May 2008 Issue
ICH Q-10 marries the best of cGMPs and ISO 9001:2000 but a clear vision of process-based management systems is needed.
A good working relationship is critical to the success of any vendor quality agreement, but the right approach to drafting these contracts can make them far more effective.
April brought painful reminders of the human cost of pharmaceutical quality control problems, the need for more FDA resources and better supplier risk management. It also highlighted the tenuous relationship that the Agency and its leaders already have with many U.S. lawmakers.
Sensors are being developed that will advance process control in biopharmaceutical manufacturing. This article takes a look at the anticipated changes in bioprocess control in the upcoming years.
As it develops its quality systems and risk management strategies, pharma can learn a lot from military aviation
Like open-pit mining, too great a focus on reduced labor costs leaves toxic tailings.
The fermentation process is already fraught with risk. Monitoring offers an early warning system that can ensure batch-to-batch consistency and minimize waste.
A brief look at biopharmaceutical manufacturing, then and now, through the lens of Quality by Design.
A look at how the technology works and how is was applied to study antimalarial tablets.
The deadly business of drug counterfeiting is growing, but so are the options available to prevent and fight it.