Page 1 of 42 Quality by Design Specifications for Solid Oral Dosage Forms: Multivariate Product and Process Monitoring for Managing Drug Quality Attributes by the Specification Design and Lifecycle Management Working Group of the PQRI Manufacturing Technical Committee Preamble

The purpose of this paper is to stimulate discussion around the thought processes and activities that occur from creation through development and commercialization of a molecule that ultimately becomes a drug product that benefits patients. This includes exploring the scientific evidence and pharmacological underpinnings that link clinical concepts to drug product design, manufacturing controls and specifications for active pharmaceutical ingredients (API), excipients and impurities that may be present. We have taken a “concept car” approach to facilitate dialog on setting clinically relevant specifications with Quality by Design (QbD) principles for a drug product.