This article presents a practical view on QbD (Quality by Design) approach and its implementation. It is argued that, the critical component of the approach, the defined “quality” attribute to be achieved is lacking. To address this issue, from the consumer/patient perspective the quality of a tablet/capsule product may be defined as availability/release of the drug in an expected amount and manner. However, the technique most often used (known as drug dissolution testing) to evaluate such quality has been recognized to be flawed. Therefore, it is highly unlikely that the QbD approach as presented will be successful in providing improved quality of the products. Suggestions are made for addressing the issues for a potentially successful implementation of the QbD practice. Please click here for complete article
