In March of 2020, we knew so much less than we do now about COVID-19. One thing we did know, however, was that testing would be a critical element in fighting the pandemic. Testing sites were established around the globe, with unprecedented demand. It was completely predictable that the “bad guys” would look to profit by introducing counterfeit tests into the market. And they did. I wrote about it then: https://blog.systechone.com/blog/counterfeit-coronavirus-covid19-tests
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...
When you start a company, your goal is to create a popular and profitable product. You are decidedly not thinking about the fact that your product will get counterfeited and sent to the gray market when it does get popular. And trust me, that will happen.When I met with the American skincare brand OZNaturals® they were riding the wave of rapid growth and impressive success. The company was launched in 2013 by CEO Angela Irish with the goal of creating a range of clean, efficacious, and...
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 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.
Drug repackagers face unique challenges under the Drug Quality and Security Act (DQSA), driven by their distinctive position in the pharmaceutical supply chain. One major US drug repackager needed a solution with a wide breadth of features and comprehensive configurability to get in compliance with DQSA so they reached out to Systech for assistance.
A few months ago, the government of the Russian Federation adopted Order Number 791-r, which appears to have significance for pharma serialization there. The primary deviation from the pharma serialization specification that has dictated the government pilot in Russia since early 2017 is the addition of two new data elements to the datamatrix barcode on secondary packaging. For the pilot, the datamatrix barcode contained:
Last month, GS1 US published a report on a DSCSA barcode assessment they conducted last year with two of the largest wholesale distributors in the US, AmerisourceBergen and McKesson. The goal of the assessment was to take a “snapshot” of pharmaceutical manufacturer progress toward meeting the serialization requirement of the Drug Supply Chain Security Act (DSCSA) by analyzing drug packages actually in the market.
Pharmaceutical manufacturers are working non-stop to get the serialization systems in place necessary to meet the USA DSCSA mandate going live this November, and the EU FMD mandate going live the following February of 2019. If serialization projects aren’t in full flight at this time, there is a significant chance that a manufacturer will not meet the deadline, not be compliant and not be able to distribute product in those geographies.
President of the Russian Federation, Vladimir Putin, signed a new law the last week of December 2017 that is important for pharmaceutical manufacturers distributing products to or manufacturing in Russia. It establishes January 1, 2020 as
