Performance metrics for processes are an area of much regulatory interest currently. There isn’t always a readily available clear definition of what is needed, however, and guidance from regulators is ...

A quantitative approach for linking baseline sample size to statistics provides a statistically justified basis for ...

Statistical techniques have a beneficial effect on measuring process variability, analyzing the variability concerning product requirements, and eliminating the variability in product manufacturing.

Physical processes in the quantum regime possess non-classical properties of quantum mechanics. However, methods for quantitatively identifying such processes are still lacking. Accordingly, in this ...

This study examines the use of process capability index results to establish sampling strategies for new product cleaning and to minimize the risk of insufficient cleaning. Pharmaceutical development ...