A Target Product Profile (TPP) is a strategic document that summarizes the intended clinical, regulatory, and commercial characteristics of a drug or biopharmaceutical product under development, serving as a roadmap that aligns research, development, manufacturing, and regulatory activities toward a common goal. It defines the target indication, patient population, route of administration, dosage form, efficacy endpoints, safety profile, and competitive differentiation, and is used to guide process development, analytical strategy, and regulatory submissions from early development through commercial launch. The TPP is closely related to — but distinct from — the Quality Target Product Profile (QTPP), which focuses specifically on product quality attributes.
