Benefits of Implementing QbD Frameworks
Understand Your Process
Identify the critical sources of process variability.
Ensure Reliability
Predict your product safety and efficacy in the development stage.
Control Risk
Define a control strategy to mitigate the risks that can affect product performance.
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.
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.
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.
Talk to us to see how ValGenesis can help build quality into your product from the development stage.