To gain approval for marketing, a drugs sponsor(e.g a pharmaceutical company) must demonstrate, through supporting scientific evidence hat the new drug or drug product is safe and effective for its proposed use The sponsor must also demonstrate that the various processes and controls used in producing the drug substance and in manufacturing, packaging, and labeling are properly controlled and validated to ensure at the product meets established standardsTo gain approval for marketing, a drug’s sponsor (e.g., a pharmaceutical company) must demonstrate, through supporting scientific evidence, that the new drug or drug product is safe and effective for its proposed use. The sponsor must also demonstrate that the various processes and controls used in producing the drug substance and in manufacturing, packaging, and labeling are properly controlled and validated to ensure that the product meets established standards