Manufacturing quality evaluation is a critical discipline that focuses on assessing a process’s ability to produce outputs within pre‐defined tolerance limits. Recent advances combine traditional ...

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 ...

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 ...