A growing number of pharma CEOs are now dealing with the consequences of failing to care about workplace realities and what Toyota called the gemba, or place where truth will be found.

If the idea of reading a book on ethics or philosophy is too off-putting....after all, it has been a rough week....why not simply listen to The Clash's hit song "Should I Stay or Should I Go?" The answer's right there. "If I go there will be trouble, and if I stay it will be double."  
From 'On Pharma'

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.  They've included

From 'On Pharma'

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.

From 'On Pharma'

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.

From 'On Pharma'

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.

From 'On Pharma'

At this week’s PAT/QbD meeting, sponsored by FDA and the University of Rhode Island’s College of Pharmacy, there was no question that the speaker everyone was waiting to hear from was Ajaz Hussain, former PAT team leader, Sandoz executive and now VP at Philip Morris International.

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.

From 'On Pharma'

Overall Equipment Effectiveness is a hot topic these days and it's one area that drug manufacturers are achieving clear time and cost savings without too much effort. Setting OEE percentage targets and aiming to achieve world-class production levels can be a truly motivating exercise, as Teva's Duane Hiveley told me recently--see "Leveraging the Simplest KPI" about Hiveley's initial efforts with OEE in Irvine, California.

From 'On Pharma'

Recent postings in the WSJ blog and elsewhere have asked the troubling question: Does Lean Manufacturing, by definition, lead to quality control problems? Click here for an interesting read. (For something that doesn't require registration, click here.)

From 'On Pharma'

Mylan Labs has reportedly filed a second lawsuit against the Pittsburgh Post-Gazette, in the wake of an ongoing feud between the two over an article the paper published alleging that Mylan operators systematically ignored alarm warnings.

From 'On Pharma'

Everyone keeps talking about how the industry is on the brink of great change….it’s the death of the blockbuster….the birth of…what?  The niche-buster? Personalized medicine? 

Just keeping up and fire-fighting may be difficult enough so it is tempting to be like Scarlet O’Hara, as in “we’ll just deal with those issues tomorrow.” 

From 'On Pharma'