingly sophisticated serialization data to be created and managed above Level 0.
Beyond the plant floor, a holistic platform also can provide visibility across a pharmaceutical manufacturer's enterprise and supply chain – perhaps even out to the customer level.
For example, if a product-quality issue was to arise, the manufacturer could trace a product's data thread backward through the distribution chain to the source of the problem. Using this information, the manufacturer can identify the other packages in the same pallet as the affected product, identify where they were shipped and have them removed from store shelves – or directly contact customers who purchased them.
Greater visibility also can help manufacturers in a number of other ways, including authenticating returns, optimizing supply-chain planning, improving chargeback payment accuracy, and much more. The potential is primarily limited to the manufacturer's imagination.
For more information about serialization considerations and the benefits of using an open and holistic platform, read our recently published white paper: “Serialization: An Implementation Guide.”