Developing a Simplified Model Standard Operating Procedure to Implement Quality Metrics for Pharmaceutical Manufacturing System

This article addresses the values to create a Standard Operating Procedure of quality metrics for Pharmaceutical Manufacturing System, establish regulatory requirements for quality metrics, and then research the chosen metrics parameters in small-scale manufacturing industry. Quality metrics are used to assess how well various processes and systems are working in the pharmaceutical industry, including the quality control system. The quality metrics for the continual improvement of medicines contain systematic and precise representations of all quality management operations. The experimental work included seven quality metric parameters (lot acceptance rate, product quality complaint rate, valid out of specification rate, invalidated out of specification rate, production disposition cycle rate, product recall rate, and field alert rate), and all of the quality metric parameters were then calculated month by month (Six month). Seven quality Metrics parameters were trended throughout the six months for the project’s ultimate results, and the percentage of parameters was calculated. Based on the findings of the Quality Metrics, remedial and preventive actions were suggested.