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.
To make this a learning experience, I’d like to unveil the extraction process so that you can understand the granular steps behind the QbD case studies. During this process you can appreciate the effort that went into these case studies and more importantly, recognize some room for improvement.
Most importantly, I’m seeking your feedback on what QTPP should be.
Needless to say, we should take all case studies with grain of salt and not blindly copy them. We need to extract the principles and modify the strategy and tactics to our own projects.
For a QbD case study in Vaccines, A-VAX provides a detailed example. However, with any case study, there is room for improvement and I’d like to begin to go over a few with you.
So let’s begin with the first step – QbD Risk Assessment for A-VAX. This is just part 1.
(I’m traveling at this time so please bear with me as I catch up with my backlog of postings.)
QTPP = What Matters to Patients?
In ICH Q8, QTPP is defined as “a prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality, taking into account safety and efficacy of the drug product.”
A-VAX first defines the QTPP (Quality Target Product Profile). QTPP should be the Product Description or Voice of Patients and Clinicians.
In current QbD case studies, QTPP typically equates to the Drug or Therapy Label. A-VAX is no exception.
A-VAX’s Target Product Profile (TPP) is a summary of its vaccine development program – only limited to labeling content. Later this table is extracted to QTPP.
|Mechanism of Action||
|Indication||A-VAX is indicated for the active immunization of 2-month-old to 60-month-old infants for prevention of cooties-related illnesses caused by X. horrificus|
|Key Claims||Has a favorable risk-benefit profile
|Secondary Endpoints||Analysis supportive of primary endpoint in target population
|Approvals and Recommendations||
After the Phase 2 clinical trials data, the team defines the QTPP (Quality Target Product Profile).
Clinical results show an 87% response rate for each serotype. (Refer to Table 2-2: Assumed Seroresponse Rates*) and reactogenicity profile (Table 2-3: Assumed Reactogenicity, Infant Stage*) for further details.
So the QTPP for A-Vax becomes:
In the next article, I’ll write further on how A-VAX co-authors attempted to connect QTPP to CQA’s and CPP’s or CMA’s. While the effort was appreciated, the approach seemed disjointed and complex mainly because of the process-silo’ing approach.
Since I am a fan (like you) of the simple and lean approach to QbD Risk Assessment, I extracted all the information for our QbDWorks community.
You can get the QTPP-CQA-CPP/CMA template here. It took a fully-burdened 60 hours to go through the 381 pages, so I think you’ll save quite a lot of time and eye strain.
What Should (or not) be in QTPP?
During Pre-filled Syringe and Combination Products Conference, some folks asked,
“should we limit QTPP to only the drug label?”
“Aren’t we still in development mode, where we still have some room for other considerations such as the comfort of administration, or even business metrics? After all, other industries begin with “Voice of Customer” (Patient and Clinician in our case).”
For drug or therapy delivery QTPP’s, we could certainly add more patient-experience factors such as “ease or comfort of administration.”
Now I’m reaching out to you for your opinions. For those who are working with Vaccines, what should be in or out of the QTPP?