Understand the Challenges and Opportunities

Pharmaceutical traceability is the new regulatory reality. Within the next five years, most markets will mandate pharmaceutical serialization at the item-level as a means to enable traceability.

A key enabler of pharmaceutical traceability is the ability of manufacturing, packaging, distribution, dispensing and patient to share information in an interoperable manner.

In fact, FDA as part of the DSCSA legislation outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.

According to FDA guidance an interoperable system “encompasses the ability to exchange product tracing information accurately, efficiently, and consistently among trading partners”. The term “interoperable” appears numerous times in the regulation yet standards for interoperable exchange are still emerging and production-proven methods are non-existent.

Effective interoperability of serialized information illuminates item level activity and enables the manufacturer, distributor, pharmacist, and/or regulator to question the integrity of a package and extract a detailed understanding of authenticity, CGMP, chain of custody, and channel integrity.

Attaining pharmaceutical traceability is a significant challenge to the industry. Efforts to achieve serialized interoperability in a validated, GMP compliant environment and with numerous, virtual partners, throughout the entire supply network. is a daunting mission.

Successful outcomes require participation, consensus, and commitment of diverse stakeholders, supply networks, and trading partners. By working together we can understand best practices and lessons learned from prior traceability efforts.

BrandSure designs, deploys, and validates secure supply chains for life sciences. Our extensive experience with product serialization, packaging, distribution and information systems helps our clients attain compliance and protect their brands.