Archive for the ‘Drug Manufacturing’ Category

Off-label uses… the Windex of the medical field?

You’ve heard the term, “cure-all”, I’m sure, but as we all know, there is no real “cure-all” in life. If you ever watched the movie, “My Big Fat Greek Wedding”, then you are all too familiar with the father of the bride who believes that Windex is the “cure-all” for everything. As he states in the movie, “from psoriasis to poison ivy, put some Windex on it!” Windex, however is not a magic potion. It is simply intended for cleaning windows, mirrors, glass shower doors, glass top stoves and more as stated on their website. In fact, Windex in high concentrations can be very caustic, because it contains ammonia! Maybe the father of the bride should have done some research before promoting Windex’s unapproved uses!

In the medical field, doctors, like the father of the bride in the movie, use many products for unapproved uses. In our industry, the Food and Drug Administration (FDA) requires that medical devices, drugs, biologics and combination products be used according to its labeling of approved (or “on- label”) uses. Oftentimes, however, doctors end up using products for “off-label” use. With this FDA requirement, how is it that doctors are able to use these products for unapproved uses? Read more »

Why is the FDA still finding basic nonconformities in manufacturing?

Every so often, I take the time to catch up on the FDA’s findings that result from the latest audits of drug, device, biologics and combination product manufacturers. It always astonishes me as to how these nonconformities occur, namely because the findings seem like simple issues that can be easily avoided. Throughout my career, I have seen various incidents like these occur, such as while walking through the manufacturing areas on the way to my workstation, conducting internal audits, performing supplier audits, or being audited by the FDA.

It occurred to me while I was reviewing these findings that if I think these issues are a simple fix, my guess is others will too, and by bringing awareness to these issues maybe it can prevent some headaches for the next company to be audited. If you’re looking for some insight into what the FDA is still finding, these are just a few of the findings that I came across. Read more »

Reduce Operating Costs and Improve Service with a Large-Scale Supply Chain Transformation

For your pharmaceutical company, reducing operating costs and improving service are possible with a large-scale supply chain transformation. While this kind of extensive reworking of your supply chain may seem intimidating and unnecessary, it can help make your company’s costs smaller, its reach greater, and its manufacturing needs more streamlined which will, in turn, positively affect your company as a whole. Read more »

What is Driving the Drug Recall Surge?

The recent drug recall surge from the FDA has been somewhat staggering. According to RAPS, “2014 is already shaping up to be the biggest year for serious drug recalls in the last decade.” The total number of drug recalls so far almost surpasses that of 2013, which in itself was extremely high. With the year not over yet, 2013 and 2014 could see more recalls than the previous nine years combined.  Read more »