EVALUATION OF PROCESS CAPABILITY IN MANUFACTURE OF ANTIHYPERTENSIVE TABLETS 10 MG

Abstract

Background of the Study: A Process Capability Study is a formal procedure for undertaking a systematic investigation to reliably assess a process ability to consistently meet a specific requirement. Its indices are to measure the inherent variability of a process and thus to reflect its performance.

Objective: The present study describes the evaluation of Process capability in the manufacture of Anti-hypertensive tablets 10 mg.

Materials and Methods: This project focuses on Process Capability Study that had been applied in Pharmaceutical industry which includes selection of critical parameters, data collection, study on process capability and data evaluation. In this process capability study the critical process parameters were identified and evaluated by challenging its lower and upper release specifications. Here many statistical process control tools along with Minitab-16 software were used to find the capability of this manufacturing process.

Results and Discussion: The discovered results for Ppk (Process performance index), tolerance limit and Standard deviation (overall) are 2.25, 40 and 2.949, which advocates that the process meets the criteria required for capability. Process capability ensures that processes are fit for industry company specification while reduce the process variation and important in achieving product quality characteristic. This capability study should be employed in the industry before the batch is made commercial. It acts as a cost effective approach that can reduce the time taken for inspection.

Conclusion: In this research work the current capability of the process is predicted and the process is found to be capable.

Keywords: Process capability, Specifications, Critical parameters.