Quality Assurance: Role in the Pharmaceutical Industry

Abstract

Quality management system is an integral part of quality assurance. The main purpose of quality standards is to provide consumer satisfaction. Quality management of pharmaceutical products was started with production premises based on the principle of good manufacturing practices (GMP) and Food and Drug Administration (FDA) regulating bodies. Quality policy controls all critical points starting from raw material, in-process check, equipment, production, packaging material, and packing of finished goods till dispatch. The goal of quality assurance is to ensure that pharmaceutical manufacturing is done with safety, identity, quality and compliance with marketing values. It describes various documentation, records, procedures, and implementation of written procedures (SOPs) to maintain uniformity for the proper functioning of the system. The main aim of quality assurance is to prevent defects rather than detection of mistakes. According to ISO, quality management focuses on providing confidence that quality management will be improved. The process of quality assurance is to identify and analyze the information and judge the quality. The principle of quality assurance is on customer focus, leadership, process approach, continual improvement, and mutual benefit between customer and company. Quality assurance is the heart and soul of quality control. It is the sum of quality control and good manufacturing practices and another related quality system. Under the quality system products designed and controlled operations are specified in written form. There is a procedure of self-inspection for the effective evaluation of pharmaceutical quality products. There is regular evaluation and analysis of deviations and incidents, out-of-specification/trends, and change control during the manufacturing of drugs. Quality assurance staff is present everywhere to monitor each activity of the organization. So, it is considered as backbone of pharma companies without this they will be unable to manufacture products