3 Tips from FDA and EMA on QbD Risk Assessment for Regulatory Submissions
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....
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....
QbD Case Study – ACE Tablets – QTPP, CQA, CPP, CMA
If you are in the generics industry, you should know about the QbD case study on ACE Tablets. CMC-IM working group published a QbD case study on Acetriptan or “ACE Tablets” in 2008. This article covers: Typical Approach of QbD Case Studies Process Map of ACE Tablet Manufacturing...
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...