Product identifiers are the backbone of serialization, and therefore a critical part of DSCSA compliance and a topic front-of-mind for most pharma manufacturers and wholesalers. We’ve discussed the topic before (both as a serialization issue more broadly and in relation to the HDA’s Origin GTIN repository solution), but this week we wanted to examine one specific identification system in detail to understand its parts, and its strengths and weaknesses.
What is a GTIN?
GTIN is the acronym for Global Trade Item Number. It is a globally unique number given to an item in the supply chain that identifies the product from manufacturing through distribution and use. A GTIN is made up of 14 digits: an indicator digit, the GS1 company prefix, the Food and Drug Administration (FDA) NDC number, and a check digit. A GTIN can be used at all packaging levels, including item, inner pack, case, or any other packaging configuration.
What components make up a GTIN?
The 14-digit GTIN has five major components. I’ll mark them A, B, C, D, and E as illustrated below.
- Indicator: This is also known as the “packaging indicator” and is found in position 1 in the diagram as shown below. The indicator is used to identify different pack configurations of the same product. It takes a value of 0 to 8 (number 9 is reserved for variable measure items) and is used for lower or higher packaging levels. The simplest way to allocate the indicator is sequentially—that is 0, 1, 2, 3— to each grouping of a trade unit.
For example, a single carton or a bottle may have an indicator of “0” (item level).
A bundle can have an indicator of “3” (inner pack level).
And a case can be an indicator of “5” (shipper level).
[Note: Pallets do not use GTINs; they require a Serial Shipping Container Code (SSCC)]The next 12 digits are a combination of your GS1 company prefix, the product’s code and the packaging code. Let’s take a look:
- GS1 Authorized Company Prefix. This is a globally unique code issued by GS1 (the organization that develops and maintains global standards for business communication) that allows you to start using GS1 identification standards. To get a GS1 company prefix you must apply for it with GS1.The length of the company prefix can vary from 6 to 9 digits long.
- NDC Product Code. The product code is part of the National Drug Code (NDC), and it identifies the specific strength, dosage form (i.e, capsule, tablet, liquid), and formulation of a drug for a specific manufacturer.
- NDC Package Code. The package code is also part of the NDC and it identifies package sizes and types.
- Check Digit: The check digit—the number on the far-right side of a barcode—is used for error detection and to verify that the information on the barcode has been entered correctly. It consists of a single digit that is computed from all the other digits in the barcode based on a specific mathematical algorithm. (Refer to the GS1 check digit calculator to generate check digits.)
GTIN Master Data
Together, the five components of a GTIN ensures that each instance is a truly globally unique item number. In addition, it encompasses the packaging code, therefore separating unit, inner pack, and case, and giving each its own individual identity.
In the DSCSA statue, the FDA requires manufacturers to affix or imprint a product identifier that contains the NDC number. The construction of the 14-digit GTIN fulfills the FDA DSCSA requirement.
Because wholesale distributors have aligned behind this standard, GTINs are without question the “new master data.” That means trading partners need to create their master data internally and take the necessary steps to exchange master data. Only after those steps is it possible to trade serialized products.
How LSPediA Can Help You Meet Serialization Compliance Standards
Acquiring and coordinating product identifiers is just one part of complying with DSCSA serialization guidelines. We ensure all those elements come together for our clients, providing guidance and strategies for every step in the process. By working with LSPediA, you’ll benefit from:
- More efficient business processes
- A better return on technology investments
- Improved regulatory compliance
- Higher customer satisfaction
About LSPediA – Life Sciences Solutions
LSPediA is a leading provider of services and solutions that secure supply chains, protect against product counterfeiting, and help businesses comply with FDA regulations. Our customers are partners in the pharmaceutical supply chain, including manufacturers, wholesale distributors, dispensers, and reverse logistics providers. LSPediA helps customers define needs and implement best-of-breed supply chain and enterprise solutions that improve efficiency and comply with FDA and global standards.
We value long-term relationships and work with our clients’ internal teams to properly define roadmaps, create architectures, and implement systems that align to vital business goals. Our expertise, experience, and technical know-how help customers derive maximum value from their investments, both now and well into the future.
For additional information, contact: Julianne Jahn [email protected]