ABSTRACT
In all cases, the product should be designed to meet patients’ needs and the intended product performance. Strategies for product development vary from company to company and from product to product. A greater understanding of the product and its manufacturing process can create a basis for more flexible regulatory approaches. The degree of regulatory flexibility is predicated on the level of relevant scientific knowledge provided in the registration application. It is the knowledge gained and submitted to the authorities, and not the volume of data collected, that forms the basis for science- and risk-based submissions and regulatory evaluations. Risk assessment is a valuable science-based process used in quality risk management that can aid in identifying which material attributes and process parameters have an effect on product critical quality attributes. While the risk assessment is typically performed early in the pharmaceutical development, it can be helpful to repeat the risk assessment as information and greater knowledge become available.
