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

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.

Increase your chances of success and reduce costly recalls.

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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 (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.