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Analytical Method QbD Implementation

Develop your analytical method to meet the desired analytical target profile (ATP) and improve its robustness for resource-efficient drug development.

Benefits this Solution Provides

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Minimize Out-of-Specification Results

Design the method to meet expected performance criteria, maximizing cost savings.

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Increase Regulatory Flexibility

Make easier post-approval changes by knowing what can impact critical method attributes.

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Reduce Drug Development Timelines and Costs

Increase your chances of being successful and reduce costly recalls.

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Ensure Performance

Ensure the performance of your methods throughout their lifecycle, defining an ACS to mitigate risks.

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Improve Analytical Method Development

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  • Define the ATP to ensure the chosen method is fit for purpose and compliant with regulatory guidelines.  
  • Use knowledge management techniques and quality risk management tools to find the analytical method most likely to meet the desired ATP for the chosen process.  

A Science- and Risk-Based Approach

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  • Perform a risk assessment to quickly identify the critical method attributes (CMAs) and the critical method parameters (CMPs).  
  • Take full advantage of scientific and prior knowledge to identify parameters significantly impacting CMAs. 
  • Define the method operable design region (MODR) with the initial risk assessment and adequate experimental testing using tools such as design of experiments (DoE) and multivariate data analysis (MVDA).   

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Control Strategy and Continuous Method Lifecycle Management

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  • Review the risk assessment and, if necessary, update CMPs, CMAs, and MODR.  
  • Define an analytical control strategy (ACS) to mitigate risks and ensure the method performs as expected throughout the entire lifecycle.  
  • Formally demonstrate that the analytical method fits your defined purposes and the ACS is appropriate and robust enough to validate your method.  
  • Continuously monitor your analytical method performance.  

What Can You Expect From Implementing Our Solution?

Before After
Method performance is measured after its development. Analytical method development is designed to meet expected performance criteria.
Limited flexibility. Flexible approach that allows for continuous improvement.
Higher cost of drug development (higher chance of costly recalls). Reduce the cost of drug development (increase your chance of success).
Time of drug development may be longer due to failures. Shorter development timeline and reduced time to market.

Learn More From Our Experts

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Blog Post

Digital Validation

Launching Digital Validation: MilliporeSigma's 97-Day Implementation Success Story

Read the Blog Post

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Industry Insight

Transforming Pharmaceutical Development: Combining Digital Platforms and QbD Principles

Read the Article

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Webinar

How to Digitally Optimize Comparability for More Effective Post-Approval Change Management

Watch

See how ValGenesis can support your digital transformation.