LSPedia 词汇表

An electronic shipping document sent prior to delivery that includes shipment details such as contents, quantities, and shipping identifiers (e.g., SSCCs). Often exchanged in EDI or AS2 formats.

A distributor with a written agreement or ongoing relationship with a manufacturer to distribute its products. ADR status impacts documentation and reporting requirements.

An entity legally permitted under DSCSA to engage in the manufacture, repackaging, distribution, or dispensing of prescription drugs. Verification of ATP status is required for transactions.

A manufacturer-assigned identifier grouping products made under similar conditions. Used for recalls, traceability, and quality control.

A company that manufactures products on behalf of another company. In the pharmaceutical supply chain, CMOs may handle packaging, labeling, and serialization activities under the direction of the brand owner or MAH.

The process of activating a product’s unique identifier and associating it with a specific physical unit, making it valid for commercial distribution.

A unique nine-digit identifier issued by Dun & Bradstreet (D&B) through the Data Universal Numbering System. It is widely used for verifying business entities and is often required for regulatory and trading partner compliance. 

The physical barcode or symbol that encodes product identifiers such as GTIN, serial number, lot, and expiration. DSCSA requires a 2D DataMatrix for most prescription drugs.

Standards used to securely exchange electronic documents such as EPCIS files, EDI transactions, and ASNs between trading partners.

The process of retiring a serialized product’s EPC (a unique identifier) so that the item is no longer tracked within the supply chain. Unlike the “Destroy” process, a decommissioned item ma y still physically exist, but it no longer carries an active serialization record. 

The process of breaking the parent-child relationship in serialization data. This occurs when a “contained” object (such as a serialized unit) is separated from its “containing” entity (such as a case or pallet). 

A trading partner (retail pharmacy, hospital pharmacy, clinic) that dispenses prescription drugs to patients. Must receive and verify DSCSA-compliant traceability data.

The process and record of permanently removing a serialized item from the supply chain, often involving decommissioning of its identifier.

A standardized communication format used for commercial and logistics documents (e.g., purchase orders, invoices, ASNs). Often used alongside EPCIS for DSCSA compliance.

An event formatted according to the EPCIS (Electronic Product Code Information Services) standard, used to record supply chain activities such as commissioning, aggregation, shipping, or receiving. EPCIS ensures that event data can be consistently shared across systems and trading partners. 

An enterprise-wide system that integrates and manages core business processes, including finance, manufacturing, supply chain, sales, and human resources. ERP systems provide a central platform for data consistency and operational efficiency. 

Procedures or EPCIS events that document issues such as shipment discrepancies, suspect product, failed verification, or data errors.

The date after which a product should no longer be used or dispensed. Required on serialized labels and included in the DSCSA product identifier.

A detailed document that defines how a system, application, or component should function. In software and systems engineering, it describes the expected behavior, user requirements, inputs, and outputs, serving as a blueprint for developers and testers. 

A GS1 identifier that uniquely identifies legal entities, trading partners, and physical or digital locations involved in the supply chain.

Refers to the regulations and standards that ensure pharmaceutical products are consistently manufactured and controlled according to quality requirements. In the DSCSA context, GMP supports drug safety by ensuring products entering the serialized supply chain are legitimate, accurately labeled, and produced under controlled conditions. Together with DSCSA track and trace requirements, GMP helps protect patients from counterfeit or substandard drugs.

A globally unique GS1 identifier used to recognize a trade item at any packaging level. GTINs form the base identifier used in serialization schemes such as SGTIN.

The entity that holds the regulatory approval to market a pharmaceutical product. The MAH is ultimately responsible for product quality, safety, labeling, and compliance activities such as serialization, even when work is outsourced to CMOs or third parties.

Software used by pharmacies to manage daily operations such as prescription processing, inventory management, dispensing, billing, and regulatory compliance. A PMS often integrates with serialization and traceability solutions to support DSCSA requirements, including product verification and transaction workflows.

An EPCIS event that records the act of combining items into a larger unit, such as placing serialized units into a case.

Operational statuses indicating that a product is temporarily withheld from distribution (quarantine/hold) or approved for movement (release), often due to verification checks or quality concerns.

An EPCIS event documenting that a trading partner has received serialized products and taken custody.

A trading partner that repackages drug products from the original manufacturer packaging into new configurations. Repackagers must assign new product identifiers.

A GTIN combined with a unique serial number to identify an individual saleable unit. SGTINs are encoded in EPCIS events and on product data carriers.

A GS1 identifier used to uniquely identify a logistics unit such as a pallet or case. SSCCs support aggregation and shipment tracking.

An EPCIS event indicating that ownership or physical custody of a product is being transferred outbound to another trading partner.

A contracted entity that prints labels or applies serialization data on behalf of a manufacturer or packager.

A historical record of all prior transactions for a product, required under earlier DSCSA phases. (Note: this requirement is replaced under enhanced verification rules.)

A DSCSA-required data set that includes product details, transaction dates, and the identities of sender and receiver when ownership changes hands.

An attestation from the trading partner confirming compliance with DSCSA requirements, including authorized trading partner status and handling of non-suspect product.

A unique code assigned to a product or package level to support serialized tracking and authentication. In DSCSA, the UID typically includes GTIN, serial number, lot number, and expiration date.

Directional terms describing supply chain flow. Upstream refers to manufacturers and suppliers. Downstream refers to distributors, dispensers, and end-recipients.

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Software used to manage warehouse operations, including inventory control, receiving, picking, packing, shipping, and integration with serialization or ERP systems. A WMS often consumes or updates serialized data during physical product handling.

A trading partner that purchases prescription drugs and redistributes them to other parties in the supply chain. Must be licensed and authorized under DSCSA.