@Risk

Supply chain security is now a top concern for companies throughout the pharmaceutical industry. Several recent high profile cases have underscored vulnerabilities, and most pharma organizations now recognize that a holistic approach is required to detect and prevent adulteration, counterfeiting, illegal diversion, and theft.

Last month, ISPE, a global not-for-profit association of 22,000 pharmaceutical science and manufacturing professionals, released a white paper to help firms address these critical supply chain issues. “Supply Chain Security: A Comprehensive and Practical Approach” encourages pharmaceutical companies to strengthen their overall supply chain security by adopting a layered approach that includes:

• Signal detection and response

• Supplier quality management

• Management of logistics and transportation services providers

• Additional specific programs

I found the discussion of signal detection and response particularly interesting, as it illustrates how adulteration of one particular excipient can have broad effects on the quality of finished products across several countries and can impact several organizations. Here’s an example from the report: (more…)

The counterfeiting of pharmaceuticals is growing in both scope and impact, and now manufacturers and regulators alike are searching for more sophisticated traceability systems.

One “breakthrough approach” currently in development will allow manufacturers to label their products with a two-dimensional dot-matrix that is linked to an online database. GB Innomech, the company developing the new coding system, says this new approach is low-cost and effective: (more…)

Counterfeiters continue to infiltrate the global pharmaceutical supply chain, and increasingly now thay appear to be targeting high-value drugs, such as HIV antivirals and cancer treatments, according to FiercePharmaManufacturing.

In fact, in Germany, dozens of pharmacies are currently under investigation for suspected distribution of illegal and fake drugs, including painkillers, antibiotics and cancer treatments, as well as so-called “lifestyle medicines,” such as impotency drugs and bodybuilding products. This high-profile case seems especially troubling because, among other things, the pharmacists are alleged to have mixed illegally-acquired medicines with genuine product. (more…)

Based on the large amount of traffic at my last post –“How Many Fake Parts Are In Your Supply Chain?” –it’s clear that many of you are thinking about the integrity of your supplier networks.

But, remember this: That integrity isn’t dependent solely on genuine electronics and the other components that we typically think of as “parts.” The integrity of your supply chain also relies on that ambiguous, amorphous factor known as the “human element.”

And in fact, it seems that these days the human element matters more than ever before.

Thomas Friedman eloquently discusses this very issue in his Op-Ed piece, “A Question From Lydia,” in yesterday’s New York Times.

As Friedman sees it, our increasingly integrated world has made us –and by extension, our supply chains –more ethically interdependent.  He writes: (more…)

In yesterday’s post about the FDA’s new PREDICT program, I included a few startling statistics about pharmaceuticals imports.

Today, new survey results suggest that global life science companies are increasingly concerned about growing global supply chain complexity and its effect on quality and compliance.

The survey, conducted by Sparta Systems, was administered to professionals in the pharmaceutical, biotech, medical device and blood/tissue industries. The data reveals that: (more…)