How a Pharmaceutical Giant Ensures the Safety and Authenticity of Medicines Through Serialisation

In an era where pharmaceutical traceability is paramount, Aspen Australia, a subsidiary of Aspen Pharmacare Holdings Limited, has emerged as a trailblazer in implementing robust global standards to combat the threat of falsified medicines. The company’s proactive approach to adhering to regulatory requirements and adopting GS1 standards has not only safeguarded its market presence but has also set a benchmark for the industry.

The Challenge

The pharmaceutical landscape is constantly evolving, with stringent regulations aimed at preventing the circulation of counterfeit drugs. As a Contract Manufacturing Organisation (CMO), Aspen Australia faced a significant challenge when awarded a contract manufacturing portfolio for new Middle Eastern markets. These markets demanded compliance with serialisation requirements, emphasising the GS1 DataMatrix barcode.

The Solution

Aspen embarked on a meticulous journey to implement a serialisation system, choosing a Point of Dispense Authentication (PoDA) model. This model focuses on serialisation at the sales unit level, ensuring traceability at the point of dispensing. The selection criteria for the implementation encompassed flexibility, scalability, ease of use, ubiquity, innovation, technical implementation, customer service, and cost considerations.

How the System Works

The Serialisation system’s workflow involves the automatic replenishment of product-specific serial number pools, the creation of serialised orders that reserve the required quantity of serial numbers and then download when assigned to a packing line. The GS1 DataMatrix barcode encoding the unique product identifier, expiry, batch/lot and serial number is printed, verified, and linked to production data at the line level. The serial numbers are then transferred by the Market Authorisation Holder (MAH) to the regulatory body’s database, ensuring authenticity can be verified at the point of sale.

The Challenges

The implementation journey was not without its challenges taking approximately two years, including an extensive validation process is a critical aspect. Aspen emphasises the need for adequate resourcing, stakeholder management, detailed process documentation, and sufficient time for training to ensure success.

The Results

Since the commercial launch in July 2020, Aspen’s serialisation system has enabled the supply of compliant products to several export markets. The use of GS1 DataMatrix and EPCIS standards ensures global traceability and addresses the issue of falsified medicines on a worldwide scale.

Conclusion

Aspen Australia’s success story exemplifies the importance of embracing global standards in the pharmaceutical industry. The adoption of GS1 standards has not only facilitated compliance with regulatory requirements but has also strengthened Aspen’s position as a trusted player in the global pharmaceutical market. The lessons learned from this implementation provide valuable insights for other companies navigating the complex landscape of pharmaceutical regulations and traceability.

Learn more about the fight against falsified medicines while enhancing traceability across the supply chain: https://bit.ly/3PjrSyJ