(51d) A Regulators Perspective On the Evaluation and Control of Ingredient Quality

The compendial specifications are limited in their ability to define and quantify the quality of ingredients as it pertains to their functional performance in processes and products. The properties of materials will affect how they behave and the observed behavior can change dramatically as the scale of operation increases. A significant body of information about ingredient physicochemical properties gathered in early phase material characterization studies should be useful when entering the scale up phase of development. Better understanding of the interrelationships involving measurable ingredient properties can lead to better predictions of how the ingredients will behave as the process is scaled up, including how ingredient behavior will be influenced by process variables, equipment and environmental conditions. Manufacturers should find a body of knowledge and data pertaining to ingredients useful in their efforts to design more robust and predictable processes. Supplier management - including qualification, auditing and monitoring - will be discussed as tools that help build and maintain control over ingredient quality to promote reliable processing at scale-up and throughout the product lifecycle.