The Significance of Quality Metrics in a Pharmaceutical Quality Management System – A Case Based Study

Abstract:

Background: The pharmaceutical quality management system is a concept of management function that design and implement the “Quality policy”. The pharmaceutical manufacturing industries all over the world have just begun to apply the United States Food and Drug Administration (USFDA) guidelines in the 21^st century. The study tries to identify the quality metrics based on Quality Indicators for a pharmaceutical industry and to investigate the utilization of quality KPIs. Methodology: The work experience from a successfully working pharmaceutical organization related to Research and and Development (R&D) of pharmaceutical products are discussed here. Important areas were identified and analysed based on the data collected from the deviation reports of selected organization and other resources. The R&D centre uses a software system for Quality management system including, Deviation management, Change management, Laboratory investigation, Incident management and Corrective Action and Preventive Action (CAPA). Results: The primarily considered Quality indicator (QI) was the pharmaceutical deviation. A Among the deviations reported in the year of 2017-18, 214 cases were selected as sample. In this 171 were permanent deviations and 43 is temporary deviations. Secondarily, Pharmaceutical incidents are selected for the study as the QI in which 70% of the root cause is due to human related issues. Failure to meet acceptance criteria comes first with 48% and failure to follow procedure with 28%. Conclusion: A good quality metrics system supports both industries’ profitability, GMP compliance and precludes overproduction of metrics; only measure what adds value to quality in the most efficient way.

Key words: Quality Metrics, CAPA, Key performance indicators, Deviation, Change control.