ICH Q12 Examples – Pharmaceutical Product Lifecycle Management Examples – FDA Guidance
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Pharmaceutical Quality by Design Book – Practical or Theoretical? [Interview]
A new book on Quality by Design was recently published. When I read such a book on QbD, I ask – “is it merely theoretical or actually practical?” As a scientist who deals with the reality of messy biologics and constraints of time and resources at the office, I...
Influenza vaccines – Quality module
Recently, EMA (European Medical Agency) published a Guideline on Influenza Vaccines – Quality Module. Though the main focus of this EMA guideline was not QbD or PAT, one section – 4.1.1.6. Characterisation – was relevant to QTPP, CQA, CPP and hints on the details of the design space (albeit...
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...
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...
QbD Publications and Literature
Are you applying Quality by Design in: Blending, Granulation, Milling, Compression, Packaging, Cell Culture, Chromatography, Filtration, Purification, Formulations, Lyophilization, Analytical Chemistry, CMC, Assay Development? Do you plan to publish a Quality by Design article and want to know which journals to submit to? Do you have a publication related...
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...
QbD Design Space for Analytical Assay — Screening DOE [Tutorial]
I’m excited to share a Case Study on QbD Design Space for Analytical Assay — Screening DOE. Dr. HS Kim from Green Cross kindly shared his slides titled: “QbD using Design of Experiments Application for Analytical Assay.” The data of the experiment comes from Experimental Design in Biotechnology (Statistics: A Series...