In the manufacturing industry, for example, the pharmaceutical industry, a thorough understanding of the process is necessary in addition to a properly designed monitoring and analysis system (PAT system) to consistently obtain the desired end-product properties. A model-based computer-aided framework including the methods and tools through which the design of monitoring and analysis systems for product quality control can be generated. analyzed and/or validated, has been developed. Two important supporting tools developed as part of the framework are a knowledge base and a model library. The knowledge base provides the necessary information/data during the design of the PAT system while the model library generates additional or missing data needed for design and analysis. Optimization of the PAT system design is achieved in terms of product data analysis time and/or cost of monitoring equipment subject to the maintenance constraints of the desired product quality. The application of the model-based framework is highlighted through a case study involving the operation of a fermentation process. (C) 2008 Elsevier Ltd. All rights reserved.