Manufacturers must prove that new drug products are free of cancer-causing impurities
Stephanie Sutton |
The US FDA has released a new guidance to help pharmaceutical manufacturers assess and control impurities that could cause DNA mutations in patients. Because of chemical synthesis or subsequent degradation, all drug products contain some impurities – guidance for the majority of impurities already exists but there hasn’t been a great deal to go on when it comes to DNA-reactive impurities. The new guidance aims to provide a “practical framework that is applicable to the identification, categorization, qualification, and control of these mutagenic impurities” (1). It establishes appropriate levels of impurities to minimize carcinogenic risk, and outlines recommendations for their assessment and control.
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