Impurities in Drug Products

, den 12. Oktober 2005

FDA’s Center for Drug Evaluation and Research (CDER) has revised a draft guidance from 1998 for Industry entitled ANDAs: Impurities in Drug Products that provides recommendations on what chemistry, manufacturing and controls (CMC) information sponsors should include regarding the reporting, identification, and qualification of impurities that are classified as degradation products in drug products when submitting abbreviated new drug applications (ANDAs) and ANDA supplements for changes that may affect the quantitative or qualitative degradation product profile. The guidance also gives recommendations for establishing acceptance criteria for degradation products in generic drug products.