Tag Archives: GTIN

Last week I published an essay that gave GS1 some advice on how to trigger interest in adoption of their Global Data Synchronization Network (GDSN). Those of you who read that essay in the first two days read my snarky comments about GS1 seemingly attempting to commandeer the term “Data Quality” to include the need for GDSN. That was based on a mis-interpretation of their marketing materials for their “Data Quality Framework” and as soon as I discovered my mistake I removed that part of the essay, leaving the core point of the essay intact (see “An Open Letter to GS1, RE: GDSN Marketing”).

In fact, GS1 is saying exactly the opposite of what I originally thought regarding Data Quality and GDSN. That is, before you start publishing your supply chain master data (SCMD) through GDSN you should ensure that the quality of your data is high. As GS1 points out, “Good quality data is foundational to collaborative commerce and global data synchronisation.” I couldn’t agree more.

The GS1 Data Quality program is centered on the “Data Quality Framework”, which is Continue reading Before You Sign Up For GDSN, Get Your Data In Order With A Data Quality Program →

WMS

The Serial Number Handling In Your WMS Probably Isn’t Sufficient For Pharma Serialization

April 30, 2012 Dirk Rodgers 2 Comments

Most Warehouse Management Systems (WMS) available on the market today do a fine job of allowing their users to manage inventories in the warehouses of drug manufacturers, distributors and chain drug stores. A WMS is a software system that may be a part of a larger Enterprise Resource Planning (ERP) system, or it may be a third-party application that is interfaced with the owner’s ERP system.

All WMS systems that I am aware of are intended to be sold into multiple industries, not just in pharma. That’s so that the WMS vendor can maximize their sales. The more industries, the more sales and the more profitable it is. Because some industries have long had serial numbers on some of their products (computers and peripheral equipment, cell phones, electronics, medical equipment, appliances, etc.) WMS vendors have included serial number handling in their software for decades. In fact, I would bet that a serial number handling feature was included in WMS systems since the very beginning of that category of software.

However, buyers of WMS systems in the pharma supply chain should be very careful not to confuse a “serial number handling” or even “serialization” checkbox on the WMS vendor’s spec sheets with the kind of “serialization” they will need for compliance with modern pharma serialization regulations. I include Continue reading The Serial Number Handling In Your WMS Probably Isn’t Sufficient For Pharma Serialization →

GS1 Company Prefix

Your GS1 Company Prefix: An Enterprise Resource

April 23, 2012 Dirk Rodgers 4 Comments

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 Continue reading Your GS1 Company Prefix: An Enterprise Resource →

Pedigree models, standards, Uncategorized

GS1 Standards – Betcha Can’t Use Just One!

April 2, 2012 Dirk Rodgers 3 Comments

The title is a paraphrase of a TV commercial from the 1960’s, ’70’s and ’80’s for Lay’s Potato Chips but the sentiment is the same. You really can’t get away with using only a single GS1 standard. That’s why they are sometimes referred to as “The GS1 System of Standards“. It’s a “system” of standards. Multiple standards that are designed to work for you together in concert; as a whole; not independently.

So when your customer demands that you make use of Global Location Numbers (GLN) and/or Global Trade Item Number (GTIN), they are starting you down the path of adoption of much more than just those two “entry-level” standards (see my essay “So a customer demands that you use GLN’s and GTIN’s. What next?”). Here is a partial list of other GS1 standards that you may benefit from adopting once you fully embrace GLN and GTIN: Continue reading GS1 Standards – Betcha Can’t Use Just One! →

Counterfeit Drugs

How Counterfeit Avastin Penetrated the U.S. Supply Chain

February 20, 2012 Dirk Rodgers 20 Comments

counterfeit Avastin 400vial packaging — Counterfeit Avastin

The internet lit up last week when the U.S. Food and Drug Administration (FDA) posted an announcement that they are aware of counterfeit Avastin in the U.S. pharmaceutical supply chain (see “Counterfeit Version of Avastin in U.S. Distribution” on the FDA website and Genentech’s announcement).

