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.

U.S. regulators are advancing efforts to scale back animal testing, with the FDA proposing reduced primate studies for monoclonal antibodies and the EPA planning phased cuts to vertebrate use in ...

Biotia, a company advancing infectious disease diagnostics for challenging infections, today announced the publication of a pivotal clinical validation study in the American Society for Microbiology ...

An expert illustrates why test method validation is important in the real world. José Ignacio Mora Tom was ready to send the multi-cavity fixtures. I asked him to perform a Gage Repeatability and ...

NI CHESS enables flexible software-driven, lab-based RF validation to reduce costs and risks of field testing.

Development of a new automated test method to measure the wax appearance temperature (WAT) of opaque crude oils with 1.0° C. precision used a modified version of American Society of Testing and ...

When clinicians contemplate the use of a new predictive technology in their practice, such as a nomogram, there is always a question of whether the new test is beneficial to their own clinical ...

This is something I have heard a lot recently. But it’s not true. The Quality System Regulation 21 CFR Part 820 includes requirements for design controls. The regulation requires design validation to ...