The Advantages of EPCIS for Pharmaceutical Serialization

The pharmaceutical industry has long been in need of a reliable and efficient way to track and trace products through the supply chain. With the increasing prevalence of counterfeit and substandard drugs, as well as requirements from regulations such as the Drug Supply Chain Security Act (DSCSA) in the United States, pharmaceutical serialization has become a top priority for many companies.

One technology that has emerged as a frontrunner in this space is Electronic Product Code Information Services (EPCIS). EPCIS is a standardized format for exchanging supply chain event data, developed by GS1, the global standards organization for the supply chain. In this blog post, we will explore the advantages of using EPCIS for pharmaceutical serialization.

Improved Data Integrity and Accuracy

Pharmaceutical companies are required to maintain a high level of data integrity and accuracy throughout the serialization process. This is especially important when it comes to sharing data with other companies in the supply chain, such as wholesalers and retailers.

EPCIS offers several advantages in this regard. First, the standardized format ensures that all parties are using the same data structure, reducing the risk of errors caused by incompatible data structures. Additionally, EPCIS provides a clear audit trail of all events related to a product, from production to dispensation. This means that companies can easily track down any errors or discrepancies in the data and take corrective action.

Overall, using EPCIS can help ensure that the data used for pharmaceutical serialization is accurate, reliable, and consistent across the entire supply chain.

Increased Efficiency and Productivity

Pharmaceutical serialization can be a time-consuming and resource-intensive process, requiring significant investments in both hardware and software. EPCIS can help streamline this process by reducing the need for complex integrations between different systems.

Because EPCIS provides a standardized format for exchanging data, it can be easily integrated with other software and hardware systems used in the supply chain. This means that companies can avoid the need to build custom interfaces and costly integrations between different systems, reducing both the time and cost of implementing pharmaceutical serialization.

Additionally, EPCIS can help increase productivity by providing real-time visibility into the location and status of products in the supply chain. This means that companies can take proactive measures to prevent issues such as stockouts and expiration of products before they happen.

Improved Regulatory Compliance

Pharmaceutical serialization is mandated by a number of regulatory agencies around the world, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These regulations require companies to implement a reliable and efficient way to track and trace products through the supply chain.

Using EPCIS can help companies meet these regulatory requirements more easily and efficiently. Because EPCIS provides a standardized format for exchanging supply chain event data, companies can easily demonstrate compliance with regulatory requirements by providing auditable records of product movement and disposition.

Additionally, EPCIS can help companies remain compliant with changing regulations, such as the upcoming requirements of the DSCSA in the United States. By providing a flexible and adaptable data structure, EPCIS can help companies quickly adjust to changing regulatory requirements without significant disruption to their existing systems.

Enhanced Supply Chain Visibility

One of the most significant advantages of using EPCIS for pharmaceutical serialization is the visibility it provides into the supply chain. With EPCIS, companies can track and trace products at every stage of the supply chain, from production to dispensation.

This increased visibility can help companies identify and address issues such as counterfeit products, stockouts, and expiration of products. Additionally, it can help improve supply chain efficiency by providing real-time data on product availability and location.

Finally, enhanced supply chain visibility can help companies improve customer satisfaction by providing accurate and up-to-date information on product availability and delivery times. This can lead to increased customer loyalty and repeat business, benefiting the company in the long-term.

Conclusion

Overall, EPCIS provides significant advantages for pharmaceutical serialization, including improved data integrity and accuracy, increased efficiency and productivity, improved regulatory compliance, and enhanced supply chain visibility. By adopting EPCIS, pharmaceutical companies can improve their competitive position, build customer loyalty, and meet regulatory requirements in an efficient and cost-effective manner.

As a standardized format for exchanging supply chain event data, EPCIS represents a major step forward in the industry's efforts to combat counterfeit and substandard pharmaceutical products. It is an essential tool for any company looking to implement pharmaceutical serialization and maintain compliance with evolving regulatory requirements.