QbD APPROACH ON ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF FEBUXOSTAT IN ITS FORMULATIONS BY LC-MS-MS

Quality is of utmost importance in pharmaceutical manufacturing. FDA sets minimum standards, but it is up to industry to exceed these standards and develop high quality medicines. Many recent drug shortages and recalls are linked to issues with drug quality and can be traced back to failures of manufacturer's quality management systems. FDA is continuously trying to identify ways to encourage manufacturers to improve manufacturing processes to ensure consistent product quality throughout a product’s shelf life. The agency also works diligently to ensure that manufacturers identify when contamination or other production failures may occur. It is important to recognize that quality cannot be tested into products; it should be built in by design.