Category: Risk Assessment

  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...

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...

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....

Previously, we learned: To use a RPN scale commensurate at the level of information available. If you are in development stage, High-Med-Low is recommended. When discussing Control Strategy, separate the rankings of Severity and Occurrence. At the development stage, the main goal of Risk Assessment in Quality by Design...

You heard the story about the troubled QbD Risk Assessment meeting.  Picture yourself and 4 scientists starting a meeting in a conference room at 4pm. Scenario: Fighting over a rating of 3 versus 4 Project Lead: Let’s continue our Risk Assessment using FMEA. Today we’ll assess the severity of Quality Attributes to...

If you are applying QbD for Vaccines, this presentation will be helpful. Dr. Hyun Sung Kim presented a summary of A-VAX case study at KOBIA 2014. Dr. HS Kim (HS from hereon) is the Quality Director at Green Cross, Korea. I share my notes with you.  As with any...

I reveal 2 secret practices today – 2 practices that will set your QbD initiative up for success. I call them secrets because they are the most uncommon QbD practices – especially in the United States, where I work and reside. As facilitators of QbD risk assessment meetings, not...

Thanks to you, your company just saved $56,400 in variable cost and $15 Million in opportunity cost. This comes from eliminating 9 unnecessary group meetings, 12 hours of individual work and a minimum of 3 weeks of delay time to market launch. In Steps 1 and 2, we assessed...

If you’ve experienced Risk Assessment sessions, you will be familiar with how much time is spent at the beginning — just trying to collect the QTPP, CQA and CPP’s. The good news is that most products (biologics and small molecules) share similar manufacturing processes. Accordingly, they share similar sets...

Have you led or supported a QbD project? Then you will agree that Risk Assessment is a critical piece — like the small hinge that a big door (QbD) revolves around. The activity may seem trivial but has major implications.  In fact, QbD revolves around risk assessment. If you...