In September, FDA sent a warning letter to Sichuan Pharmaceutical Co., an API manufacturer in China. The letter cited the manufacturer's failure to adequately guard against potential product cross-contamination:
Two of our favorite shows to cover during the fall conference season are the ISPE and AAPS annual meetings. Unfortunately, this year they came at exactly the same time. As ISPE kicked off earlier this week in San Diego, AAPS goers were flying into LA just up the coast.
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.
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...
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.
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