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.

Pharmaceutical Quality Management System Software: A Review and Its Importance in Pharmaceutical Industries

“…It includes: auditing procedures, manufacturing, ISO requirements, protocols and specific regulations related to industry. QMS Software provides a controlled manner in which quality, efficacy of a product can be managed properly throughout product lifecycle [20] . Properly organized (QMS) Software can help in ensuring continuous improvement of quality and proper management of various processes and tasks.…”

“…Corrective and preventive action (CAPA) management [9] . Use of QMS Software helps in increasing productivity and helps in integration of various processes from all the parts of an organization [9] .Thus, a proper implementation of QMS Software can bring compliance with industry standards, scope for continuous improvement, new innovations, proper decision making, and enhancement of product, processes and system [20].…”

Importance of quality management system in current scenario

“…It allows you to automatically track changes to SOPs, instructions, products, and product processes. Using the software, you can easily send changes through the approval process, and ensure that changes are implemented [6,9].…”

“…Whereas the preventive action is to abolish the source of a, potential nonconformity or other undesired possible outcomes. The CAPA can be effectively implemented to assure satisfactory quality and regulatory requirements by the following basic steps : [9,12].…”