QbD and PAT: What’s In It for the Little Guy?
The stage seemed set for the “Brave New World” of total process understanding and control that we’ve been waiting for and talking about for years. However, I was not just chatting and communing with my...
View ArticleQbD: Enabling Process Knowledge Beyond Validation
If we, as an industry, do not take to heart that improving quality, science and process knowledge is in our patients’ and shareholder’s best interest, then we deserve the same fate as the Big Three car...
View ArticleHow Can QbD’s Progress Be Measured?
Survey data say that PAT and QbD are not gaining traction, but are there other ways to measure drug manufacturers' advances?
View ArticleIf QbD is the Map, Then PAT Is the GPS
Mettler Toledo’s Terry Redman offers an analogy that may help us all understand how PAT and QbD complement and depend upon each other.
View ArticleGet Engineers and Chemists Talking, or Face the Black Box Syndrome
Technology is advancing fast, but the communication between process engineers, chemists, biologists, and others on drug development teams is not, says Claus Weisemann, VP Quality & Regulatory...
View ArticleQbD Tools: Process Control Software with a Chemometric Engine
A look at a new software offering from Nirvention of the Netherlands.
View ArticleRethinking Time to Market
QbD “isn’t about getting to market fast,” writes J. Paul Catania. “QbD is about getting to market reliably."
View ArticleAjaz Hussain on the State of Pharmaceutical Manufacturing
The progress of Quality by Design and other key industry initiatives is slow, says Ajaz Hussain, CSO at Philip Morris International and former Deputy Director of OPS and head of the PAT Team at FDA....
View ArticleBaxter: Modeling for Real-Time Release of Device Components
Lee Hutson elaborates on how Baxter has “stolen” lessons from pharma and implemented PAT and QbD for advances in medical device manufacturing.
View ArticleQbD-Based RTR: A Systems Engineering Approach
Today, many assume that real-time release (RTR) is about testing a product quality real-time at the end of its manufacturing process and then from the result obtained deciding about lot release.
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