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...
QbD Publications and Literature
Are you applying Quality by Design in: Blending, Granulation, Milling, Compression, Packaging, Cell Culture, Chromatography, Filtration, Purification, Formulations, Lyophilization, Analytical Chemistry, CMC, Assay Development? Do you plan to publish a Quality by Design article and want to know which journals to submit to? Do you have a publication related...
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...
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...
Common Pitfalls of QbD Initiatives – Shotgun Approach and Hype Cycle
I’ll begin sharing some common pitfalls of QbD initiatives that I have observed over 10 years. Meet Andy, a director who has been recently hired to kick off a Quality-by-Design initiative for PlaSeeBo Pharmaceutical Inc.’s R&D organization. He comes from Quality Assurance and Operations background. He is highly motivated to...
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....
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....