QbD Frameworks Implementation
Use the best technology to design quality into your product during the development stage, improving your time to market while saving cost.
Benefits this Solution Provides
Understand Your Process
Identify the critical sources of process variability.
Predict your product safety and efficacy in the development stage.
Define a control strategy to mitigate the risks that can affect product performance.
Reduce Drug Development Timelines and Costs
Increase your chances of success and reduce 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.
What Can You Expect From Implementing Our Solution?
|Quality is tested during the final control and release of a product.||Quality is built into the development stage of the product.|
|Limited flexibility (when a change is needed, the regulatory process is restarted).||Flexible approach that allows for continuous improvement.|
|Higher cost of drug development (higher chance of costly recalls).||Lower cost of drug development (better chance of success).|
|Time of drug development may be longer due to failures.||Shorter development timeline and reduced time to market.|
|Before||Quality is tested during the final control and release of a product.|
|After||Quality is built into the development stage of the product.|
|Before||Limited flexibility (when a change is needed, the regulatory process is restarted).|
|After||Flexible approach that allows for continuous improvement.|
|Before||Higher cost of drug development (higher chance of costly recalls).|
|After||Lower cost of drug development (better chance of success).|
|Before||Time of drug development may be longer due to failures.|
|After||Shorter development timeline and reduced time to market.|
See how ValGenesis can support your digital transformation.