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Quality metrics and quality kpi of pharmaceutical industry- a review of gap in existing practices

Author: 
Nirmal Kumar and Dr. AjeyaJha
Subject Area: 
Physical Sciences and Engineering
Abstract: 

Quality metrics are used throughout the pharmaceutical industry to monitor quality systems, processes and drive continuous improvement efforts in drug manufacturing. Quality Metrics (QM) are the refined and systematic representation of Quality- Key Performance Indicators (Q-KPI) during manufacturing operation. These can used to identify, where performance of quality management is good and meeting desired standards or where performance requires amendment. Objective: The purpose of this study is to identify the quality key performance indicators (KPI) and how comprehensively these are used during pharmaceutical manufacturing and distribution operations. Method: The exploratory method has been used for study through data available on regulatory websites and secondary data in articles of other researchers. Result: KPIs shall be enabler to describe the performances measures for Quality in pharmaceutical industry Conclusion: The Quality-KPI are used as tool to maintain quality of pharmaceutical products. It is important to identify and track KPI for Quality in pharmaceutical industry during manufacturing and distribution operations.

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