Concept of process capability indices as a tool for process performance measures and its pharmaceutical application

Abstract

The main objective of the present study is to present the concept of process capability and to focus its significance in pharmaceutical industries. From a practical view point, the control charts (such as X and R hart) sometimes are not convenient summary statistics when hundreds of characteristics in a plant or supply base are considered. In many situations, capability indices can be used to relate the process parameters. The resulting indices are unit less and provide a common, easily understood language for quantifying the performance of a process. Process capability indices (PCIs) are powerful means of studying the process ability for manufacturing a product that meets specifications. Several capability indices including Cp, Cpu, Cpl and Cpk have been widely used in manufacturing industry to provide common quantitative measures on process potential and performance. The formulas for these indices are easily understood and can be directly implemented. A process capability analysis compares the distribution of output from an in-control process to its specifications limits to determine the consistency with which the specifications can be met. The process capability is also having a significant role in pharmaceutical industry. Process capability indices can be a powerful tool by which to ensure drug product quality and process robustness. Determining process capability provides far more insight into any pharmaceutical process performance than simply computing the percentage of batches that pass or fail each year.
 Keywords: Process capability; Cp/Cpk; Pp/Ppk; Pharmaceutical quality, process robustness, specification