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Retrospective QbD Implementation

Ensure the success of your post-approval change projects by implementing retrospective Quality-by-Design into your legacy processes.

Benefits this Solution Provides

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Develop Robust Control Strategies

Formally establish CQAs, CPPs, and the quality target product profile.

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Upgrade Your Process Knowledge

Close gaps in process knowledge by fully understanding their history in context.

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Build Continuous Process Verification Plans

Easily access critical quality information to create better CPV plans.

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Guarantee Agile Lifecycle Management

Enable science- and risk-based post-approval change plans that align with ICH Q12.

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Support all of Your Processes

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  • Ensure legacy products have robust control strategies.   
  • Understand the risks that can influence product quality.  
  • Reduce the number of costly physical experiments with in silico testing.  

Submit Post-Approval Changes with Confidence

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  • Ensure the formal assessment of the critical quality attributes (CQAs) and critical process parameters (CPPs).  
  • Define the quality target product profile (QTPP).   
  • Address the risks that impact product quality and consistency. 

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Facilitate Continuous Improvement

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  • Understand and monitor process variation using multivariate data analysis tools, process analyzers, PAT tools, and knowledge management platforms.  
  • Boost your ability to correct issues and improve performance through increased process knowledge.  

What Can You Expect From Implementing Our Solution?

Before After
Quality is tested during the final control and release of a product.  Quality is built into the lifecycle of the product. 
Flexibility is limited (when a change is needed, the regulatory process is restarted).  Supports a flexible approach that allows for continuous improvement.  
There are challenges submitting a post-approval change management project due to undefined risk management. Quality and risk are embedded in the process, streamlining post-approval change.

Learn More From Our Experts

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Blog Post

Digital CPV

What is a Multi-Site Digital CPV, and Why Should You Want It?

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Industry Insight

Risk and Data as Knowledge Enablers: A Lifecycle Approach

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Webinar

Challenges and Solutions: A Deep Dive Into Digital CQV

Watch

See how ValGenesis can support your implementation of retrospective quality by design into legacy processes.