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White Paper

Quality by Design, Every Step of the Way

Introduction

One of the goals of QbD is to ensure that all sources of variability affecting a process are identified, explained, and managed by appropriate measures so that the finished medicine consistently meets its predefined characteristics from the start of development. The first element of QbD involves identifying the target product profile. This is a prospective summary of the quality characteristics of a drug product that will ideally be achieved to ensure the desired quality, while considering the safety and efficacy of that product.