Laboratory-based design verification testing (DVT) of combination products and medical devices must be performed to demonstrate that the device meets the performance requirements that were set in the ...

The Food and Drug Administration (FDA) recently issued a final guidance document, Validation and Verification of Analytical Testing Methods Used for Tobacco Products. This nonbinding guidance provides ...

Producing cGMP biopharmaceutical products requires controlled, consistent performance of the manufacturing process. cGMP also requires controlled, consistent performance of analytical test methods.

Validation ensures that a part will operate correctly in end-user applications. Design validation is the task of testing a part or a system adequately to ensure that all parts or systems manufactured ...

The "Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH) - Seminar Materials" report has been added to Research and ...

As technology capabilities and customer requirements have evolved, so have gas turbine testing and validation methods. Mitsubishi Hitachi Power Systems believes the proof of its long-term validation ...