Any company wishing to make use of GS1 standards—including their barcodes, identifiers and data exchange standards—must first obtain a GS1 Company Prefix, or “GCP”. Normally you would obtain a GCP by applying to the GS1 Member Organization (M.O.) in the country where your company headquarters resides, but if you are a pharmaceutical company that makes drugs for the U.S. market, regardless of where you are located, you will need to obtain a special GCP from GS1 US, the GS1 M.O. in the United States.
That’s because currently, drugs sold into the U.S. market must contain a linear barcode that encodes your U.S. Food and Drug Administration (FDA) National Drug Code (NDC). To properly encode that NDC into a GS1 barcode symbol, you must register with GS1 US the GS1 GCP that matches the FDA-assigned Labeler Code that is a part of every NDC. Only GS1 US can assign/register a GCP that matches your FDA-assigned Labeler Code. I explain all of this in more detail in my essay “Anatomy Of The National Drug Code”.
Companies may end up with more than one GCP over time for several reasons. For example, if a drug company is based in Switzerland, merged with another pharmaceutical company in France a few years ago and sells pharmaceuticals globally, they may end up with the following GCPs:
- One issued by the Swiss GS1 M.O. obtained originally by the parent company
- One issued by the France GS1 M.O. obtained through the merger
- One issued by the U.S. GS1 M.O. registered by the parent company for use in identifying drugs sold into the U.S. market
- One issued by the U.S. GS1 M.O. obtained through the merger for use in identifying drugs made by the subsidiary in France and sold into the U.S. market
All of these GCPs have value for the parent company and to maximize that value, the parent company should view these GCPs as enterprise resources and manage them that way. Number allocation based on these GCPs should be managed centrally using a strategy that is designed to maximize the benefit to the whole organization rather than to silos within the company.
WHAT IS A GCP USED FOR?
A GS1 Company Prefix is at the core of “The GS1 System”, a set of standards used globally for identification of products, services, assets, relationships and even documents. These entities are identified in the GS1 System at the class level or at the serialized unit level through numeric “keys”. All GS1 keys use the GCP as their foundation so that each key is uniquely specific to the owner of the GCP on a global basis. Once a company is given the right to use a GCP they are free to define any key using that GCP without fear that they will clash with anyone else’s key, and without additional cost. The remainder of each key is used to hold additional information to identify the target entity. Refer to the GS1 General Specifications for full details (check with your GS1 M.O. or just search for a downloadable copy on the internet).
The GCP can vary between six and ten digits in length in the U.S. and may have a different variation depending on the M.O. making the assignment. The following diagram is just a generalized depiction of that.
Here is a list of GS1 keys that are based on the GCP:
- GTIN (Global Trade Item Number) in 8, 12, 13 and 14 digit flavors, and the serial numbers associated with them when forming an SGTIN;
- GLN (Global Location Number) 13 digits;
- SSCC (Serial Shipping Container Code) 18 digits;
- GRAI (Global Returnable Asset Identifier) 14 digits, first digit is always a zero plus optional serial number up to 16 additional characters;
- GIAI (Global Individual Asset Identifier) up to 30 characters;
- GSRN (Global Service Relation Number) 18 digits;
- GDTI (Global Document Type Identifier) 13 digits plus optional serial number up to 17 additional digits;
- GINC (Global Identification Number for Consignment) up to 30 characters;
- GSIN (Global Shipment Identification Number) 17 digits.
Each type of GS1 key includes a numeric value that is combined with the GCP to form a specific instance of the key. It is the assignment of these numeric values that must be managed in some way. The total length of the key minus the length of the GCP determines how many digits are available to the owner to assign specific instances of the key. These digits represent the “key space” for a given key. The shorter the GCP, the larger the key spaces of each key type will be.
(NOTE: As George Wright rightly points out in his comment below my off-hand formula for calculating the available digits in the key space leaves out the check digit in some keys as well as certain other individual digits in other keys. Please refer to the GS1 General Specifications for the full calculation for each individual key type.)
CENTRAL MANAGEMENT OF GCPs AND GS1 KEYS
Companies of any size will benefit by managing all of their GCPs and GS1 keys in a single location and perhaps through a single database and application. It enables the enforcement of a single corporate strategy for number assignment within each key space and ensures that duplicate values will not be generated and number ranges will not be wasted.
It is not necessary for the central GCP management authority to assign every single value for all of the keys to maintain control. This is particularly true for high frequency assignment keys. For example, the responsibility for assigning specific SSCC values may be delegated to remote systems. Even then, the remote systems should be designed to acquire number ranges from the central system so that the enterprise strategy is maintained. Once a number range is acquired by the remote system it can perform its own assignment of the SSCCs within the allocated range as necessary. When it gets close to exhausting the current range of values it can request the next range from the central authority. For small companies this could be done manually, but for mid to large companies, this should be automated.
Keys that are assigned at low frequencies, like GLN—which would only need a new assignment when a new location is established—or GTIN—which would only need a new assignment when a new product or new variation is introduced—could be done manually even in larger companies. Whether manual or automated, central management of lower frequency keys is even more important than the high frequency keys in my view, to ensure that used numbers are properly kept track of.
