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Identification of pharmaceutical quality metrics: pharmaceutical industry

Author: 
Raghavendra, D. Dr. Chauhan, R.K. and Dr. Mallikarjuna Rao, T.D.
Subject Area: 
Health Sciences
Abstract: 

Quality metricsare essential metrics for any pharmaceutical industry and assuring customers/patients are provided with safety/identity/strength/purity/quality drug products with zero defect. Pharmaceutical quality metrics identification is complex, involving numerous metrics that influence the performance of a pharmaceutical quality system. Pharmaceutical quality metrics are paramount established Real-Time Governance and visualization of deteriorated quality trends to the senior management. Through this management shall draw action points/corrective & preventive actions to the painful areas/area of improvements/non-compliances.Quality metrics display of the department’s information which need to achieve one or more objectives; consolidated and arranged in a single frame so that the information can be monitored effectively by management at a glance. Objective: The purpose of this study is to identify the pharmaceutical quality metrics and bymonitoring the strategy of pharmaceutical industry which can check on department's activities in order to achieve service-level targets and operations. Methods: Interview with pharmaceutical industry employees has been used for primary source of data. And the exploratory method has been used for study through data available on regulatory websites and secondary data in articles of other researchers. Results: Total 68 quality metrics are determined as essential quality metrics for pharmaceutical industry. Conclusion: Through quality metrics visualizations pertaining to all departments can be monitored effectively & take necessary actions if needed and mitigate the quality risk .and achieve connect-communicate-collaborate with all stakeholders of organization.

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