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....
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...
Call for QbD Consultants!
About once a month, I receive a QbD consulting request. Unfortunately, I declined them due my limited availability. One thing I did was – connect companies with a few consultants that I knew. I’d like to do this more by opening up the directory to those who need to seek QbD consultants. Are you...
How to Describe QbD — in 1 Sentence — over a Holiday Dinner
A question always comes up during holiday dinners – “What do you do again?” I begin sweating. Hmm…I have to think for a minute before I respond. Then it goes something like this: Me: “Well, you know that drugs you take are manufactured in big facilities but are designed by...
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...
Uncertainty vs Occurrence in QbD Risk Assessment
While extracting QTPP, CQA and CPP’s from the A-Vax case study, I noticed some authors used “uncertainty” instead of the popular “occurrence” for their QbD Risk Assessment. What this means is that the Risk Priority Number (RPN) equation: RPN = Severity x Occurrence becomes RPN = Severity x...
What Matters to Patients? QTPP for Vaccines: A-Vax Case Study
Many of you asked for the QbD Risk Assessment Template for Vaccines. We are happy to announce that it is now available. CMC-Vaccines Working Group published a QbD case study: A-VAX: Applying Quality by Design to Vaccines in 2012. The QTPP-CQA-CPP/CMA template is based on this A-Vax case study....