Developing robust pharmaceutical production processes to ensure patient safety and drug efficacy is dependent on the sound understanding and control of the drug substance and drug product quality attributes relevant for clinical performance and drug product manufacture. This understanding is then translated into the design of the manufacturing process and a relevant monitoring and control system to ensure that quality attributes within the desired ranges are consistently obtained. This session covers both drug substance and drug product critical quality attribute identification, characterization, and monitoring systems for quality and manufacturing process control. Authors are encouraged to highlight clinically relevant specifications for pharmaceutical products and innovative control strategies for drug substance and drug product manufacturing.

Pharmaceutical Discovery, Development and Manufacturing Forum

Product Design (12G), Pharmaceuticals (15B)