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.
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.
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...
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...
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...