ABSTRACT: The current political environment, social climate, and economic challenges are creating enormous pricing pressures on the finished drug products marketed by the pharmaceutical industry regardless of branded formulation or a generic product.  These extraordinary pricing pressures are applying greater pressure on the profitability of finished drug products.  The need to maintain the profitability of the finished drug product is in turn driving the purchasing or sourcing strategy for lower cost active pharmaceutical ingredients (APIs) and excipients.  The drive for lower cost raw materials is creating the need to maintain a delicate balance between the Purchasing Strategy and the Quality Requirements during the supplier selection process.  The maintenance of the balance between the Purchasing Strategy and the Quality Requirements requires the use of quality risk management tools and a holistic approach to supplier qualification.

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