glossary with core terms regarding EU MDR and IVDR

[Glossary] DSCSA 2023: The terms you should know

 

All terms regarding DSCSA that you need to know are here:

 

ADR

Authorized Distributor of Record. A wholesale distributor that a manufacturer designates or authorizes to distribute its products.

 

ASN

Advanced Ship Notice. A notification of pending deliveries, usually in an electronic format. ASN is the common name for the EDI 856 transaction.

 

Authenticate

The practice of checking a unique identifier against a set of captured serialized data to determine its authenticity.

 

B2B

Business-to-Business. Interactions that support the transfer of standardized interchange files up to an enterprise`s EDI system. B2B interactions are not integrated with manufacturing, warehouse, or other backend business systems.

 

Case

A container of product cartons which may or may not be bundled.

 

Chargeback

A difference in expected vs. unexpected cost that must be reconciled and reimbursed. For example, when a wholesale distributor charges a manufacturer for cost and labor when a product does not meet agreed business specifications (box size, position, on time, or labeled, for example). A chargeback may also be warranted when a customer buys products at a cost that is less than the distributor`s cost.

 

Commission

Process of associating a unique identifier to a particular object (product, shipment, asset, or container).

 

Cycle Counting

The periodic (daily, monthly, annual) manual counting of inventory in order to verify what quantities are in the warehouse against a business system to determine a financial value. Some edge solutions have a counting capability for lot count that gets bundled as part of a serialization solution to expedite cycle counting.

 

DC

Distributor Center. A warehouse stocked with goods to be redistributed to retailers, wholesalers, or customers.

 

DQSA

The Drug Quality and Security Act. Federal legislation passed in November 201. DSCSA is a section of DQSA.

 

DSCSA

The Drug Supply Chain Security Act, which is Title II of DQSA mandates a full supply chain traceability system from pharmaceutical manufacturer to pharmacy dispenser for prescription drugs being distributed in the United States. The law was signed by President Obama in November 2013, providing a national standard for drug security and replacing the patchwork of state-level pedigree regulations that were in place.

 

Decommission

The process of removing a unique identifier from a product or container so it is no longer tracked. Unlike the business process known as destroying, the item may still physically exist after decommissioning even though it no longer carries serialized identification.

 

Disaggregation

Removing products or containers from their associated parent container. The serial numbers of contained items are no longer associated as children of the parent container.

 

Disposition

The state of a serial number, such as commissioned or decommissioned.

 

EDI

Electronic Date Interchange. The electronic transfer of data between computer systems in a standardized message format.

 

EPC

Electronic Product Code. A unique number that identifies a specific item in the supply chain. Also known as a serial number.

 

EPCIS

Electronic Product Code Information Services. A GS1 EPCglobal standard designed to enable EPC-related data sharing within and across enterprises. This data sharing is aimed at enabling participants in the EPCglobal Network to obtain a common view of the disposition of EPC-bearing objects within a business context.

 

ERP

An Enterprise Resource Planning system. Business process management software used to manage and automate back-office operations.

 

Edge Data

Data captured on a scanning device at different operational hand-off points (edges) of an enterprise, often to determine the status of a product in the supply chain. Examples include capturing products or carton data at a shipping or receiving dock or at the point of dispensing a drug to a patient in a hospital/clinical setting.

 

Edge Solution

A software solution configured with a company`s scanning devices to capture information about physical product as an extension of existing WMS and ERP systems to provide instantaneous feedback and identify and correct potential exceptions. An edge solution can be used to capture a unique product identifier and communicate with serialization repositories to verify a serial number.

 

Exception Management

Defines how warehouse operations address exceptions to business processes such as shortages, overages and damages.

 

Exclusive Distributor

A wholesaler distributor that directly purchased a product from a manufacturer or other channel and is the sole distributor of that manufacturer`s product to a subsequent repackager, wholesale distributor or dispenser.

 

External Product Identifier

A standards-based product code, such as Global Trade Item Number (GTIN), or a market-specific product code used to identify the product in the external supply chain. This is specifically not a manufacturer SKU, which is not regulated or standardized.

 

GLN

Global Location Number. A unique 13-digit number containing a GS1 company prefix, a location reference, and a check digit, used to identify a physical location or legal entity in the supply chain. The GLN makes possible the unique and unambiguous identification of those locations and entities.

