Category: Quality by Design

I reveal 2 secret practices today – 2 practices that will set your QbD initiative up for success. I call them secrets because they are the most uncommon QbD practices – especially in the United States, where I work and reside. As facilitators of QbD risk assessment meetings, not...

Thanks to you, your company just saved $56,400 in variable cost and $15 Million in opportunity cost. This comes from eliminating 9 unnecessary group meetings, 12 hours of individual work and a minimum of 3 weeks of delay time to market launch. In Steps 1 and 2, we assessed...

If you’ve experienced Risk Assessment sessions, you will be familiar with how much time is spent at the beginning — just trying to collect the QTPP, CQA and CPP’s. The good news is that most products (biologics and small molecules) share similar manufacturing processes. Accordingly, they share similar sets...

If you are new to QbD, here are the basic definitions of “Design Space” in QbD. If you have to explain the terminologies to your colleagues, you can refer them to this page as a resource. I’m building a resource page (Start Here) for QbD newcomers. ICH Q8 (R2)...

I am thrilled to have Dr. Anurag Rathore share his QbD journey with our QbDWorks community. This is a followup to the previous post. This is a part of QbDWorks interview series where we interview the thought leaders of Quality by Design to discuss what works and what doesn’t in QbD....

When I began my QbD journey, I was confused by the jargons that FDA or ICH used (or created) in their guidelines. After some time I understood it. But now I had to explain it to those who are new to Quality by Design. They were unimpressed due to...

Have you led or supported a QbD project? Then you will agree that Risk Assessment is a critical piece — like the small hinge that a big door (QbD) revolves around. The activity may seem trivial but has major implications.  In fact, QbD revolves around risk assessment. If you...

After stirring up a discussion on QbD Risk Assessment, I went quiet. Here’s why. Background: QbD at Risk I couldn’t sit through another Risk Assessment meeting. I was tired of long meetings and “most attributes are high-risk” results. The worst part — scientists did not support the process. This...

  “This will be the first OBP BLA* with an approved design space.” (CDER, *OBP: Office of Biotechology Products, BLA: Biologics License Applications). Quality-by-Design in Biologics is challenging. Skepticism prevails. (i.e. Matej Horvat’s excellent discussion). I outlined a few reasons why QbD in Biologics is challenging in an earlier article. Complexity and heterogeneity...