Central management of all GCPs owned by a company allows the central authority to minimize the need to acquire new GCPs by maximizing those that are already under their control. A central authority can ensure that the key spaces of each key are fully utilized before either reusing previous values (do so very carefully) or acquiring a new GCP. In most cases these decisions should not be left up to remote business units or you might find that the enterprise possesses many more GCPs than are actually necessary.
Central management of serial numbers associated with GTINs–to form GTIN plus serial number, or SGTINs–should also be controlled centrally whether done individually or through number ranges. This allows the enterprise to make use of a single serial number assignment strategy, including some form of randomization, if desired, like the kind offered by RxTrace advertiser Kezzler.
The introduction of a new GCP through a central authority can be much cleaner and much more efficient than if done otherwise. Remote systems should not make any assumptions about the GCPs within the GS1 keys they are provided, whether individually or within ranges. That way the central GCP authority can introduce the use of new GCPs at any time necessary.
Very large enterprises that make heavy use of GS1 keys might have a group that is dedicated to managing their GCPs and GS1 keys, but most companies will be able to make it fit within a group that is responsible for other data-related activities. Good candidates for the GCP management responsibility within an enterprise are the Master Data Management (MDM) group or some other existing data management group.
Regardless what group the responsibility ultimately falls, central management of your GCPs and associated GS1 keys is a good idea. If your company does not currently have central management, I suggest you start asking questions to find out:
- How many GCPs does your company control?
- Who manages the key spaces of each one?
- Does anyone know exactly which key values have been consumed within each key space of each GCP?
- Who has the authority to acquire a new GCP and for what reasons?
You might be surprised at what you find.
4 thoughts on “Your GS1 Company Prefix: An Enterprise Resource”
You make a subtle but critical point regarding, “GTIN— new assignment when [a] new variation is introduced”.
There are several GS1-defined scenarios that trigger a new GTIN for the “same” product; changes to usage, an updated regulatory filing, etc. The GTIN Allocation Rules (Healthcare) contain specific guidance for OTC and Prescription Drugs.
In practice, is the “overlap” between the GTIN and NDC limited to the GCP? Can you foresee when the assignment and maintenance of the NDC might conflict with the Healthcare GTIN Allocation Rules?
Thanks for your comment. You’ve made an excellent point. In fact, I have made this same point publically before, just not in RxTrace. The GS1 GTIN allocation rules will sometimes indicate the need for a new GTIN based on certain changes to packaging or the product itself, but pharmaceutical companies are unlikely to change their NDC on the product in those instances because the FDA may not mandate it, and because of the cost of introducing a new NDC. For that reason I have expressed concern about the viability of tying a regulated identifier like the NDC to a non-regulated identifier like the GTIN because they have different allocation rules. I have not documented the exact GTIN rules that may fall into this category but it would be an interesting exercise. Perhaps I’ll do that for another essay in the future.
It’s interesting that GS1 has recently created a new Application Identifier called the National Healthcare Related Number (NHRN) which sounds like it would be ideal for holding the NDC in the U.S. and associating it with a global GTIN that isn’t the NDC. However, that might violate the FDA’s linear barcode rule if you placed a barcode on your drug that contains an (01) with a non-NDC GTIN and a NHRN AI indicating an NDC (which isn’t defined…yet). I don’t know. So far GS1 has defined AI’s 710, 711 and 712 for Germany IFA, France CIP and Spain National Code NHRNs respectively. I’ll try to analyze the HNRN in a future essay.
Thanks for making the point.
Thank you for yet another thoughtful and interesting essay. Keep up the good work.
You say that “Once a company is given the right to use a GCP they are free to define any key using that GCP without fear that they will clash with anyone else’s key, and without additional cost.” Your first assertion is certainly true; the GS1 Company Prefix assignment is assuredly unique globally and any “system key” properly derived from it will also be unique.
However, GS1 Member organizations (MOs) around the world assign GS1 Company Prefixes on a subscription basis and charge an annual renewal fee that has to be paid in order to continue to have the right to use the GCP and the GTINs, GLNs, and other unique identifiers associated with it. (Admittedly, this was not the case in the early days of the Uniform Code Council, predecessor to GS1 US.) Today, however, with GS1-US the first year’s fee for the initial assignment is (considered) relatively high but the subsequent annual renewal fees are a fraction of that amount. In other countries, the initial fee can be substantially lower than in the U.S. but the annual renewal fee for many MOs is the same as the initial assignment fee.
A further point concerns the formula for deriving the length of the company controlled segment of a GS1 system key. You write, “The total length of the key minus the length of the GCP determines how many digits are available to the owner to assign specific instances of the key. These digits represent the “key space” for a given key.” However, most of the GS1 system keys incorporate a check digit similar to that used for GTIN-13. For these keys the available “key space” is one less than the formula you give.
Thanks for your comment. All excellent points, and I have added a note in the main essay to explain how my formula fails to accommodate not only the check digit of some keys, but a few other individual digits of certain other keys and that the best way to figure out how many digits are in a given key using your particular GCP is to refer to the GS1 General Specifications. I didn’t mean for this essay to deal with the full calculation because it would have added way too much tedium for readers (and for me) and would have obscured my main point, that companies need to have a strategy for managing their GCPs and associated keys, and that the best approach is to centralize that management. However, that’s no excuse for inaccuracy.
Thanks for keeping me accurate!
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