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THE PHARMA REVIEW (JANUARY FEBRUARY 2015)

Embracing Quality by Design (QbD) in Pharmaceutical Industry

Fahad Hussain

Introduction: Quality by Design is a concept that was first outlined by a quality expert called Joseph M. Juran and was adopted by the U.S. Food and Drug Administration (FDA). This concept expressed suggestions that companies should build safety, quality and efficacy into their new pharmaceutical products as early as possible. In addition to this new concept being considered by FDA, two important guidance documents were published as part of International Conference on Harmonization (ICH) guidelines: Q8 Pharmaceutical Development and Q9 Quality Risk Management. 

 

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