Quality-by-Design (QbD) process evaluation for phytopharmaceuticals on the example of 10-deacetylbaccatin III from yew

The line of argument for basic process conception is described and initial risk assessment is shown. Typical raw material variation and vaporization are identified as causes of process variability, therefore, the implications to subsequent process steps are pointed out. Finally, influences of load and flow rate on the chromatographic separation of 10-deacetylbaccatin III are shown to exemplify sensitivity of purification design.