Knowledge management and process monitoring of pharmaceutical processes in the quality by design paradigm.

Pharmaceutical processes are complex and highly variable in nature. The complexity and variability associated with these processes result in inconsistent and sometimes unpredictable process outcomes. To deal with the complexity and understand the causes of variability in these processes, in-depth knowledge and thorough understanding of the process and the various factors affecting the process performance become critical. This makes knowledge management and process monitoring an indispensable part of the process improvement efforts for any pharmaceutical organization.