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...
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...
FDA Reviewer Reveals Tips on QbR for Drug Substance
Are you in the Generics industry? Then you should be familiar with QbR for Drug Substance. Barbara Scott of OGD (Office of Generic Drugs) at FDA shares insider’s tips on how to successfully file a Question based Review submission. She breaks down the questions regarding Drug Substance in Sections...
FDA Reviewer’s Checklist: QbR for Drug Products
What does a FDA reviewer look for in a (Question-based Review) QbR for Drug Products? Jennifer Maguire PhD from the Office of Generic Drugs (OGD) reveals her checklist for ANDA. In this post, Dr. Maguire shares: What information all applications should contain. What are the key questions that FDA reviewers...
QbR 2014 Vision of ONDQA FDA
I apologize for the delayed posting. I was out of commission with a severe flu for a week. Now I’m back with energy and enthusiasm to share. One exciting announcement: In a few weeks, QbDWorks will begin an Audio Series which contain personal interviews with QbD experts in our...