Data Analysis Enables Consistent Quality in Pharmaceuticals

How looking at data the right way improves the quality of pharmaceutical supply chain orchestration

The Internet of Things, social media, structured customer feedback and human perception generate a wealth of information that is of central importance for analysis in the pharmaceutical industry. This data identifies early indicators of performance problems, prevents a recurrence of CAPA (Corrective and Preventive Action), and helps diagnose customer complaints faster.

Imagine that a single drug, which is administered in hundreds of hospitals and doctors’ offices, is distributed throughout the US, which has over 5000 healthcare facilities. With such a broad distribution, it can be hard to track and manage quality, orders, inventory, and shipments. The Elemica PLATFORM connects all trading partners – suppliers, health care providers, hospitals, pharmacies, manufacturers, and logistics service providers – giving visibility into quality management and other supply chain issues. The Elemica PLATFORM collects data from the IoT sensors in real-time or at set intervals and integrates the data with Elemica QUALITY to monitor and report on product transit and usage.

In the case of temperature-dependent goods within the pharmaceutical industry, monitoring of temperature fluctuations and handling is necessary and has major impacts. Transporting biologics, for example, is no easy task. Each shipment of these specialized medications, which are produced using living organisms, requires a strict temperature range of two to eight degrees Celsius and can be worth up to $50 million. According to the current state of the art, this data can be collected for example, by sensors or smart pallets.

Improper container movements at the port or in the warehouse can also be the cause of quality losses. The aim is therefore to use the analysis to identify trouble areas and support logistics providers and suppliers in optimizing their processes. Elemica SEE improves visibility into supply chains by providing tracking with real-time notifications, helping to uncover bottlenecks within the supply chain.

Other aspects that should be taken into account are fluctuations in the material composition. Statistical Process Control, Pareto analysis, and the analysis of problem origins are good methods for tracking of material fluctuations. Typically, this is a cumbersome and labor-intensive activity. Non-Conformance and corrective actions can be implemented for the logistics process. The ideal solution for suppliers and logistics service providers is to provide all material properties digitally, so that material variations can be found immediately and shared between customers and suppliers worldwide.

Elemica QUALITY helps pharmaceutical manufacturers to improve their supplier quality programs with anti-counterfeit measures and a sharper focus on the supplier pedigree. The cost of poor quality resulting in rework, waste, delays in product approval, resource inefficiencies, corrections and removals, enforcement actions, which impacts the bottom line can be all managed and improved with Elemica QUALITY. It places the proper emphasis on the control of suppliers with better collaboration, resulting in standardized practices and processes, and improved transparency and auditability.

If you need help managing quality in your supply chain, contact Elemica today.