Quality Target Product Profile

The first question any CMC employee should ask the development organization is where they can find the Quality Target Product Profile (QTPP). 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 off the clinical trials with a drug product which is maturation ready meaning that the product can be matured into a commercial product with minor tweaks and changes along the way (if you reach that far).

Creating a QTPP is a great chance for CMC development and clinical operations to have a technical talk on what the expectations and demands are for 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.