On Pharma

Long Live the Revolution! Goodbye and May 2013 Be Filled With Positive Change for All of You

I apologize if some of my columns over the years have seemed a bit negative or critical.  As a publication, we started up at a time when thought leaders pointed out the seemingly limitless potential to improve and modernize manufacturing.  

Building a Culture of Quality and Compliance: Are 483's Just Part of Doing Business?

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...

Criticizing the Cynicism Behind the Current Compounding Scandal

We wanted to criticize, in as forceful and graphic a way as possible, the cynical attitude of the compounding facility management, to call attention to the disgraceful conditions that were found at many of the compounding facilities that were inspected, and also to draw some attention to the political situation (e.g.

Changes to Come at CDER: A Letter From Janet Woodcock

Just received confirmation of last post.  Here's the official letter announcing changes from CDER Director, Dr. Janet Woodcock

FDA to Give Generics More Prominence: Rumors of Change

Haven't confirmed any of this yet, but just heard rumors of change, and another 'superoffice' restructuring at FDA. Apparently, within the new framework, the Office of Generic Drugs will become a "superoffice", OPS will be no more, while OMPQ, ONDQA and OBP will report to OPQ.  The Office of Compliance...

Harmonizing QMS to Extend to Contract Manufacturers and Suppliers:

Four Reasons Why You Should Do it, Three Reasons Why You're Not

Pondering the Root Cause for, and Solutions to, Today's Drug Shortage Problem at BIO 2012

On Monday, June 18th, BIO 2012 was much more subdued than I’d remembered seeing it in the past.  However, it was just the first official day, and a number of breakout sessions touched on important topics. 

MedImmune's Skibo asks: Is Pharma Cost Cutting Sacrificing Quality?

At the ISPE/FDA conference on cGMP’s in Baltimore last week, Andrew Skibo, EVP of operations and manufacturing at MedImmune, spoke on the topic of “High Quality in a Lean Manufacturing World.”  The pharmaceutical industry’s increasing focus on reducing manufacturing costs, he said, has come at a time when the industry...

Sustainability: Pharma Reaches Above the Low-Hanging Fruit

Those who cover green and sustainability issues know that Pharma is pretty progressive. No, the industry's not perfect, certainly, but many of its leading companies also make it a point to be leaders in environmental stewardship.