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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 of Implementing QbD Frameworks

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Understand Your Process

Identify the critical sources of process variability.

Ensure Reliability

Ensure Reliability

Predict your product safety and efficacy in the development stage.

Control Risk

Control Risk

Define a control strategy to mitigate the risks that can affect product performance.

Reduce Drug Development Timelines and Costs

Reduce Timelines

Reduce drug development timelines and costs while reducing costly recalls.

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Digital CPV Quality Risk Management

Margarida Ventura

Senior Consultant

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

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

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

The Value of QbD Frameworks Implementation

Before After
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 and better chance of success.
Time of drug development may be longer due to failures. Shorter development timeline and reduced time to market.

Dive Deeper Into QbD Frameworks

Blog Post
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
Industry Insight
A Roadmap for Implementing Analytical QbD

Read the Industry Insight
Webinar
Integrating ValGenesis iRisk with Process Insight to Address Subjectivity

Watch the Webinar

Talk to us to see how ValGenesis can help build quality into your product from the development stage.