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

DUBLIN--(BUSINESS WIRE)--The "Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)" conference has been added to ...

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 ...

In the ultra-precision machining of optical components, the checking tools are specially used to control their surface shape accuracy. As the ultra-precision core component of telescope systems, the ...

To test complex devices, test engineers must rely on the vector sets generated by verification engineers. Unfortunately, verification engineers—who work in a software simulation environment—often have ...

ASTM published Standard E3499-25 for PIP testing, enabling faster mechanical property analysis in regulated manufacturing ...

Among the first decisions to be made when initiating a composites testing program is the selection of test methods to follow. Unless performing highly customized testing, it’s usually not difficult to ...

The most probable number (MPN) bioburden test method can be a valuable tool for determining bioburden counts when the typical bioburden test methods are problematic on a particular product or when a ...