Method Development & Validation

Quality can be designed to processes through systematic implementation of an optimization strategy to establish a thorough understanding of the response of the system quality to given variables, and the use of control strategies to ensure quality. The concept of method development includes modelling of the influence of values of variables on quality, design of experiments, and simplification of processes as information is collected. The extension of QbD (Quality by Design) philosophies is now applied to the development of manufacturing processes and analytical methods. The ability of a chromatographic method to successfully separate, identify and quantitate species is determined by a powerful factor called experimental design. Automation of a process is one of the keys for increasing the productivity of a research group.

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