Quality by design offers advantages over previous quality assurance models, being useful in areas where quality means the differentiation and implementation of flexible processes to stimulate continuous improvement and innovation. As a contribution to making quality by design easier to implement in the Colombian pharmaceutical industry, this paper discusses why this concept was originated. Likewise, basedona literature analysis, thenoteworthiness of quality bydesignwhenproducts are beingdeveloped is discussed, and methodological strategies for its accomplishment are proposed. The reported evidence suggests that quality by design builds consumer, industrial and regulatory confidence on the quality of pharmaceutical products. © 2014 The Authors. Published by Elsevier Espana, S.L.U. on behalf of Universidad ICESI. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/3.0/). A qualidade desde o projecto: principios e oportunidades para a industria farmaceutica