QbD Dying Prematurely? Use This QbD Metric
Boss: “I haven’t seen the results yet. There are 5 other high-priority programs. How can we justify your time training scientists on QbD? Can we even measure the success this year?” QbD Manager: Its been only 6 months…I can see R&D scientists beginning to use DOE (Design of Experiments)...
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...
Risk Assessment: Why FMEA Fails [Download]
I just returned from IFPAC 2014 and will begin sharing some presentations with presenters’ consent, starting with mine. In the previous article I shared a typical scenario that a Risk Assessment facilitator may face. If you tried a FMEA-based risk assessment for QbD, you will be familiar with the...
QbD and PAT Topics at IFPAC 2014
Which QbD or PAT topics interest you? I’ll be attending the IFPAC 2014 Conference in Washington DC. IFPAC began in 1987 and is relatively a small community of Regulatory Agencies, Manufacturers and Researchers focusing on Process Analytical Technology (PAT), Quality by Design (QbD), Process Understanding & Control, and Real-Time Analytics. Sharmista Chatterjee, Ph.D....
Risk Assessment for QbD: Why FMEA Fails
If you tried a FMEA-based risk assessment for QbD, you will be familiar with the following story. Picture yourself and 4 scientists starting a meeting in a conference room at 4pm. Scenario: Fighting over a rating of 3 versus 4 Project Manager: Let’s continue our Risk Assessment using FMEA. Today...
FDA’s Quality Metrics help Quality by Design?
Are you searching for business cases for QbD to persuade senior executives? As a QbD evangelist, I am. If you are constantly trying to sell the benefits of Quality-by-Design, then FDA’s new Quality Metrics is worth a look. The new FDA Quality Metrics should help many QbD (Quality by...
Practical Tips on QbD from FDA, MHRA & EMA
This post is packed with practical tips on QbD (Quality-by-Design) and other topics, straight from the global regulatory agencies. Officials from Regulatory Agencies (FDA, EMA, MHRA) opened up the floor to the industry for questions. Since the scope was beyond QbD, I bolded the QbD-relevant questions and responses from...
No Regulatory Incentives for Quality by Design (QbD)? 10 Recommendations
Are there any regulatory incentives for Quality by Design (QbD)? The Pharma Industry is disappointed about what FDA and ICH hinted as a benefit of QbD (Quality-by-Design) — Regulatory Flexibility. “While QbD concepts described in ICH Q8(R2) and Q11 are… well accepted by FDA and Pharma, recent regulatory experience...
QbD in Biologics: Genentech’s Success and Failure in Design Space Approval
Earlier, I posted why the 1st Biologics failed in full QbD submission. Now Genentech has been redeemed and is pioneering Quality-by-Design in biologics / biotechnology / large molecule / biopharmaceuticals. Dr. Lynne Krummen of Genentech (Roche) kindly shared her experience with 2 products: Perjeta and Gazyva. Both were full-QbD...