Abstract

Quality by design (QbD) is a scientific and risk-based approach to product development that begins at the product concept stage. This article will equip the excipient vendor with an understanding of QbD from the perspective of the topical pharmaceutical product manufacturer.

The US Food and Drug Administration (FDA) began an initiative in 2002 entitled Pharmaceutical Current Good Manufacturing Practices for the 21st Century – a Risk-Based Approach, which encouraged the pharmaceutical industry to adopt modern quality management techniques (1). As a participant in the International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals of Human Use (ICH), FDA contributed to a number of guidelines such as ICH Q4B (2), ICH Q8 (3), ICH Q9 (4), and ICH Q10 (5). These modern quality management techniques framed in terms of pharmaceutical regulatory concepts have been collectively called quality by design (QbD). QbD can be defined as a scientific, risk-based, holistic, and proactive approach to pharmaceutical product development. It begins at the product concept stage and is applied throughout development and into commercialization.

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