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.
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: