LSPedia Glossary

An external company contracted to handle the storage, distribution, and transportation of finished goods on behalf of another business. While the 3PL manages the products, it does not take ownership of them.

Often referred to as a parent/child relationship, or a serialized container to content relationship, this is the process of establishing a serial number hierarchy by linking the serial number of a container (the "parent") with the serial numbers of the individual items (the "children") it contains. This creates a traceable, serialized relationship between the containing and contained objects, identifying the physical aggregation. Aggregation is always homogeneous, meaning each container holds only one type of product.

A U.S. federal law enacted in November 2013 to enhance the safety and quality of the nation’s drug supply. It was designed to address issues related to drug compounding and supply chain security.

Title II of the DQSA, this law establishes national requirements for tracking and verifying prescription drugs as they move through the U.S. supply chain—from manufacturer to pharmacy. It aims to prevent counterfeit, stolen, or contaminated drugs from entering the market. Signed into law in 2013, the DSCSA replaces varying state-level regulations with a single federal standard for drug traceability and security.

A global GS1 standard that enables companies to capture and share detailed information about the movement and status of products as they travel through the supply chain. EPCIS allows trading partners to exchange data about events—such as when and where a product was shipped, received, or transformed—providing a common, real-time view of product activity across different organizations. This helps improve visibility, traceability, and efficiency in the supply chain. (More at www.gs1.org/epcis)

A set of guidelines for validating automated systems in pharmaceutical manufacturing. It provides a risk-based approach to ensure that computerized systems are designed, implemented, and maintained to consistently produce safe and high-quality products.

A global, non-profit organization that develops and maintains standards to improve the efficiency, safety, and visibility of supply chains across industries. GS1 is best known for its system of standards, including barcodes and product identifiers, which are the most widely used supply chain standards in the world. These standards help businesses around the globe share accurate information and streamline operations.

A framework that defines five levels of serialization and data management within pharmaceutical packaging and supply chain systems. L1 – Devices (e.g., printers, scanners), L2 – Packaging line software, L3 – Site-level control, L4 – Enterprise-level system, L5 – Network-level data exchange with external partners.

Documented proof that a system, equipment, or process can consistently produce a safe, high-quality product. The PQ protocol outlines the procedures used to verify these capabilities, typically through testing with simulated materials or actual products. PQ is an essential component of the GAMP framework.

Serialization is the process of assigning a unique serial number to each saleable unit of a prescription drug. Think of it like a fingerprint for every product—it helps track and trace a drug’s journey through the supply chain.

A system that helps verify the authenticity of serialized products by securely routing verification requests from trading partners (such as dispensers or wholesalers) to the appropriate manufacturer or data source. It manages the exchange of information to confirm that a product is legitimate and meets regulatory requirements, such as those outlined in the Drug Supply Chain Security Act (DSCSA).