Review on statistical methods applied in pharmaceutical quality control and quality assurance

Abstract

Global competitions have made the pharmaceutical industry undergo numerous obstacles to meet up with the pace of drug discovery, growth and expansion. In order to effectively manufacture a quality product, statistical methods can be implemented for continuous improvement. Evolution in quality is accessed by determining the beneficial effects due to changes in process performance. The use of statistical tools and statistical methods have increased exponentially to meet specifications of quality during the development of pharmaceutical product. Statistical process control is a segment of industrial statistics utilized for the continuous improvement in the product quality. Statistical process control technique is a method to analyse any variation by the process of timely evaluation of the manufacturing procedure.