Quality Target Product Profile
QTPP
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
A prospective summary of the quality characteristics a drug product should possess to ensure the desired safety and efficacy, considering the route of administration, dosage form, delivery system, container closure system, and strength — the foundational input from which critical quality attributes are derived in a Quality by Design approach.
The QTPP is established at the start of pharmaceutical development, before formulation work begins, and describes the product from the patient’s and prescriber’s perspective — for example a film-coated tablet, immediate release, for oral administration, with a defined dissolution profile and shelf-life target.
Once the QTPP is defined, development scientists identify which quality attributes are critical to achieving it (critical quality attributes) and which process parameters must be controlled to reliably deliver those attributes (critical process parameters) — the QTPP is therefore the anchor point the rest of the Quality by Design exercise traces back to.
A QTPP that is written too vaguely, or that omits a characteristic the patient population actually depends on — such as a specific delivery-device usability requirement — undermines the CQA and CPP work built on top of it later in development.
- —Established at the start of development, before formulation work
- —Describes the product from the patient/prescriber perspective, not internal process terms
- —The anchor input from which critical quality attributes are derived
- —Central to a Quality by Design development approach
ICH Q8(R2) Pharmaceutical Development, Annex
Frequently asked questions
What does Quality Target Product Profile stand for?
Quality Target Product Profile stands for QTPP.
What is Quality Target Product Profile?
A prospective summary of the quality characteristics a drug product should possess to ensure the desired safety and efficacy, considering the route of administration, dosage form, delivery system, container closure system, and strength — the foundational input from which critical quality attributes are derived in a Quality by Design approach.
Which regulations cover Quality Target Product Profile?
ICH Q8(R2) Pharmaceutical Development, Annex