<p> Active Pharmaceutical Ingredient (API) repackagers play a niche, yet critical role in the expansive pharmaceuticals industry. Many repackagers have sub-optimally implemented quality management systems (QMS) leading to sub-optimal performance and elevated risks. This study sets out to demonstrate a strategy to strengthen the case for quality for this industry sector. Dr. Deming's Plan-Do-Study-Act cycle serves as the study's framework, while Phil Crosby's <i>Quality Is Free</i> philosophy forms the theoretical basis. An archival measure of FDA Warning Letters concerning APIs has been performed to bring a considerable failure cost factor to the forefront. A statistical analysis has been performed on data available from the study's pilot firm to demonstrate relationships between quality-related and revenue performance indicators in order to present a bottom-line approach preferred by management. Results from the study indicate a linkage between QMS factors and business outcomes and call for improved understanding, increased support, and a push towards QMS maturation.</p>
| Identifer | oai:union.ndltd.org:PROQUEST/oai:pqdtoai.proquest.com:10020158 |
| Date | 05 March 2016 |
| Creators | Wang, Alan |
| Publisher | California State University, Dominguez Hills |
| Source Sets | ProQuest.com |
| Language | English |
| Detected Language | English |
| Type | thesis |
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