ICH Q12 Examples – Pharmaceutical Product Lifecycle Management Examples – FDA Guidance
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QbD for Dry Powder Inhalation Formulation (Combination Product)
Dr. Edina Pallagi is the QbD pioneer of Hungary. The University of Szeged team recently published, “New aspects of developing a dry powder inhalation formulation applying the quality-by-design approach” For a complimentary PDF access, download the QbD case study by Sept. 5 The one-sentence takeaway is: By...
QbD – Doing More with Less with these 3 Tools [Mehtap Saydam]
What if we could predict the relationship of QTPP, CQA and CPP of our drug – with less clinical data? Mehtap Saydam, our QbD evangelist from Turkey describes that there is a way with the 3 tools – In Vitro Testing; Biopharmaceutical Classification Systems; and QbD Risk Assessment. “In...
QbD Workshop at Biomanufacturing Summit, May 23-24, 2016 at UMass Lowell
For those implementing QbD in biologics, join us in May at University of Massachusetts. Agenda and registration are as follows: QbD Risk Assessment & Design Space Workshop: May 18-20 2016: Wednesday – Thursday, 8:00AM – 5:00PM; Friday 8:00AM – 12:00PM Biomanufacturing Summit, May 23-24, 2016 at UMass Lowell...
QbD Implementation on Medical Devices (Drug Eluting Stents)
Does Quality by Design apply to Medical Devices? We’ve seen it coming down to combination products. Now QbD implementation on Medical Devices. My colleagues working in the medical devices claims Design Controls is comparable to QbD. Design controls is a FDA guidance to product development activities. However, it is...
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...
How to integrate Raw Material Variation into QbD Risk Assessment
It’s Not the Development Scientists’ Fault! As an R&D scientist, I experienced the pressure of tight development timelines. I wanted my verification, qualification or validation lots to pass the first time so we can meet our milestones (= and to get a positive annual performance review). To achieve this, I...
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 Implement QbD in Generics – Interview with Inna Ben-Anat
Meet Inna Ben-Anat, Global QbD Director of Teva Pharmaceuticals. Inna is a key thought leader in Quality by Design for generics. I met Inna in person at the 2013 IFPAC conference and we’ve been comrades in the QbD journey ever since. I enjoy listening to folks who...
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...