Quality by Design and Analytical Quality by Design for Pharmaceutical Development

Quality Target Product Profile (QTPP) is a concept that describes all the quality attributes (QA) of the product that can be optimized during the product development. Quality Control (QC) allows to assess the quality of the final product by means of the monitoring of the QAs and thus it is a key factor in pharmaceutical and biopharmaceutical development, since it assures safety and efficacy. Starting from the QTPP one or more analytical procedures (AP) have to be set up. Each AP has to be developed according to the quality attribute that has to be checked and this is defined in the Analytical Target Profile (ATP). The presentation will cover the application of Analytical Quality by Design (AQbD) principles and Design of Experiments (DoE) to AP development. The flowchart for AQbD adoption will be discussed, highlighting how DoE allows risk evaluation and mitigation. The presentation will point out the benefits of encouraging the use of DoE and other lifecyle tools to assist in achieving scientific goals, to have greater confidence in the data quality and decisions to be made based on the results obtained with the procedures.