Pop quiz!  Where did the following snippets from FDA citations come from? (Winner gets a free coffee mug, runner up gets two -:))

• Contamination during the manufacture of serum injectables?
• Failure to measure or account for endotoxins?  
• Failure to respond to adverse patient reactions?  
• Presence of vermin and unsanitary conditions at the facility?

A survey that came out late last year attempted to put an actual figure on the cost of pharma quality problems.  Should make it easier for some of you to get funding for those QbD/PAT/process control projects. We hope. For more, read on.

AMS

ostrich

The ostrich has become a staple of many pharmaceutical science presentations of late, symbolizing an industry that is reluctant to change. Perhaps it could symbolize some of the more shortsighted pharma CEO's at this point in the 21st century. With all due respect, as CEOs face a tough balancing act today, I have a few questions for this elite group:

Most of the U.S. Department of Justice’s major pharma-related decisions invoking the False Claims Act recently have involved illegal marketing and sales. So far, GSK’s is the only one to deal with current good manufacturing practices (cGMP’s).  Read on for a roundup of the top 20 recent cases from Taxpayers Against Fraud (TAF).

Uberblogger Pharmagossip and the expert satirist Pharmagiles recently posted riffs inspired by the GSK whistleblower case, with Pharmagiles setting the lyrics to Harry Belafonte's famous Banana Boat Song. Click here for a view.

Just read Mina Kimes' enlightening account of the J&J McNeil quality disaster in Fortune. Forget about the fact that the adulterated products did not and most likely would not have harmed consumers, the problems cited are very serious and go straight to the heart of GMP's.