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 ...

New research paper titled “Supervised Learning for Coverage-Directed Test Selection in Simulation-Based Verification” from researchers at University of Bristol and Infineon Technologies. “Constrained ...

In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA ...

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

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 ...