Method Development & Validation


Quality can be designed to process 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 techniques development includes modeling of the influence of variables value on quality, design of experiments, and simplification of processes as information is collected. The extension of Quality by Design philosophies is now applied on the development of manufacturing processes and analytical methods. The ability of a chromatographic technique to successfully separate, identify and quantitate species is determined by a powerful factor called experimental design. Automation of a process is one of the important keys for increasing the productivity of a research group.



 


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