(483a) The Final Step of a QbD Technical Transfer: Validation

The final step in a Quality by Design (QbD) pharmaceutical technical transfer process is Validation.  Now that submitted QbD process what does it take to complete a QbD validation? The “Traditional” 3-Batch Validation has been a standard over the decades which implies a controlled product that meets release specifications; but how does one move away from a 3-Batch validation to continuous verification?  In addition is there a requirement to move away from this type of validation? Finally once the process is validated, what’s next?  Presented will be an approach to answering these questions to finalize a successful technical transfer.