Category: Risk Assessment

QbD Risk Assessment 2.0 — Coming Soon!

After stirring up a discussion on QbD Risk Assessment, I went quiet. Here’s why. Background: QbD at Risk I couldn’t sit through another Risk Assessment meeting. I was tired of long meetings and “most attributes are high-risk” results. The worst part — scientists did not support the process. This...

1st QbD Approval for Biologics: Gazyva Design Space

  “This will be the first OBP BLA* with an approved design space.” (CDER, *OBP: Office of Biotechology Products, BLA: Biologics License Applications). Quality-by-Design in Biologics is challenging. Skepticism prevails. (i.e. Matej Horvat’s excellent discussion). I outlined a few reasons why QbD in Biologics is challenging in an earlier article. Complexity and heterogeneity...

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)...

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...

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...