Structuring the Quality Assurance Function

Abstract

With the importance of producing quality products and processes, and the increase in regulatory scrutiny of all aspects of the pharmaceutical product development and manufacturing cycle, companies across the industry are examining their approaches to managing quality. This study was aimed at understanding how some of the leading firms in the industry structure their quality assurance (QA) functions to meet the current challenges and to identify structural characteristics that were common for success.Companies appear to be centralizing the management of QA functions on a global basis, and the preferred organizational approach for these global organizations is to combine the Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and Good Manufacturing Practices (GMP) functions. More often than not, if all three groups are combined, they report into research and development (R&D) management. Three criteria emerge as the critical success factors to consider when organizing QA functions: impact, indep...