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 Lean Six Sigma and Quality Improvement The Pharma Industry Pfizer Vaccines Pharma Workforce and Staffing Pharmaceutical Mergers and Acquisitions Pharmaceutical Industry Videos Wyeth management Apotex Lean Manufacturing Operational Excellence Quality OEE
Submitted by pharmamanufacturing on Tue, 05/18/2010 - 17:59
Did any of you catch that recent WSJ report on the negative impact of mass layoffs? OK, I know that M&A layoffs are different, but today brought the sad news that Pfizer/Wyeth will lay off 6,000 employees and close eight of its manufacturing plants in Ireland, Puerto Rico and the U.S.
Category: Process Analytical Technologies cGxP's FDA and Regulatory Issues Pharmaceutical Process Analytical Technologies The Pharma Industry QbD Process Validation Quality By Design Operational Excellence Quality PAT CDER Keith Webber
Submitted by pharmamanufacturing on Fri, 05/14/2010 - 09:14
At this week's FDA meeting on PAT and QbD, someone in the audience asked CDER Deputy Director Keith Webber, who had spoken about PAT, QbD, process validation (old vs. new) and real time release vs. end of line testing, whether FDA would ever require PAT.
Category: Process Analytical Technologies FDA Pharmaceutical Process Analytical Technologies The Pharma Industry Biotechnology and biopharmaceuticals QbD Quality By Design Operational Excellence Quality CDER Ajaz Hussain Philip Morris International
Submitted by pharmamanufacturing on Thu, 05/13/2010 - 10:30
He burst energetically up to the podium, briefly recapping the history of why PAT was advanced. At the time, he said, FDA was resisting ICH Q8, although Europe and Japan were embracing it.
Category: Pharmaceutical Process Analytical Technologies The Pharma Industry Gawayne Mahboubian-Jones QbD Ali Afnan R&d Quality By Design Quality Ajaz Hussain Philip Morris International Optimal Industrial Automation Syntq
Submitted by pharmamanufacturing on Thu, 05/13/2010 - 08:49
Last week, Gawayne Mahboubian-Jones, one of the key thought leaders of the pharmaceutical PAT movement, left a position at Optimal Industrial Automation, whose SynTQ software is finding more users in life sciences, to join Philip Morris International as Program Manager, Excellence in Science and Design.
Submitted by pharmamanufacturing on Mon, 04/05/2010 - 09:06
The saga of KV Pharmaceutical provides a cautionary tale for any manufacturer who would overlook manufacturing quality issues and attempt to fly under the regulatory radar. As most in the industry know, KV has gone from a model growth company to one on the brink of bankruptcy, following manufacturing issues...
Submitted by pharmamanufacturing on Wed, 03/24/2010 - 14:26
Genzyme is likely to enter into a Consent Decree with FDA over ongoing cGMP problems at its Allston facility. The company says that FDA plans enforcement action. Here, reporting from Wall Street Journal today. Blogger Jim Edwards notes a 14-year history of compliance issues at Genzyme on his blog today.
Category: Process Analytical Technologies FDA cGxP's FDA and Regulatory Issues Lean Six Sigma and Quality Improvement Pharmaceutical Process Analytical Technologies The Pharma Industry QbD Ali Afnan Quality By Design Quality PAT Desired State Manuel Hormaza Interphex Puerto Rico
This week, the FDA will lose its most eloquent advocate for process analytical technologies (PAT): Ali Afnan, senior staff fellow at CDER's OPS. who leaves the Agency this Friday to pursue a career in independent consulting.
Submitted by pharmamanufacturing on Wed, 02/17/2010 - 18:41
From the Wharton business school, an interesting piece on an easy way to motivate employees...connect them to those who benefit from their work. Professor Adam Grant has tested this theory and found it works....I'm betting that plant accidents or quality problems wouldn't happen as frequently if employees had regular contact,...
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."