CMC- Quality Target Product Profile

The Quality Target Product Profile (QTPP) is a foundational document in drug development that encapsulates all critical aspects required for the formulation of a new drug product. It should be collaboratively drafted by all stakeholders in the drug development chain, including R&D, manufacturing, marketing, and physicians. A well-constructed QTPP serves as a guiding framework for the development process, ensuring that all parties are aligned on the essential features and objectives of the drug product. Typically, a comprehensive QTPP will outline key elements such as the indication, route of administration, dosage form, required dose, primary container specifications, preferred storage conditions, and other considerations that facilitate patient compliance or market differentiation, such as tablet or capsule size and color.

At Tandem Biopharma CMC Consulting, we assist our clients in creating an effective QTPP that initiates drug product development with a comprehensive understanding of the target product profile. By establishing a clear and detailed QTPP at the outset, we help to minimize errors throughout the development process, ultimately reducing both the budget and timeline required to bring the product to market. This proactive approach ensures that all development decisions are made with the best knowledge of the target product in mind.