Supplier Quality Management: Monitoring the Quality and Compliance of API Suppliers, Defining Generic Pharma as the Customer

This thesis presents the theory of applying a detailed internal company system, Supplier Quality Management (SQM), which not only establishes, but monitors the quality and compliance of Active Pharmaceutical Ingredient (API) suppliers under the appropriate regulations and guidances. The Generic Pharmaceutical Industry is defined as the customer. The product is defined as the finished pharmaceutical drug product for use by the consumer.