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 this website is to take out the fluff and get to the core essence of QbD — and share it with others along the way. As a QbD practitioner myself, I personally strive to push beyond theory and seek results.
This page contains the information you need to get up to speed quickly and start your organization’s QbD initiative.
Feel free to read top-to-bottom or jump around the articles.
What is Quality by Design?
Let’s first cover the basics. “Quality-by-Design is 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.” (Ref: ICH Q8 R2, 2009)
This sounds all great but where do I start? If you are planning on launching a QbD program, I strongly recommend securing an executive sponsor to support your initiative. Otherwise, prepare for a steep uphill battle.
So…How do I Justify QbD to my Executives?
This is a tough one. There are no silver bullets but here are some business justification articles that you can reference.
Building a Business Case for Biopharmaceutical QbD Implementation (2012, Junker, BioPharma International)
Now that you have the “License to Implement QbD,” what’s the next step?
How to Implement QbD?
In essence, QbD is successfully connecting the 3 core elements — 1. Risk Assessment – 2. Design Space – 3. Control Strategy — in order to understand the link of QTPP – CQA – CPP and control them.
Risk Assessment is the tool to determine the link of QTPP – CQA – CPP. This is the first step and therefore a critical one.
DOE – Design of Experiments is the common approach to characterize Design Space.
Are there any examples or case studies? Yes!
QbD Case Studies
Large Molecules, Biologics case studies
Perjeta-Lessons from Failure and Success
Small Molecules, Generics case studies:
Design Space Considerations (FDA, 2012)
Medical Devices (Combination Products)
Labeling for Biosimilar Products (FDA, 2016)
CELLTRION Infliximab Biosimilar (FDA, 2016)
Submission Tips from CMC and Regulatory Agency Reviewers
CMC Considerations for a Successful Regulatory Submission (Madurawe, FDA)
ICH Q8, Q9, Q10 Questions and Answers – R4 (FDA, 2011)
ICH Q8, Q9, Q10 Q&A (FDA, 2012)
FDA Applying ICH Q8(R2), Q9, and Q10 (FDA, 2016)
Good ANDA Submission Practices (FDA, 2018)
MAPP-Good ANDA Assessment Practices (FDA, 2018)
I will continue to add to this page. Please contact me if you have any suggestions!