The quality target product profile (QTPP) is an inherent part of product development and provides an overview of all the elements that have an impact on the quality, safety and efficacy of the product in a given clinical indication. The concept is defined in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guideline Q8 and may be more familiar for those developing conventional pharmaceuticals.
However, it also provides an excellent tool for advanced therapy medicinal product developers and should be used to consider all elements that have an impact on the ultimate quality of the product and, consequently, the safety and efficacy in clinical and commercial use. Building up the QTPP should start at the research phase and continue up to the marketing authorisation application (MAA) phase; if it is put together properly and regularly updated, it provides the skeleton for the entire chemistry, manufacturing and control module of the MAA.
The article is also featured in Regulatory Rapporteur – Vol 16, No 2, February 2019.