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Estudios Gerenciales

Print version ISSN 0123-5923


GARCIA APONTE, Oscar Fabián; VALLEJO DIAZ, Bibiana Margarita  and  MORA HUERTAS, Claudia Elizabeth. Quality by design: Principles and opportunities for the pharmaceutical industry. estud.gerenc. [online]. 2015, vol.31, n.134, pp.68-78. ISSN 0123-5923.

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, based on a literature analysis, the noteworthiness of quality by design when products are being developed 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.

Keywords : Quality by design; Pharmaceutical industry; Quality management.

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