Analyst Insight: To address changing patient and market needs, pharmaceutical companies are expanding their product portfolios to include specialized and even individualized drugs. Precise, real-time control is indispensable to avoiding quality issues during the production or shipment of these smaller-batch items. To support this growing trend, systems of the extended supply chain need to be integrated to provide synchronization and process visibility.

As more and more of the supply chain falls outside of the direct administration of the pharmaceutical manufacturer, digitization of supply-chain processes is key to maintaining control and visibility. More importantly, digitization is required to help meet government regulations on the tracking and tracing of materials, from raw-material suppliers to end customers. A multi-channel network that extends control and visibility beyond the four walls of the business to all partners, including material suppliers, manufacturers, packagers, and transporters, allows everyone on the network to see relevant information, so they can better manage their component of the supply chain.

The Drug Supply Chain Security Act mandates that manufacturers and distributors of pharmaceuticals in the U.S. must fully comply with new traceability regulations by 2023. In the event of a recall of a drug or its component, companies will need the ability to identify every place in the supply chain where the problem product exists, whether in storage, a manufacturing facility, on a truck or in a distribution center. The key to this granular level of traceability is visibility across an extended supply chain, which gathers information from all connected shareholders.

In order to track and trace from raw-material suppliers through to the end patient, drug manufacturers need data structures that support batch numbers, lot numbers, serial numbers, packaging levels and quality information, across both raw materials and finished goods. Ideally, a finished-good certificate of analysis (COA) will reflect the quality characteristics of the product and its components. This should include all details (such as manufacturing, movements, operations and quality) of raw materials and finished goods as they move through the supply chain and are ultimately consumed.

Today’s pharmaceutical companies often rely upon contract manufacturers to maximize flexible, high-quality production at the lowest possible cost. With the trend toward production of more specialized, smaller batches of medicines, the systems of the extended supply chain need to be integrated to provide synchronization and process visibility. Data flowing from these systems needs to be orchestrated, including raw material and packaging orders; contract manufacturing orders; raw, intermediate and finished goods movements; transportation orders and status; shipment status, and receipt of goods.

Outlook:

In the future, pharmaceutical manufacturing will be more automated and flexible, with better intelligence about the quality of goods. Manufacturers will be able to provide surgical insight into each pill in a blister pack, and understand every detail in its lineage. Track-and-trace and quality-management solutions will become embedded in the everyday workings of pharmaceutical manufacturers, making it easier to solve counterfeit drug challenges, and to save lives.

Gary Neights is Senior Director of Product Management with Elemica.