2022-11-22 | DSCSA interoperability deadline: is your organization ready?

In an interview for the Vantage Solves Series I explained why November 27, 2023 is critical for the pharmaceutical supply chain. By this date members of the ecosystem must implement an electronic, interoperable system to identify and trace prescription drug products in the US to be compliant with the Drug Supply Chain Security Act (DSCSA). Additionally, wholesale distributors will require aggregation data to accept product in the coming year.

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2022-01-12 | At-home coronavirus test kits: the real counterfeiter's dream

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

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2021-12-21 | Pharma brands shouldn’t wait to aggregate

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...

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2021-03-16 | How to Get a Big-Picture View of Your Serialization Lines

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!

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2021-01-05 | Has Global Pharma Serialization Stopped Counterfeiting?

 

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.

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2020-12-15 | COVID Vaccine Counterfeiting Will Be Explosive

 

Liquid Gold. That's how Interpol has described organized crime's view of vaccine demand. The more in demand a product is, the more it will be counterfeited. We can count on an absolute tidal wave of COVID vaccine and treatment counterfeiting to flood the markets now that the vaccine is available.

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2019-11-04 | 2019 GS1 Barcode Assessment Study Results – Pharma Packaging Compliance

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.

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2019-09-10 | Unpacking Indonesia's Pharma Serialization & Traceability Regulations

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...

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2019-07-31 | China Accelerates Pharma Traceability Regulations in New Document

China’s National Medical Products Administration (NMPA) has been very active in the last year, producing documents that address various aspects of their planned pharma traceability mandate. It has been several years since the previous pharma serialization and tracing regulation was suspended. The future system described in the new final guidance documents is significantly different from that old suspended system. Where the old system avoided the use of global standards—and thus it was a...

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2018-10-02 | Reducing the Complexity of Global Pharma Regulatory Compliance

First and foremost, a successful serialization program involves far more than just placing serial numbers on packaging -- regardless of the market. However, pharmaceutical companies that distribute in more than one country face significant regulatory compliance complexity, with each additional market adding another layer of challenges. Regulations differ between markets, and can change often enough meaning regulatory professionals must be prepared to adjust processes, procedures and filings to...

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