From “serialization” to “coding” to “track-and-trace,” the pharmaceutical industry is rampant with terms that point to the quest for transparency. The latest of these is “aggregation,” a burgeoning method of data collection aimed at simplifying inventory and the supply chain. While still in its infancy, the technique can help to combat counterfeiting, theft, inefficiencies, and confusion as a whole. Yet, with every new process comes challenges, requiring manufacturers considering aggregation to seek best practices for implementation.
The industry has made unprecedented progress and addressed several challenges to ensure compliance with global pharmaceutical serialization and traceability requirements. While these requirements contain further regulatory milestones on the horizon, manufacturers, distributors, pharmacies, and other parties in the pharmaceutical supply chain must systematically adopt serialization in their normal business operations.
The Drug Supply Chain Security Act (DSCSA) requires creation of an interoperable system by 2023 to facilitate the sharing and gathering of transactional information back to the packaging at the original manufacturer for authorized trading partners or government agents in the event of a suspicious or illegitimate product. How will this system work and what components and governance will be required?
This article explains the challenge the new Russian traceability regulations for the pharma industry, and how all participants in the supply chain must properly prepare to ensure that they become compliant within this new environment.
Russian President V. Putin signed Federal Law No. 488-FZ, which deals with the amendments to the “Principles of State Regulation of Trading Activities in the Russian Federation”. This article outlines the labeling and management of track and trace data requirements of the new law.
Though the timelines may vary, across the globe more and more countries are requiring product identifiers and serialization of prescription drugs — right down to individual salable units.
The FDA issued the first warning letter related to the DSCSA amendments to the FD&C Act. This article takes a look at this warning letter and explains why pharma manufacturers should care.
The FDA announced its intent to establish a pilot program to “share information, current practices, research, and ideas on the feasibility of establishing standardized documentation to be used by members of the pharmaceutical distribution supply chain to convey the transaction information, transaction history, and transaction statement to the subsequent purchaser of a product and to facilitate the exchange of lot level data.” The question for the industry is, should you participate in the pilot program?
Factors to consider as your organization works to conform to the serialization guidelines.
Package integrity is defined as a package’s ability to prevent product loss, maintain product sterility, and in some cases, prevent oxygen ingress or maintain sub-atmosphere headspace pressures.
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