April 2008 Issue
Materials characterization and the principles of manufacturability are guiding a Florida-based contract research and manufacturing company.
The concept of a process signature can easily be extended to stability testing.
Most drug companies already have access to sales data that would allow them to react more quickly to changes in demand. Are they using it?
In addition to the Design Space and the Control Space, should the People Space be added to the QbD lexicon?
A brief look at how PAT methods are being applied to better understand and characterize the pharmaceutical drying process.
Justin Neway, CSO of Aegis Analytical discusses pharmaceutical process development, QbD, and manufacturing.
Experts give some Big Pharma companies high marks for their environmental initiatives. Benchmarking efforts and new tools promise to make it easier for all drug companies, regardless of size, to improve performance and reduce costs.
While the industry waits patiently for ICH Q10 to show us the way to incorporate ICH Q8 and Q9, the basic framework already exists in FDAs Quality System Regulations for devices.
Toyota immortalized the Seven Deadly Wastes. But failing to tackle the eighth, employee involvement, will doom any Lean Six Sigma project to failure.
In the absence of FDA guidance, each company or facility must develop its own approaches to change management. Fortunately, OSHA offers a model.
The Malcolm Baldrige National Quality Award Examiner, certified specialist microbiologist and Six Sigma Green Belt recently shared his views on where the industry is heading and what it needs to improve.