To design a quality product and its manufacturing process to consistently deliver the intended performance of the product (see ICH Q8); To enhance knowledge of product performance over a wide range of material attributes processing options and process parameters; To assess the critical attributes of raw materials, solvents, Active Pharmaceutical Ingredient (API) starting materials, APIs, excipients, or packaging materials; To establish appropriate specifications, identify critical process parameters and establish manufacturing controls To decrease variability of quality attributes: To assess the need for additional studies Make use of the “design space” concept.