I found out about it when I received notice of Dr. Adam Fein’s (PhD) excellent blog posting “Greedy Physicians Invite Fake Avastin Into the Supply Chain” on his DrugChannels.net blog, but multiple national news agencies picked the story up and many articles were written about it. Most simply reflected the contents in the FDA’s announcement.

But at least one news source seemed to do some additional investigating. Bill Berkrot and John Acher of Reuters published the excellent article “Fake Avastin’s path to U.S. traced to Egypt” on Thursday. In the article they provide a little more background on the path the drugs allegedly took before apparently arriving on the shelves of U.S. physicians and potentially in the bodies of unsuspecting U.S. patients.

And Pharmaceutical Commerce Online reports that Avastin isn’t the only incident of recent counterfeit injectable cancer drugs making it into the U.S. market that the FDA is currently investigating.

HOW COUNTERFEIT AVASTIN MADE IT INTO THE LEGITIMATE U.S. SUPPLY CHAIN

Now keep in mind, this is only investigative journalism so far, and while the information source listed in the Reuters article is the Danish Medicines Agency, criminal investigators may already know more than this and in the end, some or all of the contents of the Reuters article may eventually be found to be untrue. Whether ultimately true or not Continue reading How Counterfeit Avastin Penetrated the U.S. Supply Chain →

Barcodes

Why NOW Is The Time To Move Away From Linear Barcodes

February 13, 2012 Dirk Rodgers 9 Comments

Linear barcodes have served us well for almost half a century, but NOW is the time to move on to something else in the global pharmaceutical supply chain. I think most people already agree with that but I’m not sure everyone fully appreciates exactly why that is. It’s important to fully understand the reason why so that your resolution to move away from linear barcodes is strong and you won’t drag your feet or look back. So let me show you.

SERIALIZATION
THE DAWN OF ^ ~~CIVILIZATION~~

No matter what you might think is going to happen to ePedigree or track & trace regulations going forward, more and more governments around the world are concluding that legitimate pharmaceuticals should come with unique identifiers—serial numbers—attached to them by the manufacturers and repackagers.

Serialization is upon us and I believe that in 10 years the ongoing benefits from it around the globe will significantly exceed the ongoing costs. Whether you agree to the benefits or not you certainly must accede to the fact that Continue reading Why NOW Is The Time To Move Away From Linear Barcodes →

SNI

Anatomy Of An FDA SNI

January 30, 2012 Dirk Rodgers 2 Comments

The U.S. Food and Drug Administration (FDA) published their “Standardized Numerical Identification (SNI) for Prescription Drug Packages – Final Guidance” document almost two years ago (see my essay “FDA Aligns with GS1 SGTIN For SNDC” from back then). The guidance was published as purely non-binding recommendations that reflected the Agency’s current thinking, but in my opinion it is a nice piece of work and can be used as a practical guide, as far as it goes, for implementing drug serialization programs today.

Why is that? It’s because drug manufacturers and repackagers need to serialize all of their prescription drugs that enter the state of California in 2015/2016. Can those companies make use of the FDA’s SNI guidance to comply with the serialization requirements of the California Pedigree Law? I will answer that question in this essay, but first Continue reading Anatomy Of An FDA SNI →

standards

Depicting An NDC Within A GTIN

January 23, 2012 Dirk Rodgers 1 Comment

In recent essays I have covered the “Anatomy of an NDC”, the “Anatomy of a GTIN” and the “Updated HDMA Bar Code Guidance: A Must Read“. Now let’s put them all together. Why would we need to do that? Because the U.S. FDA requires many Over-The-Counter (OTC) and all prescription drugs marketed in the United States to have their National Drug Code (NDC) presented in the form of a linear barcode on the package. Pure and simple. To do that in a way that your trading partners can understand—that is, to do it interoperably—you need to follow a standard. You have two realistic choices for standard approaches to this problem: HIBCC or GS1.

The use of HIBCC standards is fairly common in the U.S. medical surgical devices supply chain but in the pharmaceutical supply chain it is very rare. Most companies choose GS1’s barcode standards so that’s all I’m going to focus on in this essay. If you want more information Continue reading Depicting An NDC Within A GTIN →

…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance