The Use of Process Analytical Technology in Active Pharmaceutical Ingredient Process Development
نویسنده
چکیده
Process Analytical Technology (PAT) is a system for design, analysis, and control of manufacturing processes, based on continuous monitoring/rapid measurements of critical quality and performance attributes of raw material, intermediates and products. PAT involves measurement science by using conventional process sensors such as pressure, temperature and pH probes, as well as novel analyzer technologies. Demands for improved pharmaceutical productivity and quality, as well as the encouragement of recent PAT initiatives by the FDA, have caused PAT to become increasingly recognized and embraced by pharmaceutical companies in both research and manufacturing areas. The drivers for using PAT include:
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