The Quality Target Product Profile or QTPP is a prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality, taking into account the safety and efficacy of the drug product.
The QTPP plays a critical role in the product lifecycle of any drug development program and forms the basis of design during product development activities. In many instances, this critical activity is usually not initiated until later in the drug development process even though early initiation can yield significant benefits.
A key early benefit is an alignment between stakeholders of the expectations around product performance.
Traditionally, the QTPP is a controlled document managed in a QMS.
We would argue, it should be a set of requirements managed digitally as it will evolve over time. Digital management allows for the straightforward integration of risk assessment and supporting justifications to facilitate greater transparency and collaboration.
In this video, you can learn more about how you can use QbDVision to digitally manage your QTPP within a validated, cloud-based software solution.
Contact us to get your digital journey started today.
