QbD Risk Assessment Without Many Meetings (Recipe Part 1)
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...
Design Space in QbD — Definitions
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)...
QbD: Past, Present and Future by Anurag Rathore
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....
QbD Framework – in 2 Minutes (for Scientists)
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...
Ask Questions: Upcoming Interview with Anurag Rathore
Submit your burning QbD or PAT questions! This week, I am thrilled to interview Dr. Anurag Rathore, the co-author of Quality by Design for Biopharmaceuticals: Principles and Case Studies. We’ll talk about Anurag’s personal journey and his book in QbD. Dr. Anurag S. Rathore is currently a professor at...
3 Reasons Why QbD Risk Assessment is Key + 3 Tips
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...
QbD Risk Assessment 2.0 — Coming Soon!
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...
Sample Size Question – How to Answer it as a R&D Scientist
How to answer the question–“What Sample Size do we need?”– as a R&D scientist. Before running an experiment, you or someone from Quality will inevitably ask the sample size question. You could regurgitate this or use this calculator. However it’s still confusing. Here’s how to answer it in...
1st QbD Approval for Biologics: Gazyva Design Space
“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...
FDA Reviewer Reveals Tips on QbR for Drug Substance
Are you in the Generics industry? Then you should be familiar with QbR for Drug Substance. Barbara Scott of OGD (Office of Generic Drugs) at FDA shares insider’s tips on how to successfully file a Question based Review submission. She breaks down the questions regarding Drug Substance in Sections...