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 ...

Leak detection plays a critical role in ensuring packaging reliability, especially in industries where product integrity directly affects safety, sterility or shelf life.

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 ...

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 ...

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 ...

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 ...

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 ...