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...
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.
Earlier this year, Milwaukee Journal Sentinel reporters Raquel Rutledge and Rick Barrett conducted a four-month investigation into manufacturing issues at the Hartland, Wisconsin facility of H&P Industries, which (until a recent consent decree) produced hospital wipes, cough syrups, ointments, creams, and other health products.
The most popular piece of content on PharmaManufacturing.com for the past month or so has been "Pfizer Reinvents Lean in the Lab," an in-depth look at how the QA/QC labs in the company's Grange Castle, Ireland, site, have revamped and "Leaned" their work habits.
Traces of the wood preservative TBA (2,4,6-tribromoanisole) have reportedly been found in batches of the HIV medication Prezista, manufactured by Janssen Cilag, a J&J subsidiary. according to a news report in the U.K. publication, Pink Paper. So far, five batches have been recalled.
The 60 Minutes interview with GSK whistleblower Cheryl Eckard is now available online here, after airing on CBS last night. Eckard primarily discusses the mixup of drugs at the Cidra, Puerto Rico facility and her efforts to not only stop outgoing shipments but to have the plant shut down.
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).
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.
Pharma whistleblowers don't always fare too well...especially those who deal with the invisible world of manufacturing. Remember Mark Livingston and the Wyeth Sarbanes-Oxley case? However, Cheryl Eckard, who pointed out manufacturing deficiencies at GSK's Cidra, Puerto Rico, plant has received a $96-million payment. For more from The Guardian, read on.