QbD Case Study – ACE Tablets – QTPP, CQA, CPP, CMA
If you are in the generics industry, you should know about the QbD case study on ACE Tablets. CMC-IM working group published a QbD case study on Acetriptan or “ACE Tablets” in 2008. This article covers: Typical Approach of QbD Case Studies Process Map of ACE Tablet Manufacturing...
How to Describe QbD — in 1 Sentence — over a Holiday Dinner
A question always comes up during holiday dinners – “What do you do again?” I begin sweating. Hmm…I have to think for a minute before I respond. Then it goes something like this: Me: “Well, you know that drugs you take are manufactured in big facilities but are designed by...
Uncertainty vs Occurrence in QbD Risk Assessment
While extracting QTPP, CQA and CPP’s from the A-Vax case study, I noticed some authors used “uncertainty” instead of the popular “occurrence” for their QbD Risk Assessment. What this means is that the Risk Priority Number (RPN) equation: RPN = Severity x Occurrence becomes RPN = Severity x...
QbD for Vaccines: A-Vax Control Strategy [Slides]
If you are applying QbD for Vaccines, this presentation will be helpful. Dr. Hyun Sung Kim presented a summary of A-VAX case study at KOBIA 2014. Dr. HS Kim (HS from hereon) is the Quality Director at Green Cross, Korea. I share my notes with you. As with any...
Current Status of QbD in Korea (2014)
I just spoke at KOBIA’s 2014 QbD Workshop. Thanks to my dear friend, Prof. Yoon at Univ. of Mass at Amherst, (who also invited me to BPQC 2014). The QbD workshop had a good turnout of 120 representatives from Korean Biopharmaceutical companies. The sessions included 4 sessions, ending with...
JMP Setup Guide for DOE – in 1 Minute
Now that we’ve covered: How to conduct QbD Risk Assessment in a smart way, I’d like to move onto the next step – QbD Design Space in a smart way. Before we get into details, let’s set up our main tool –JMP– for success. Surprisingly, many JMP users aren’t aware...
QbD Risk Assessment – Without Many Meetings (Part 2)
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...
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...
Start Here
If you’re new to Quality by Design (QbD) or Process Analytical Technology (PAT) — Welcome to QbDWorks! I’m Sun Kim, PhD — the Experimenter of Quality by Design (QbD) — testing and sharing what works (and what doesn’t). There’s hype in any initiative . QbD is no exception. My goal for...
QbD Definitions
QbD Definitions Quality-by-Design (QbD): a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management Quality Target Product Profile (QTPP): a prospective summary of the quality characteristics of a drug product that ideally...