Benefits of Implementing QbD Frameworks
![icons-qbd-frameworks-01](https://www.valgenesis.com/hs-fs/hubfs/vg-theme/vg-solutions/qbd-frameworks/icons/icons-qbd-frameworks-01.png?width=150&height=150&name=icons-qbd-frameworks-01.png)
Understand Your Process
Identify the critical sources of process variability.
![Ensure Reliability](https://www.valgenesis.com/hs-fs/hubfs/vg-theme/vg-solutions/qbd-frameworks/icons/icons-qbd-frameworks-02.png?width=150&height=150&name=icons-qbd-frameworks-02.png)
Ensure Reliability
Predict your product safety and efficacy in the development stage.
![Control Risk](https://www.valgenesis.com/hs-fs/hubfs/vg-theme/vg-solutions/qbd-frameworks/icons/icons-qbd-frameworks-03.png?width=150&height=150&name=icons-qbd-frameworks-03.png)
Control Risk
Define a control strategy to mitigate the risks that can affect product performance.
![Reduce Drug Development Timelines and Costs](https://www.valgenesis.com/hs-fs/hubfs/vg-theme/vg-solutions/qbd-frameworks/icons/icons-qbd-frameworks-04.png?width=150&height=150&name=icons-qbd-frameworks-04.png)
Reduce Timelines
Reduce drug development timelines and costs while reducing costly recalls.
Fully Understand Your Product and Processes
- Start your process development with a complete understanding of your product and its manufacturing processes, ensuring they meet patient needs.
- Establish a framework for the design and implementation of a process that achieves a consistent level of quality and always meets predefined criteria.
![Establish a QbD framework](https://www.valgenesis.com/hs-fs/hubfs/vg-theme/vg-solutions/qbd-frameworks/images/1-fully-understand.webp?width=700&height=410&name=1-fully-understand.webp)
QbD: a Process that Focuses on Risk Assessment
- Collect data and perform a risk assessment to establish the quality target product profile (QTPP) detailing the product’s desired characteristics; identify critical quality attributes (CQAs) and critical process parameters (CPPs).
- Identify risks that impact product consistency and quality and define which variables can change without affecting the drug’s safety or efficacy to design a control strategy.
![QbD: a Process that Focuses on Risk Assessment](https://www.valgenesis.com/hs-fs/hubfs/vg-theme/vg-solutions/qbd-frameworks/images/2-qbd-risk-assessment.webp?width=700&height=410&name=2-qbd-risk-assessment.webp)
Achieve Continuous Improvement
- Increase your level of knowledge in each development phase and adjust your risk assessment to correct any possible issues.
- Be able to understand and monitor process variation using multivariate data analysis tools, process analyzers, PAT tools, and knowledge management platforms.
![Achieve Continuous Improvement](https://www.valgenesis.com/hs-fs/hubfs/vg-theme/vg-solutions/qbd-frameworks/images/3-achieve-improvements.webp?width=700&height=410&name=3-achieve-improvements.webp)
Dive Deeper Into QbD Frameworks
Blog Post
Industry Insight
Webinar
![](https://www.valgenesis.com/hs-fs/hubfs/vg-theme/vg-blog/00-webp/cell-gene-therapies.webp?width=403&height=212&name=cell-gene-therapies.webp)
Cell & Gene Therapies: is Quality by Design Ready for it?
In this blog post, we want to discuss about the application of the Quality by Design for Cell & Gene Therapies. Are they suited for them?
Read the Blog Post![](https://www.valgenesis.com/hs-fs/hubfs/vg-theme/vg-resources/industry-insight/thumbnails/resources-a-roadmap-for-implementing-analytical-qbb.webp?width=403&height=212&name=resources-a-roadmap-for-implementing-analytical-qbb.webp)
A Roadmap for Implementing Analytical QbD
Read the Industry Insight![](https://www.valgenesis.com/hs-fs/hubfs/vg-theme/vg-resources/webinars/thumbnails/thumbnail-webinar-integrating-irisk-with-process-insight.webp?width=403&height=212&name=thumbnail-webinar-integrating-irisk-with-process-insight.webp)
Integrating ValGenesis iRisk with Process Insight to Address Subjectivity
Watch the WebinarTalk to us to see how ValGenesis can help build quality into your product from the development stage.