EMA Q&A: Enhancing Understanding of NOR, PAR, DSp, and Process Parameter Normal Variability
1. What is the Normal Operating Range (NOR), and how should it be presented in marketing authorization application documents? Answer: NOR is not a defined ICH term.NOR describes a region around the target operating conditions that encompasses normal operational variability (i.e., variability that cannot always be controlled). Multiple process parameters of the same process step … Read more