September 2010 Issue
Paul McKenzie, global head of pharmaceutical development and manufacturing sciences for J&J pharmaceutical research and development, shares goals for J&J's pharmaceutical R&D, and the "Lab to Patient" program.
Interpreting results of Pharmaceutical Manufacturings fifth annual process control and automation survey.
If senior management is held directly accountable for cGMP problems, could we see a very different approach to manufacturing?
If Ashton Kutcher were in pharma, hed be on LinkedIn.
Our foundations for Quality by Design are of poor quality, yet industry and FDA continue to let things slide.
A look at what microbiologists do and want, by the numbers, and commentary from consultant Pascal Yvon.
Ask not what FDA will say about our products and processes, says Contributing Editor Ali Afnan, but rather what we can demonstrate to the Agency. Change depends on it.
The question is not whether Quality by Design is ready to help you solve the perennial challenges of drug development and manufacturing, but whether you are ready for it. Tunnell's Bill Schmidt pinpoints what exactly makes some drug manufacturers "ready" for QbD, and others not.
How to establish clear guidelines, and stay out of trouble, courtesy of compliance consultants, a finished goods manufacturer, and a supplier.
While the Agency has not established formal guidelines for manufacturers' social media activity, Roche's own attempt serves as a model.