Out-of-specification (OOS) results in pharmaceutical analysis require thorough investigation to identify root causes, which may include analytical errors or manufacturing issues. Regulatory guidelines outline the necessary steps for addressing OOS results and implementing corrective actions to ensure product quality.
Active pharmaceutical ingredients (APIs) can be compromised by impurities that affect product quality and safety. This article discusses types of impurities, their sources, detection methods, and strategies for mitigation during drug development.
Stability testing is crucial in pharmaceutical development to prevent degradation and harmful byproducts. The article discusses causes of instability, optimization strategies, packaging solutions, and advanced techniques to address these challenges effectively.