The Quality Target Product Profile (QTPP) is a prospective summary of the quality characteristics of a drug substance or drug product that must be achieved to ensure the desired safety, efficacy, and patient experience. It defines the intended use, route of administration, dosage form, delivery system, dosage strength, and critical quality attributes (CQAs) that the product must meet, and serves as the scientific foundation for all process development, analytical development, and regulatory submission activities within a Quality by Design (QbD) framework in accordance with ICH Q8 guidelines.
