FeedIssue Archive
April 2008
Articles
Therapeutic Dose: Extending QbD to Stability Testing
The concept of a process signature can easily be extended to stability testing.
Focusing on Phase 0
Materials characterization and the principles of manufacturability are guiding a Florida-based contract research and manufacturing company.
Swimming the Channel
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?
From the Editor: QbD and the People Space
In addition to the Design Space and the Control Space, should the “People Space” be added to the QbD lexicon?
Drying Requires Functional Model
A brief look at how PAT methods are being applied to better understand and characterize the pharmaceutical drying process.
Process Development and Manufacturing Need To Be One Team
Justin Neway, CSO of Aegis Analytical discusses pharmaceutical process development, QbD, and manufacturing.
The Greening of Pharma
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.
Drug Delivery and QbD: A Collision of Lifecycles
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 FDA’s Quality System Regulations for devices.
Eliminate the Eighth Waste
Toyota immortalized the Seven Deadly Wastes. But failing to tackle the eighth, employee involvement, will doom any Lean Six Sigma project to failure.
Management of Change: Every Plant for Itself!
In the absence of FDA guidance, each company or facility must develop its own approaches to change management. Fortunately, OSHA offers a model.
Minimizing Error
Human error can occur at any stage in the drug manufacturing process. Machine vision systems will never replace operators but they can empower them to reduce errors and improve efficiency.