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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)

What does this mean to a scientist (click for a 2-min Video of QbD Framework)? 

Confused about QbD jargons (click for QbD Glossary)?

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.

Selling QbD to Executive

How do I measure the progress of QbD? – KPI or metric to continue to justify QbD program (click)

Why quality-by-design should be on the executive team’s agenda (2009, Ted Fuhr, Michele Holcomb, Paul Ruttenb_McKinsey&Co.)

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

A-Mab: QbD for Monoclonal Antibody Case Study (2009, CMC Antibody WG, PDA)

Gazyva – the First QbD Design Space Approval from  Biologics

Perjeta-Lessons from Failure and Success

A-VAX: QbD in Vaccines (2012, CMC Vaccines WG, PDA)

Small Molecules, Generics case studies:

Quality by Design for ANDAs: An Example for Immediate-Release Dosage Forms

Quality by Design for ANDAs: An Example for Modified Release Dosage Forms

Question-Based Review for CMC Evaluations of ANDAsQbD for

Pharmaceutical Development  Case Study: “ACE Tablets” (2009, CMC-IM WG, PDA)

QbD in Generics (courtesy: Inna Ben-Anat of Teva, IFPAC 2013)

Quality by Design for Orally Inhaled Drug Products (Lawrence X. Yu, FDA)

QbD Approaches for Orally Inhaled and Nasal Drug Products (OINDPs) (Peri, FDA)

Analytical Methods

QbD Considerations for Analytical Methods – FDA Perspective (Sharmista Chatterjee, PhD of FDA)


Adaptation of the quality by design concept in early pharmaceutical development of an intranasal nanosized formulation (Pallagi, 2015)

Medical Devices  (Combination)

QbD for Devices – Drug Eluting Stents(Mcdermott & Chatterjee of FDA)


Submission Tips from CMC and Regulatory Agency Reviewers

Regulatory Assessment of Applicatons Containing QbD Elements – Reviewer Experience (Miksinski, 2014)

Regulatory Assessment of QbD Elements in NDA Submissions – Experience and Considerations (Miksinski, 2014)

CMC Considerations for a Successful Regulatory Submission (Madurawe, FDA)



Recommended Books



Lean QbD:  The only Risk Assessment Tool designed for QbD. 


I will continue to add to this page. Please contact me if you have any suggestions!


Related Topics:

EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use

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