glossary with core terms regarding EU MDR and IVDR

[Glossary] Serialization: The terms you should know

 

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

 
3PL—Third-Party Logistics. A contracted company that provides distribution services of finished goods on behalf of another company. A 3PL never takes ownership of the product although the product is in its possession.

Aggregation—The process of recording the serial number of a container along with the serial numbers of its contents; often referred to as a parent/child relationship, or a serialized container to the content relationship.

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.

Batch—A group of products, usually associated with a manufacturing or packaging operation. Also referred to as a lot.

Bundle—A group of items held together, usually by shrink wrap. See also Inner Pack.

Check Digit—Redundancy check used for error detection of identification numbers. Used in NDCs, DEA numbers, GTIN-14 identifiers, and SSCCs, for example.

CMO—Contract Manufacturing Organization. A company providing manufacturing, and sometimes packaging, services for one or more companies based on contracts or service agreements. Also referred to as a Contract Packaging Organization (CPO) or Third Party Manufacturer (TPM).

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

Counterfeit—An imitation usually created with the intent of fraudulently passing it off as genuine, often to take advantage of the established worth of the imitated product. The word counterfeit frequently describes the forgeries of currency and documents, and the imitations of clothing, software, pharmaceuticals, jeans, watches, electronics, and company logos and brands. In the case of goods, it results in patent infringement or trademark infringement.

CSV—CSV Comma Separated Values. A common data exchange format is stored in a tabular format. CSV files can be opened in spreadsheet programs.

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

Encoding—A state for serial numbers. If an organization pre-prints labels for serial numbers after they are provisioned, the serial numbers enter the encoding state. Once the labels are affixed to the products, the serial numbers enter the commissioned state.

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. (More at www.gs1.org/epcis).

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

European Hub—A cloud-based gateway for EU compliance reporting. Provides interoperability between different national systems in the EU, and managing product status (such as decommissioning and recalls) and exceptions throughout the life cycle of a product. The hub doesn’t store serialization data like a repository – instead, it acts as a single point of entry.

Expiry—Date of expiration for an item, or the last day the item should be used.

Extension Digit—A one-digit segment used to extend the serial reference segment of an SSCC identifier.

External Product Identifier—A standards-based product code, such as a 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.

FMD—The Falsified Medicines Directive. A pan-European directive also referred to as EU FMD, intended to protect patients from counterfeit medicines in the legal distribution chain. The European Medicines Verification System (EMVS) was developed to implement the FMD.

GCP—Global Company Prefix. A globally unique code that is used to represent a location in identifiers. See also GS1 Company Prefix.

GLN—Global Location Number. A unique 13-digit number containing a GS1 company prefix, a location reference, and a check digit, used to uniquely 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.

Global Identifier—A unique reference number used to identify a legal entity such as a company or location, to support the secure exchange of business information on the Internet.

GS1—A leading global organization dedicated to the design and implementation of global standards and solutions, to improve the efficiency and visibility of supply and demand chains globally and across sectors. The GS1 system of standards is the most widely used supply chain standards system in the world. (More at www.gs1.com).

GS1-128—A linear barcode, formerly referred to as a Code-128 barcode. Usage is granted to organization members of GS1.

GS1 Company Prefix—A globally unique identifier for a company, assigned and administered by GS1 Global. The GS1 Company Prefix is 4 to 12 digits and is a component of GLN, GTIN, and SSCC identifiers.

GS1 Datamatrix—A two-dimensional matrix barcode consisting of black and white “cells” or modules arranged in either a square or rectangular pattern. The information to be encoded can be text or raw data. Usage is granted to organization members of GS1.

GTIN—Global Trade Item Number. An identifier for trade items, developed by GS1. Such identifiers are used to look up product information in a database, often by inputting the number via a barcode scanner pointed at an actual product. The uniqueness and universality of the identifier are useful in establishing which product in one database corresponds to which product in another database, especially across organizational boundaries. Usage is granted to organization members of GS1.

Inspection—The process of reviewing an item, either manually or using automated systems.

Internal Material Number—A number assigned to a product for internal use and not for identifying the product externally.

Interoperability—The ability of technology systems and software to communicate, exchange data and/or information, and make use of the information that’s been exchanged.

IQ—Installation Qualification. Demonstrates that a process or equipment meets all specifications, is installed correctly, and that all the required components and documentation needed for continued operation are installed and in place.

Item—The product secondary package level, typically a carton. Also referred to as the smallest saleable unit.

L1 – L5—The 5 levels of serialization and information management: L5 – Network-level serialization system, L4 – Enterprise serialization system, L3 – Site-level serialization, L2 – Packaging line software, L1 – Device.

LMS—Line Management System. A system that manages a production line and interfaces with a company’s Enterprise Resource Planning (ERP) system.

Logistic Labeling—Comprises the data and process of printing labels for use on all containers above the secondary packaging level. For example, shipper and pallet labels.

MAH—Marketing Authorization Holder. The license holder (brand owner) of a pharmaceutical product. Manufacturer An entity or organization is responsible for the packaging of the product.

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

MES—Manufacturing Execution System. A control system for managing and monitoring work-in-process on a factory floor.

