Quality assessment support system and its use in pharmaceutical plant operations

On the basis of the quality by design approach, aggregation of knowledge in process chemistry and manufacturing operations is essential for the continuous development of pharmaceutical products and processes. We develop a model-based framework to describe process chemistry oriented phenomenal sequences leading to quality hazards (process deviation scenario), which should be independent of any specific plant structural information, and manufacturing procedural error oriented event propagations (procedural control scenario), which concern a specific plant structure. We propose a system, Quality-HAZOP, to analyze the scenarios in which manufacturing errors can affect product quality via complex propagation pathways. This system supports bidirectional improvement proposal between recipe scientists and process engineers. This proposal triggers risk information exchange that supports the continuous improvement of the process in life-cycle pharmaceutical development.