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 ...

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

For a stable and controlled process, “process capability” (PC) refers to the least quality variability that the process can provide. In other words, the PC is the measure of a process’s ability to ...

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

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 ...