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 Quality Is Free 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.
|School:||California State University, Dominguez Hills|
|School Location:||United States -- California|
|Source:||MAI 55/03M(E), Masters Abstracts International|
|Keywords:||API, Cost of Quality, GMP, Plan-Do-Study-Act, QMS, Supply Chain|
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