Method validation is recognised as an essential part of good measurement practice. It cannot be guaranteed that analytical data will be fit-for-purpose unless the performance of the test method has ...

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

As drug development becomes more complex, so do the demands for accurate, reproducible bioanalytical data to prove their safety and efficacy. Method validation ensures the reliability of ...