Category: 483's Quality Accountability J&j 10 Worst Drug Recalls In Fda History Compounding Facilities Cgmp Compounding Problems
Submitted by pharmamanufacturing on Wed, 12/12/2012 - 11:32
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...
Submitted by pharmamanufacturing on Wed, 02/08/2012 - 20:47
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.
Submitted by pharmamanufacturing on Wed, 02/08/2012 - 19:59
Category: Pharmaceutical industry management Pharmaceutical researchers Process Analytical Technologies The Pharma Industry Pfizer Pharma Workforce and Staffing Pharmaceutical Mergers and Acquisitions Pharmaceutical Industry CEOs Quality Accountability Pharmaceutical Industry Reputation Pfizer Sandwich Pfizer Wyeth Pharma Ceo's Wy-pfi Merger
Submitted by pharmamanufacturing on Thu, 02/03/2011 - 09:38
Category: Pharmaceutical industry management management FDA cGxP's FDA and Regulatory Issues The Pharma Industry Peter Rost Pfizer Whistleblowers Pharmaceutical Industry Conflicts of Interest Pharma Workforce and Staffing 483's Ethics Quality Accountability Taxpayers Against Fraud (taf) Michael Gregor Nolan And Auerbach Dodd-frank John Fleder Robert Riordon Leslie Wood
Submitted by pharmamanufacturing on Wed, 11/17/2010 - 13:47
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).
Category: Pharmaceutical industry management cGxP's FDA and Regulatory Issues The Pharma Industry Pharmaceutical Industry CEOs Quality Accountability
Submitted by pharmamanufacturing on Thu, 11/11/2010 - 11:49
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.
Category: FDA cGxP's FDA and Regulatory Issues Lean Six Sigma and Quality Improvement The Pharma Industry Pharma Workforce and Staffing Pharmaceutical Industry CEOs J&J Toyota 483's Tunnell Consulting Operational Excellence Quality Operator Error CDER OEE Ajaz Hussain Park Doctrine Accountability Misdemeanor Charges For Pharma Ceos Ray Scherzer Ken Leiper
Submitted by pharmamanufacturing on Tue, 08/31/2010 - 11:31
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.