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 - 19:59
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: 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.
Category: Pharmaceutical industry management Process Analytical Technologies FDA cGxP's FDA and Regulatory Issues The Pharma Industry Ranbaxy 483's Quality
Submitted by pharmamanufacturing on Fri, 02/05/2010 - 10:54
FDA has been advocating process knowledge and understanding for a long time now. The Agency's statements always generate "hear, hear's" and motherhood-and-apple-pie type assents and approvals among industry types...."Of course, we need to understand our processes."
Category: AstraZeneca Amgen Abbott Laboratories Eli Lilly Pharmaceutical Industry Goodwill and Philanthropy 483's Haiti
Submitted by pharmamanufacturing on Thu, 01/14/2010 - 12:13
The drug industry is usually out front in assisting disaster relief, and many manufacturers have already come forth with major donations of money and supplies to Haiti in the aftermath of this week's earthquake.
Category: cGxP's FDA and Regulatory Issues The Pharma Industry India China and Asian Pharma Supply Chain Management heparin Supply Chain Security Anticounterfeiting 483's
Submitted by pharmamanufacturing on Mon, 04/20/2009 - 16:17
Some of those in favor of relaxed reimportation often argue that the drug industry is fear mongering when it points to potential safety problems with drugs or ingredients sourced from abroad. "Be afraid, be very afraid.