Preface: In this blog I’m going to assert that “the data associated with the drug and its supply chain transactions is just as important as the drug itself.” Disclaimer: The drug is certainly the most important part in the patient healthcare equation—data has nothing to do with that. BUT… there is a comprehensive data collection and integration reality that is required to get these drugs through the supply chain and eventually to the patients who need them. Ultimately, regulations like the...
Is a deadline an obligation or an opportunity? That’s something many pharmaceutical companies, particularly in the US, are considering right now as they look ahead to November 27, 2023. This is the date when the aggregation of serialized products into serialized cases and onto serialized pallets becomes mandatory in the US—along with the corresponding data that is captured and made available to all stakeholders.Serialization was introduced by the US Food and Drug Administration (FDA) as part of...
It’s almost peak holiday shopping season and consumers are once again on the lookout for that perfect gift. However, this year is unlike any other with the events of the last 18-months putting stress on supply chains around the world.
Do you wish the data across your pharma serialization lines was more accessible?
As someone who has worked in enterprise software for a long time, the “disconnected” nature of packaging line data is pretty incredible. Using Systech as an example, we may see network connectivity from enterprise systems to Level 3 Guardian, but rarely visibility to Level 2 Advisor and Level 1 Sentri.
Essentially, each line is its own island. We need to change that!
Pharmaceutical serialization has been looked upon as a panacea for the rampant global issue of counterfeiting. Now that enforcement data has become available on the US Drug Supply Chain Security Act (DSCSA) and EU Falsified Medicines Directive (FMD), it’s time to analyze the results. Has serialization put an end to counterfeiting?
Spoiler alert. According to the EU IP Office, pharmaceutical counterfeiting has not slowed down but is a growing threat.
Serialization was introduced by governments as a mechanism to protect the pharmaceutical supply chain over 10 years ago. Major serialization mandates in the US, EU and other regions are now live. Now is a good time to reflect back on this massive undertaking and review some “lessons learned”. We say this because serialization isn’t “over” in pharma.
I have written and spoken about global counterfeiting issues many times. Pretty much in every single one, I’ve said something like “if you have a successful product, it will be counterfeited.” Illicit counterfeit rings have infiltrated pharmaceuticals, consumer goods, cosmetics, fragrances, automobile parts, aircraft parts, clothing, footwear, wine, spirits and more. The riches and rewards from producing and distributing counterfeit products in most cases far outweigh the penalties of getting...
Change is afoot, we are entering a new phase of activity within the pharmaceutical sector. The next stage of patient protection is starting to take shape across the industry, and it is a case of going back to the future. Though, no DeLorean, TARDIS or even a hot tub time machine are needed to make this change, we are not going to have hover boards or give cousin Chuck Berry a new sound. Instead of fighting Daleks we are going to wage war on counterfeiters and grey marketeers.
It is one thing to mandate the printing of serialized barcodes on pharmaceutical packaging, and quite another to properly print these barcodes on said packaging to meet compliance.
Indonesia is a country that is a collection of many islands in Southeast Asia. You may not think of Indonesia very often, but you should. Indonesia is the fourth largest country on Earth by population, behind China, India and the United States. It is the 14th largest by land area and the 7th largest when you consider land and water surface. It’s big, and it has been doing well economically for the last decade or so since the government stabilized. And they have a government-run universal health...
