Paul D’Eramo—former ISPE chair, a two-decade veteran of FDA, and current head of Quality and Compliance Worldwide for Johnson & Johnson—always has a finger on the pulse of the regulatory environment, and knows that GMPs are fluid, not static. “We are always searching for what the ‘c’ in cGMP is,” he says.

At October’s ISPE 2008 show in Boca Raton, Florida, D’Eramo offered his take on current trends that are shaping GMPs. Though not surprising, his are the words of experience and insight:

The Competing Globally track also featured a presentation on Quality by Design, made by Russ Somma, President, SommaTech LLC, who worked for several years at Novartis and is also an editorial advisor on PharmaQbD.com.  Mr. Somma joked that the industry never had quality by accident, "We don't just lumber along and wait to fall apart, but the question is: Did you ask the right questions at the right time?" There's a need to better define process needs and required capacity early on.

On Monday afternoon, a manufacturing and operations discussion group focused on the topic of global competition.  Session chair Julian Wilkins, Vice President of PharmaConsult US, Inc. and a part-time professor of Pharmaceutical Manufacturing at Stevens Institute set the stage with an introduction spelling out the issues and challenges.

A number of speakers at ISPE's conference referred to the Certified Pharmaceutical Industry Professional (CPIP) program that the organization has rolled out, providing certification that an industry professional has met a certain agreed-upon level of competence in GMPs and other critical subject areas.

Janet Woodcock, head of FDA’s CDER, strikes me as the type of person you’d want in charge during a crisis.  And that’s exactly where FDA, and CDER, have found themselves this year, so I’m not surprised that Dr. W. was reassigned from her post of Chief Medical Officer and Deputy Commissioner to head up CDER.  Using the triage imagery of the Emergency Room, running the Critical Path initiative is important, but maintaining control of CDER, drug review and inspections, is urgent.

End Pharma Parochialism: Think Globally, Act Globally

I’m typing these notes, wedged sideways so that my laptop will fit on an empty middle seat, as I fly home from ISPE’s annual meeting.  (A friendly warning:  if you are over 5’4” tall, don’t travel on Spirit Airlines unless

a. you absolutely have to, or