Abstract

Despite several quality management tools, none or very few systematic operations are taken into account to assure the quality of the pharmaceutical products. Plan Do Check Act (PDCA) analysis is performed based on the problems encountered during product development. In each step, some of the quality control tools are used for better maintenance of corrective and preventive actions. However, systematic use of these tools has still not been made. Here we present an example of nanoemulsion that will help justify the correct or systematic use of all the seven quality control tools in each section of the PDCA cycle for better execution of Corrective and Preventive Actions (CAPA). The major limitations associated with the nanoemulsion i.e. non-uniform size distribution, lower encapsulation efficiency, lower magnitude of zeta potential, non-scalable and expensive synthesis procedures, are taken into consideration. This review summarizes the productive use of 7 QC tools in the PDCA cycle to ensure the optimum quality of nanoemulsion in an industry.

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