Role Of Quality Control In Pharmaceutical Company.

[摘要] The pharmaceutical quality management system is a concept of management function that designand implement the “Quality policy”. The pharmaceutical manufacturing industries all over the world havejust begun to apply the United States Food and Drug Administration (USFDA) guidelines in the 21stcentury. The study tries to identify the quality metrics based on Quality Indicators for a pharmaceuticalindustry and to investigate the utilization of quality KPIs. Methodology: The work experience from asuccessfully working pharmaceutical organization related to Research and and Development (R&D) ofpharmaceutical products are discussed here. Important areas were identified and analysed based on thedata collected from the deviation reports of selected organization and other resources. The R&D centreuses a software system for Quality management system including, Deviation management, Changemanagement, Laboratory investigation, Incident management and Corrective Action and PreventiveAction (CAPA).

[学科分类] 工程和技术（综合）

[关键词] Quality;pharmaceutical company;world health organization;good manufacturing practices;foodand drug administration;quality risk management