June 6th 2025
ICH Q6B provides expectations and a clear framework for the structural characterization of biopharmaceutical products.
Quality Is in the Eye of the Inspection System
November 12th 2008Until recently, automated inspection of solid-dose pharmaceuticals was crude, expensive, slow, and difficult to change over. But technological advances have ushered in a new class of vision-inspection systems that is more effective and more commercially viable than older systems.
Risk Management within the Global Supply Chain
October 1st 2008The growth and globalization of the pharmaceutical supply chain make risk assessment more important than ever for pharmaceutical manufacturers. The authors describe a program to identify, prioritize, mitigate, and communicate risks in manufacturer–supplier relationships.