Process design experimental data and risk assessments are used to predict expected process performance and establish process performance qualification acceptance criteria. Per ICH Q8, the aim of ...

This past March and April, I wrote in the monthly column, Tomorrow’s Environment, about “How Much Is Too Much.” I addressed the topic of producing HVAC (heating, ventilating, and air-conditioning) ...

The author discusses the purpose of analysis and testing and the implications for specifications and their underlying statistical distribution. All measurements are ...

What are upper specification limits? During the most recent review of the process control charts, someone noticed that the process fell out of control. Thankfully, it was noted that not a single piece ...