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...
Call for QbD Consultants!
About once a month, I receive a QbD consulting request. Unfortunately, I declined them due my limited availability. One thing I did was – connect companies with a few consultants that I knew. I’d like to do this more by opening up the directory to those who need to seek QbD consultants. Are you...
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...
What Matters to Patients? QTPP for Vaccines: A-Vax Case Study
Many of you asked for the QbD Risk Assessment Template for Vaccines. We are happy to announce that it is now available. CMC-Vaccines Working Group published a QbD case study: A-VAX: Applying Quality by Design to Vaccines in 2012. The QTPP-CQA-CPP/CMA template is based on this A-Vax case study....
QbD for Pre-filled Syringes and Injection Devices
This week, I’m at the 2014 PDA Universe of Prefilled Syringes and Injection Devices and 2014 PDA Drug Delivery Combination Products Workshop. Only two talks have “QbD” in their titles. The good news is that QbD jargons and practices are beginning to show up in other sessions. Earlier...
What Experts Do: RPN for QbD Risk Assessment
Previously, we learned: To use a RPN scale commensurate at the level of information available. If you are in development stage, High-Med-Low is recommended. When discussing Control Strategy, separate the rankings of Severity and Occurrence. At the development stage, the main goal of Risk Assessment in Quality by Design...
Inconvenient Truth: RPN in QbD Risk Assessment
You heard the story about the troubled QbD Risk Assessment meeting. Picture yourself and 4 scientists starting a meeting in a conference room at 4pm. Scenario: Fighting over a rating of 3 versus 4 Project Lead: Let’s continue our Risk Assessment using FMEA. Today we’ll assess the severity of Quality Attributes to...
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...
Why Not Use Design of Experiments for QbD?
Confession Today, I share an embarrassing story… I did not truly appreciate DOE. When I was teaching Six Sigma topics at Stanford University and Keio University, I only scratched the surface level. Main reason was that most project sponsors could not share their proprietary or confidential details (process parameters), hiding real numbers...