Regulatory agencies expect a robust impurity control strategy. The control strategy has a direct impact on drug safety, approval timelines, and lifecycle management. Therefore, chemistry graduates and regulatory professionals must understand how impurity control integrates into Drug Master File (DMF) submissions. Impurities arise from synthesis, degradation, or storage conditions. Even trace levels of impurities can affect safety and efficacy. Hence, regulatory agencies require detailed impurity identification, qualification, and control before approving any API.
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