Quality and lifecycle management
The aim of pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product. Critical formulation attributes and process parameters are generally identified through an assessment of the extent to which their variation can have an impact on the quality of the drug product. The physicochemical and biological properties of the drug substance that can influence the performance of the drug product and its manufacturability, or were specifically designed into the drug substance, should be identified and discussed. The excipients chosen, their concentration, and the characteristics that can influence the drug product performance or manufacturability should be discussed relative to the respective function of each excipient. Risk assessment is a valuable science-based process used in quality risk management that can aid in identifying which material attributes and process parameters potentially have an effect on product critical quality attributes.