Product Quality Attribute Monitoring and Control in Drug Product Manufacturing

Robustness of drug product formulation and processing helps assure patient safety and drug efficacy being founded on thorough understanding and control. An understanding of the product requires knowledge of how the product performs in vivo, thus translating that knowledge of critical quality attributes that support efficacy and safety. This understanding is then translated into the drug product design and characterization of operating space. This session covers the drug product quality attribute identification, characterization, and related process/product monitoring and control strategy.