ICH Q12 Examples – Pharmaceutical Product Lifecycle Management Examples – FDA Guidance
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How To Apply QbD to Drug Device Combination Products
Today, we invite Dr. Manfred Maeder of Novartis to share how Quality-by-Design is applied in the development of medical devices and drug device combination products. Previously, Dr. Lana Shiu of FDA shared the ongoing regulatory changes in drug device combination products. I recommend you listen to her presentation as...
Minimum QbD, Enhanced QbD, and R&D QbD – How Are They Different?
I know what you are thinking. “We have no resources for implementing a full QbD. What is the minimum requirement to call our development process a QbD?” This article addresses that question. But it also provides a roadmap to enhance the “minimum QbD” over a period of time. Ildikó...
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...
Faster Drug Approvals with this underused QbD tool
“Does anyone not use QTPP?” was the original question asked to the ~21,500 scientists. Being a Quality-by-Design community, many claimed their organizations are using the essential element of QbD – the Quality Target Product Profile. Was it true? However, data tells us otherwise. Today, Adria Tyndall share her research...
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...
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...
Pedro Hernandez – A Tribute to QbD and PAT Evangelist
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...