This presentation will focus on the conceptual difference between statistical process control and statistical quality control. SPC is the application of statistical techniques and/or statistical or stochastic control algorithms to analyze leading indicators. SQC is the application of various statistical methodologies to monitor lagging indicators such as process output and all product quality attributes. Although SPC and SQC utilize similar statistical tools; distinct differences in the objectives exist between the two applications as discussed by the International Standards Organization (ISO, 11462-1:2009).
This video is part of an educational series presented by AAPS. Stats Snax discusses basic statistical concepts that apply to the pharmaceutical industry using examples from CMC development areas. Designed for non-statisticians, you will learn foundational concepts that CMC statisticians encounter in their daily interactions with clients. If you have ever wondered, “What is a p-value?” or “How is expiry determined?” – This series is for you!