QbD: Process & DS characterisation
How can critical process parameters be reliably identified and controlled?
Service Description
Many development processes are based on sequential individual experiments, which means that interactions are overlooked and critical factors are not clearly identified. Approach Through structured experimental design (DoE & QbD), multiple process parameters are investigated simultaneously and their main effects and interactions are quantified. On this basis, a statistically sound understanding of the process is developed and a controlled design space (DS) is established. Result Identification of Critical Process Parameters (CPPs) Quantification of parameter interactions Derivation of a robust Design Space Added value Reduced development effort Increased process robustness Basis for regulatory submissions in accordance with ICH Q8 Pharmaceutical Development Translated with DeepL.com (free version)