Focus is now on process validation. It is very important to review with customers quantities planned for launch and thereafter, as it can mean additional scale-up work in order to satisfy requirements in year 2 and later. If discovered at this early stage, an increase in batch size can be included in the documentation already at the filing stage.

Accordingly, the deliverables of “Product Concept 3” stand  for a validated, robust, economic feasible and economically acceptable process with a batch size usually in the range of several hundred kilos. All analytical data are now stored electronically and can be used anytime for statistical research, like trend analysis, “Out-of-Spec”-investigations as well as economical evaluations.

Very often, the development process does not stand still at this stage. It continues with a mutually agreed costs saving program, in which the process is improved in incremental steps over time, which results in higher yields, reduction of raw materials and wastes and enhances overall economy.