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

icon-analytical-method-qbd-01

Minimize Out-of-Specification Results

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

icon-analytical-method-qbd-02

Increase Regulatory Flexibility

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

icon-analytical-method-qbd-03

Reduce Drug Development Timelines and Costs

Increase your chances of being successful and reduce costly recalls.

icon-analytical-method-qbd-04

Ensure Performance

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

1-improve-analytical

Improve Analytical Method Development

_________

  • 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

_________

  • 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).   

2-science-risk-approach
3-control-stategy

Control Strategy and Continuous Method Lifecycle Management

_________

  • 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

Blog post icon

Blog Post

Digital CPV

Enhancing Continuous Manufacturing with Digital CPV Integration

Read More


Industry Insight icon

Industry Insight

PAT Implementation

A Roadmap for PAT Implementation

Read More


Webinar icon

Webinar

Diving Into the Nexus of Life Sciences and Next-Gen AI

Watch

See how ValGenesis can support your digital transformation.