ABSTRACT
Discovery and formulation are precursors to manufacture any new pharmaceutical medicament. Manufacturing for sale and distribution is the ultimate endpoint of development processes. The clinical trials material professional should examine all phases of development for potential hazards that may emerge or enlarge during the manufacturing process. Process Analytical Technology (PAT) may discern potential problems early in the process. Information technology can ease the transition from clinical trials through scale-up and help manage data and distribution during clinical trials. Both of these can simplify regulatory hurdles. The clinical trials material professional can utilize all these tools within development and manufacturing.
