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...
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...
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...
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...
QbD for Pharmaceutical Legacy Products
How do you apply Quality by Design for pharmaceutical legacy products? Today, my good friend, Alicia Tebar of ISPE Spain share her QbD project on legacy products – using QbD and Six Sigma tools. Quality by Design is different from Six Sigma – but they do share many tools....
FDA on Prefilled Syringes and Combination Products — What This Means for You
This regulation affects all of us. Most of us focus only on one of these: Drugs, Therapies, or Devices. However unexpected failures and mistakes happen more often at the interface of the three, shares Dr. Lana Shiu of CDRH at FDA. I met Dr. Lana Shiu after her presentation at...
QbD: Past, Present and Future by Anurag Rathore
I am thrilled to have Dr. Anurag Rathore share his QbD journey with our QbDWorks community. This is a followup to the previous post. This is a part of QbDWorks interview series where we interview the thought leaders of Quality by Design to discuss what works and what doesn’t in QbD....