Recent trends in process capability in the pharmaceutical industry

Sohail Anwer¹, Amber Ikram¹, Irum Afzal,¹ Anum Hanif¹, Farah Nawab¹

Abstract

Pharmaceutical industries are among of the largest companies. The aim of manufacturers is to produce free of defects products and make them available for consumers. A number of process monitoring and control strategies have been developed to produce quality products. Process capability indices have increased in use and variety. It is a statistical approach to inherent process variability. For this purpose, a systematic review was performed and findings were summarized. Studies have demonstrated that process capability study has improved the manufacturing process in the pharmaceutical industry. Various methods such as computing Cp and Cpk values, and applying DMAIC approach are being widely used by manufacturers to produce quality products. Process capability as a tool has been powerful enough to affirm the quality of the produced dosage form. Findings revealed that by minimizing variations, manufacturers can make processes fit for the industry and produce quality products. Literature has suggestes that the industry should conduct capability studies prior to commercializing the manufactured batch.