Managing Raw Materials in the QbD Paradigm Part 2: Risk Assessment and Communication

ABSTRACT

Enhanced process and product understanding are the basic tenets of Quality by Design (QbD). Although significant advances have been made, appropriate characterization and management of raw materials remain a concern for the regulatory authorities. Because of the large number of raw materials that typically are used in biotech processes, a QbD-based approach for raw material management must be based on scientific knowledge and risk analysis. This strategy will ensure that adequate characterization is performed on those raw materials that have the most effect on process consistency and product quality. Part 1 of this article presented an approach for raw material management …