National System—An information system set up and governed by national stakeholders to ensure a medicine’s authenticity by verifying its safety features, to prevent falsified products from entering the supply chain.

OEE—Overall Equipment Effectiveness. Evaluation of the effectiveness of a manufacturing operation.

Packaging and Labeling—Generally, related to the physical material, artwork, and printing that’s used with all levels of product and logistics containers.

Pallet—A flat transport structure (sometimes called a skid) that supports goods in a stable fashion while being lifted by a forklift, pallet jack, front loader, or other jacking devices. A pallet is the structural foundation of a unit load, which allows handling and storage efficiencies. Goods or shipping containers are often placed on a pallet secured with strapping, stretch wrap, or shrink wrap, and then shipped.

Parallel Importer—An organization that buys a product on the open market with the intention to repackage or relabel, and then distributes it outside the network that’s set up by the manufacturer or that manufacturer’s authorized distributor.

PQ—Performance Qualification. The documented evidence that a system, equipment, or process is capable of consistently producing a safe product of high quality. Performance Qualification protocol describes the procedures that verify the specific capabilities of a process equipment/system through the use of simulation material and/or actual product.

Primary Package—Primary containment system in which the product is sterilized (excluding shelf cartons and shipping containers) that protects the contents to the intended level over a specific period of time.

Product Code—A unique identifier assigned to each finished manufactured product that is ready to be marketed or sold. Also known as Universal Product Code, a common barcode used to identify packaged products.

Recall—The removal of a drug product from the market.

RFID—Radio-Frequency Identification. The use of an object is typically referred to as an RFID tag, applied to or incorporated into a product, animal, or person, for the purpose of identification and tracking using radio waves.

Safety Features—Elements, such as anti-tampering devices and barcodes carrying product and pack data, that are incorporated into a medicine product’s packaging and identification to facilitate verification. Under FMD, for instance, safety features contain a) a unique identifier encoded in a 2D barcode, and b) anti-tampering technologies.

SDB—Serialization database. A level 4 serialization system.

Segment—Part of a market or industry. The pharmaceutical supply chain includes segments such as manufacturer, wholesaler, dispenser, Contract Manufacturing Organization (CMO), Third-Party Logistics (3PL) companies, and repackagers (also known as Third-Party Packagers or 3PPs).

Serial Number—Typically a portion or component of a Unique Identifier (UID) which provides uniqueness. Also known as a serial reference.

sFTP—Secure File Transfer Protocol. A network protocol that provides file access, transfer, and management over a secure channel.

SGLN—Serialized Global Location Number. A unique identifier to a physical location, such as a specific building or bin within a warehouse. The GLN is a GS1 format; the SGLN is an EPC format and is represented in Uniform Resource Identifier format, for example, urn:EPC:id:sgln:0030001.12345.400.

sGTIN—Serialized Global Trading Item Number. The combination of a Global Trade Identification Number and a serial number uniquely identify an item.

Site Server—A computer system located in a specific locale responsible for a location-specific function. In traceability systems, site servers usually refer to local servers which allocate serial numbers to packaging control systems and/or manage serial number information before it is transmitted to an enterprise traceability event repository.

SKU—Stock Keeping Unit. Specifies a distinct type of item for sale. SKUs are not regulated or standardized and thus are not used for serialization.

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

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

SOAP—Simple Object Access Protocol. A messaging protocol for exchanging structured (XML) information in the implementation of web services.

SSCC—Serial Shipping Container Code. A GS1 standard is used in logistic encoding and communications. The SSCC ensures that logistic units are identified with a number that is unique worldwide.

TPO—Third-Party Organization. The term is used to refer to any TPM, 3PL, CMO, or other externally contracted organization.

Track and Trace—The process of tracking drugs through the supply chain using serialization data. Track and trace systems begin with serialization but generally include additional components such as product tracing or tracking, verification, and/or reporting.

UID—Unique Identifier. A string of numbers and characters that is unique within a given system. Examples include GS1 GTIN and GS1 SSCC identifiers.

UPC—Uniform Product Code. The U.S. standard article number. A form of GTIN data carrier or barcode.

Upstream—The opposite direction that product flows in a supply chain; moving back up the supply chain. Generally speaking, the pharmaceutical product flows, and transactions occur, through the supply chain from manufacturers, to repackagers, to wholesaler-distributors, to dispensers.

User—An entity, individual, or organization responsible for making use of products, processes, or systems.

Validation—Documented procedure for obtaining, recording, and interpreting the results required to establish that a process will consistently yield product complying with predetermined specifications.

Virtual Manufacturer—A company that outsources services to a manufacturer/CMO.

Wholesale Distributor—A company that distributes drugs to an entity other than a consumer or patient.

WMS—Warehouse Management System. A software application that supports the day-to-day operations within a warehouse. A WMS enables centralized management of tasks such as tracking inventory levels and stock locations.

WSDL—Web Service Definition Language. An XML-based interface is used to describe the functionality of a web service.

XSD—XML Schema Definition. Describes the structure of an XML document

Pharma Serialization, Aggregation and Track and Trace Software by SoftGroup Top

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