(166a) Design Space Continuum: From Drug Substance to Drug Product

Recognising that drug production is a continuum that spans from Drug Substance to Drug Product, will result in the development of a more versatile and robust Design Space.

The final product that delivers the active pharmaceutical ingredient to a patient, is indeed a multidimensional combination of the raw material attributes and the process parameters of several unit operations including those of the drug substance production (like reaction and crystallization), the ones from drug product production (like granulation and compression) but also packaging. Each one of the unit operations has an impact on one or more final product quality characteristics like dissolution and uniformity, but also on stability.

Therefore, if the Design Space is addressed in a holistic form, then all raw material and unit operations involved in the production and their interactions should be considered.