Quality Target Product Profile

The Quality Target Product Profile (QTPP) is an essential document setting the stage for product development. The CMC organization cannot develop the right product if they don’t have a common understanding of what the design framework and target of the clinical product is. Ideally, you would like to start the clinical trials with a drug product which is maturation ready meaning that the product can be matured into a commercial product with only minor optimization and changes along the way. In real life this might not be possible as for instance if a vial formulation is used for first human dosing but a prefilled syringe combined with an injection device is desired for commercial launch. All these scenarios can be adressed in the QTPP so it is clear to the project team how the product will evolve on the long term.

Creating a QTPP is a great chance for CMC development and clinical operations to have a design talk and align expectations regarding the product presented for human testing. The QTPP document is established through workshops with the relevant experts providing input to the product design. If you don’t have a QTPP already then download the template from below, gather the team and get started today. The template covers both drug substance and drug product.