Selection of API Vendors and the Impacts on Drug Products

This chapter discusses the necessity and significance of the selection of vendors and how the process will impact the quality and efficacy of the drug products manufactured by a company and consequently the pharmaceutical business. It presents an informed and comprehensive discussion on the primary and alternate active pharmaceutical ingredient (API) supplier selection processes for generic drug products manufacturing firms. The pharmaceutical industry is highly responsible for providing an enhancement to the health of society. The safety, efficacy, and quality of generic products are always comparable to the new drug products. A detailed manufacturing process including starting material, impurities, and residual solvents must be brought under review since it tends to affect all variables such as impurities, residual solvents, and physicochemical properties of API. Genotoxic impurities and metal impurities have also received extraordinary attention from not only the health authorities but also the industry.