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Abstract

The pharmaceutical industry is renowned for its stringent quality standards, and ensuring medication effectiveness and patient safety. In order to achieve these objectives, quality control and assurance are crucial. Quality assurance and control are components of quality control.


The use of Quality assurance is essential in all It takes experience to manage quality in the industry. of Total Quality Management and Six Sigma, Out of Specifications (OOS), Out of Trend (OOT), and Corrective & Preventive Measures (CAPA) and ICH compliance rules perfectly. The emphasis of quality assurance is fulfilling quality requirements, while quality Assurance aims to provide reassurance that The quality standards are fulfilled. Products and services are not the only focus of management. quality as well as the methods used to attain it. To progress Industrial product and process quality, especially The automotive sector has also embraced them. by the Food and Drug Administration (FDA) of the United States for Drug discovery, development, and manufacturing.

Keywords

Quality Management, Six sigma, TQM, OOS, OOT, CAPA, ICH, FDA.

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