Quality Target Product Profile (QTPP)

Categories: quality

Definition

Determining the QTPP is the first step in developing a product using Quality by Design (QbD) principles.
ICH Q8 (R2) defines this: “ A prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality, taking into account safety and efficacy of the drug product”. The QTPP is a starting point for determining the Critical Quality Attributes(CQAs) https://database.ich.org/sites/default/files/Q8%28R2%29%20Guideline.pdf