 

HAD

Healthcare Distribution Alliance. The national association in the U.S. representing primary, full-service

 

Homogeneous Case

A sealed case containing only product with a single national Drug Code (NDC) and a single lot. Under DSCSA, a homogeneous case produces by a packager must display a unique product identifier that corresponds to the product it contains.

 

Inference

The technique of assuming the serial numbers within a sealed container based on previous observation, and not by directly reading each serial number. Inference is accomplished using data systems or documents and is controlled through validated procedures.

 

Interoperability

The ability of technology systems to exchange information accurately, efficiently, and consistently in a usable format.

 

LPN

License Plate Number

 

Master Data

Data representing a company`s global identifiers, products, and trading partners. Particular types of data are required for serialization and global compliance reporting.

 

Pick-Pack-Ship

The warehouse process of fulfilling an order. Options include picking by order/sequence until complete or verifying at pick by using a scanning-enabled system such as a WMS or edge solution to scan and confirm correct products and quantities.

 

Putaway

The activities that occur between the time that product is received at the warehouse and when it is stocked in inventory.

 

RMA

Return Material Authorization. Initiates the business process of returning product due to damage, incorrect quantity, or other order fulfillment exception for the purpose of refund or replacement.

 

Relabel

Product may be re-labeled if it is being repackaged or being distributed under a different trade name. For wholesalers, relabeling is usually the result of damage to the original label or assigning a new serial number to a container to preserve existing aggregations.

 

Repackager

The business of repackaging involved taking originally manufactured product, and then repackaging or relabeling it for resale in the supply chain. Under DSCSA, any U.S. wholesale distributor that purchases drugs from a repackager on or after November,2018, must ensure that the packages are properly serialized.

 

Replenishment

The manual process of restocking warehouse inventory when a WMS indicates low supply. Automated replenishment through edge solution integration with a company`s WMS can be implemented to boost both floor efficiencies and back-office warehouse management processes.

 

SNI

Standardized Numerical Identifier. A standard identifier affixed to a prescription drug package.

 

SSCC

Serial Shipping Container Code

 

Saleable Return

Product that may be resold once the products identifier has been verified against a pharmaceutical manufacturer`s data.

 

Shipping Verification

The process of verifying the contents of an order against the icking ticket to ensure accuracy prior to shipping the order.

 

Smallest Saleable Unit

Each individual package of drug product, also known as the primary package level. The sealed homogeneous case in which smallest saleable units are packaged is the secondary package level.

 

T3

Under DSCSA, the combination of Transaction Information (TI), Transaction History (TH), and the Transaction Statement (TS) for a drug product as it moves through the drug supply chain.

 

TH

Transaction History. A record of transaction information for each change of wnership within the supply chain, starting with the manufacturer.

 

TI

Transaction Information. A comprehensive set of details about each prodcust included in a transaction, including product name, National Drug Code (NDC) number, strength and dosage form, size and number of containers, lot number, date of transaction, and the names of companies involved in the transaction.

 

TS

Transaction Statement. A statement confirming that trading partners are authorized by law to transfer ownership of product, have received transaction documentation, have systems in place to comply with verification requirements, and did not knowingly ship suspect product or provide false information.

 

UID

Unique Identifier. A string of number and characters that is unique within a given system.

 

VAWD

Verified-Accredited Wholesale Distributors. An accreditation for pharmaceutical wholesale distribution facilities. VAWD accreditation indicates that a wholesale distributor is in compliance with state and federal laws as well as the U.S National Association of Boards of Pharmacy`s VAWD criteria.

 

VRS

A Verification Router Service helps facilitate the verification of a Procduct Identifier under DSCSA by capturing verification requests and routing them to a system of record that contains product information provided by a manufacturer or repackager.

 

Verification Request

A request to verify a product identifier for a pharmaceutical pack affixed by the manufacturer or repackager against a pharmaceutical manufacturer`s data.

 

Wholesale Distributor

A licensed company that purchases (takes ownership of) products from a supplier and then sells them to an entity in the supply chain other than a consumer or patient.

Pharma Serialization, Aggregation and Track and Trace Software by SoftGroup

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