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...

Quality in Pharmaceutical Industry – Literature Review

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...

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...

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...

FDA Quality Metrics – How to use it as a Business Case for QbD

Question: What was the most popular topic in the last 2 years of pharmaceutical conferences? Hint: ISPE, PDA, IFPAC conferences have been highlighting this topic that some even created  conferences dedicated to this topic. Answer: FDA Quality Metrics. Quality Metrics is a “quality” report card of companies, products and facilities....