Scientists Working in The Laboratory

A-Z of labeling terminology

The world of regulated label management has its share of highly specialized, technical language. This glossary is intended to give an overview of the most commonly used terminology, with links to further information to help bring you up-to-speed.

  • AIDC (Automatic Identification Data Capture): Refers to the methods of automatically identifying objects, collecting data about them, and entering them directly into computer systems, without human involvement. A very common form of AIDC is a barcode.
  • Annex VI: Annex 11 is the European guidance system for electronic records and electronic signatures in the pharmaceutical industry and is the equivalent to the USA’s FDA 21 CFR part 11. This annex applies to all forms of computerised systems used as part of a GMP regulated activities. Watch the webinar.
  • Artwork management system: System used for label artwork design and layout. Usually comprised of illustration, page layout, image manipulation and PDF editing software.
  • Barcode: A sequence of bars and spaces that translates data into a machine-readable format.
  • Cloud labeling solution: A cloud-based rather than on-premise solution, which gives companies more flexibility over how they manage their label and content management processes. Read more.
  • Commercial-off-the-Shelf software (COTS): Software that is ready to use without customization, though it can have configurable aspects.
  • Country Specific Labeling: Information added to the product packaging that contains information specific to a shipping destination/country of use, not present on the primary product labels.
  • eIFU: Electronic version of a medical products Instructions for Use, typically made available on the company product website for viewing/download.
  • EU CTR 536/2014: The EU Clinical Trial Regulation (536/2014) is scheduled to replace the European Clinical Trials Directive (2001/20/EC) later this year. It includes detailed safety provision assessments, indemnity provisions and measures to support multi-national clinical trials.
  • EU MDR: The new EU Medical Devices Regulation came into effect on 26 May 2021 and has a number of implications for medical device labeling. Read more.
  • FDA 21 CFR Part 11: A regulatory measure allowing medical device and clinical trial organizations to use electronic records and signatures in place of paper-based documentation under certain criteria. Read more.
  • GAMP V: A set of principles of procedures to ensure medical products meet required quality standards across every stage of the manufacturing process.
  • Global Labeling System (GLS): a labeling system developed to operate and standardize across multiple territories and regulatory environments.
  • GS1: The international organization that oversees a system of globally recognized open standards for unique identifiers, such as barcodes that can be used throughout the supply chain to enhance traceability. Read more.
  • GTIN: Global Trade Item Number refers to the data string contained in a barcode that identifies the manufacturer, package level/configuration, product code and check digit.
  • GxP: The combined guidelines and regulations in place to ensure pharmaceutical and medical device products adhere to quality processes throughout the product journey.
  • HIBC - Health Industry Barcode Standard that grew out of a task force hosted by the American Hospital Association and composed of numerous other health care trade organizations.
  • Instructions for Use (IFU): Instructions provided with a healthcare product for safe and effective use.
  • IQ/OQ/PQ: Three key levels of quality checks within pharmaceutical manufacturing. IQ stands for Installation Qualification and ensures the installation is correct; OQ is for Operational Qualification and checks the product or application is working using test data; and PQ is Performance Qualification which establishes that the product or application, under real life conditions, consistently produces products that meet all predetermined requirements. Read more.
  • Label reconciliation: The process of ensuring all labels issued have been used, destroyed, or removed from the production line to prevent label mix-ups between product lots.
  • Label validation: The process of checking that the design, content and printed form of a label conveys the intended information.
  • Label verification: Confirmation that label is correct and legible during distribution and storage.
  • Line Scanner: Hardware used to scan and capture printed label for inspection purposes. In the labeling context typically attached to a printer to capture image immediately after the print head.
  • SaaS labeling solution: Software as a Service/cloud-based labeling solution.
  • UDI: The Unique Device Identifier is a system to allow the easy recognition of products enabling traceability from manufacturing to distribution to patient use – a key element of regulatory compliance for medical device manufacturers trading in the US and Europe. Read more.
  • Validation: Validation is the process of establishing documentary evidence that a procedure, process, or activity carried out in testing and then production maintains the correct level of compliance at all stages. Read more.
  • Vision inspection : Automated system used to verify a printed label to a pre-approved template. Watch the webinar.

 

 

This article was published on August 6th, 2021