(176b) The Concept of Qbd Applied to API Starting Materials

The concept and application of Quality by Design (QbD) principles has been, and will undoubtedly continue to be, an evolving topic in the pharmaceutical industry. In an effort to establish consensus and develop consistency, industry and regulators have frequently described QbD by dividing it into three fundamental, interrelated concepts; control strategy, design space, and criticality. This paper provides perspective of QbD applications for the assessment of criticality for starting materials (SM) used to manufacture API. Using a criticality decision tree, and examples from the torcetrapib manufacturing process, case studies for each SM's quality attributes (QA's) will be evaluated with proposed criticality assignments.