Stage 1A Process Design: Quality by Design

Abstract

Quality by design (QbD) (US FDA, Quality by design for ANDAs: an example for immediate-release dosage forms, 2012) approach in product development has become a norm as Regulatory Agencies are basing their decisions on submitted product on the review of the scientific information generated and presented in a systematic way. It reduces the issues and burden at process validation stage and throughout the commercial manufacture. Consequently, it reduces the need for post approval changes driven by processing issues but also facilitates approval of process improvement changes that may fall within the originally studied design space.