ICH Q12 Examples – Pharmaceutical Product Lifecycle Management Examples – FDA Guidance
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QbD Application in Pharmaceutical Development for Nano Formulation
“This method (in QbD) can improve pharmaceutical nano-developments by achieving shorter development time, lower cost, saving human resource efforts and more effective target-orientation.” Edina Pallagi, PhD, Rita Ambrus, Piroska Szabó-Révész, and Ildikó Csóka (University of Szeged) recently published, “Adaptation of the quality by design concept in early pharmaceutical development of...
3 Tips from FDA and EMA on QbD Risk Assessment for Regulatory Submissions
Every day, I receive more than 25 emails just on Quality by Design. I’ll share these questions and answers in the future, but today, we cover the questions received by FDA and EMA. FDA and EMA share 3 tips on QbD Risk Assessment and Design Space for Regulatory Submissions....
How to Choose Which Design Space Studies to Work On – Why QbD Risk Assessment is Not Just a Risk Assessment
If you ask an average pharmaceutical scientist, “What is QbD?” she or he will mostly likely answer: DOE (Design of Experiments). As scientists, we are attracted to design space studies (including myself) because it is an extension of our daily work. However the bigger question is – “Which process...
FDA on Prefilled Syringes and Combination Products — What This Means for You
This regulation affects all of us. Most of us focus only on one of these: Drugs, Therapies, or Devices. However unexpected failures and mistakes happen more often at the interface of the three, shares Dr. Lana Shiu of CDRH at FDA. I met Dr. Lana Shiu after her presentation at...
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...
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....
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...
2 Uncommon QbD Practices — Why You Should Pay Attention
I reveal 2 secret practices today – 2 practices that will set your QbD initiative up for success. I call them secrets because they are the most uncommon QbD practices – especially in the United States, where I work and reside. As facilitators of QbD risk assessment meetings, not...