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...

Quality in the Pharmaceutical Industry – A Literature Review Here is a Literature Review on the topic of Quality in the Pharmaceutical Industry. It is not specific to Quality by Design (QbD) or (Process Analytical Technology) PAT. However the literature review does have a small section on both QbD...

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...

Our fellow QbD evangelist –  passed away this month. He will be missed by many of us. My friend, Mehtap Saydam suggested we reflect on Pedro’s contribution as a community with Pedro’s family at this time.   Pedro presenting at a conference   Urn of Pedro with his family...

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...

“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...

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...

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...

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....