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

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 ...

A Standard Test Method is a conclusive procedure that yields a test result. So as to achieve accurate and relevant test results, a standard test method is definite, unambiguous, and experimentally ...