Questions and answers: improving the understanding of normal operating range (NOR), proven acceptable range (PAR), design space (DSp) and normal variability of process parameters (EMA/CHMP/CVMP/QWP/354895/2017)

Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pre-authorisation-guidance).

Organisaties:

EMA