Executives worry a lot, especially in our industry. But even more so in recent years, given the rapid changes in pharma and the looming compliance requirements in the Drug Supply…
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If you’re free March 6-9, and your company is thinking about DSCSA compliance and serialization, I hope you’ll join us at the Distribution Management Conference and Expo (DMC), presented by…
A long and complex drug supply chain is rife with vulnerabilities. A recent recall shows why serialization is creating a safer and more transparent worldwide system for drug manufacturing and…
It’s an understatement to say a lot has changed in our industry in the last 10 years. Comparing the pharma and biotech landscape of 2006 to that of 2016 isn’t…
This was the headline from a DoJ Justice press release on October 14, 2015: “Two Drug Suppliers Plead Guilty in Nationwide Prescription Drug Diversion Scheme.” Before we detail the cases,…
In year 2018, we’ll look back at 2015 and reminisce about the simplicity of lot controlled manufacturing. Under today’s lot control standards, when a lot of 50,000 is produced and…
Last week, I wrote about commissioned serial numbers and questioned whether getting only commission serial numbers from the CMO is sufficient. Before I can answer that question, let us first take…
Upcoming Webinar Global Serialization 3 of 3: A Closer Look at EU Falsified Medicines Directive (Thu, Dec 3, 2015, 11 am Eastern Time) EU Falsified Medicines Directive (FMD) became effective…
When it comes to event data for serialized products, many individuals are confused about both the events and the data. Take commissioned serial numbers for example: commissioning is the event,…
The DSCSA requires wholesale distributors (WD) and third-party logistics providers (3PL) to report licensure and other information to the FDA annually. This reporting is through FDA’s CDER Direct Electronic Submissions…