Systems Approach to Process Lifecycle Engineering in Pharmaceutical Production

In pharmaceutical industries, lifecycle management of process improvement by coordinating product design, recipe design, facility development, and production activities is necessary to develop robust and consistent production processes that satisfy requirements for product quality. The business process of pharmaceutical process lifecycle engineering is described in an activity model that defines the stages of plan-do-check-act. On the basis of this model, procedures and a change-management system in lifecycle engineering were developed. The procedures and the system can be continuously improved by the activity model-based systems approach to achieve practicable process lifecycle engineering in pharmaceutical production.