This is a ready-to-use Quality Target Product Profile (QTPP) form. It is the anchor document a QbD program is built from: every Critical Quality Attribute, every risk assessment, and every downstream design-space claim should trace back to an element on this form. Replace every <<FILL: ...>> placeholder with your own specifics and route it through your normal document control, review, and approval. A worked filled specimen follows the template. Verify each cited regulation against the current source before you rely on it. This is general educational reference, not regulatory or professional advice; adapt it to your own product and quality system.
Document control header
| Field | Entry |
|---|---|
| Document title | Quality Target Product Profile (QTPP), <<FILL: product name>> |
| Document number | <<FILL: QTPP-ID, e.g. QTPP-2026-014>> |
| Version | <<FILL: version, e.g. 1.0>> |
| Effective date | <<FILL: effective date>> |
| Supersedes | <<FILL: prior version or "New">> |
| Product | <<FILL: product name, dosage form, strength(s)>> |
| Development stage at issue | <<FILL: e.g. pre-clinical, Phase 2, pre-BLA/NDA, commercial>> |
| Document owner | <<FILL: role, e.g. Head of Product Development>> |
1. Purpose
This form captures the Quality Target Product Profile, the planning concept ICH Q8(R2) introduced so a development program commits, in writing and ahead of manufacture, to the attributes a product has to show, chosen because they support the intended clinical benefit and a safe, effective outcome for the patient. It exists to give the development program one agreed, dated statement of what the product must be, so that every Critical Quality Attribute, every risk assessment, and every design-space claim that follows can be traced back to a documented basis instead of an unwritten assumption.
2. Scope
This form applies to the drug product (and, where relevant, the drug substance) named above, at the development stage stated in the header. It does not itself assign criticality; criticality is decided in a separate risk assessment once the QTPP elements are agreed. It does not replace the finished-product specification, which is a regulatory commitment set later and justified against, not copied from, this profile.
3. Instructions for completion
- Populate each applicable row of the field table in section 4 with a target, not a specification. A target states what the product should achieve (for example, a defined release profile); a specification is the tested acceptance range set later once process and analytical capability are understood. Conflating the two is the most common weakness in a QTPP.
- For every element, record the source or basis: literature, the reference listed drug’s label or characterization, the target patient population and route, clinical protocol requirements, applicable compendial general chapters, or platform/prior-product knowledge. An element with no stated basis is not traceable and will be challenged.
- Strike through, and state the reason for, any row that does not apply to this dosage form (for example, sterility for an oral solid, or a device-compatibility row for a product with no combination-product component).
- Route each element to the function best placed to set it (see section 5) before the form is finalized; a QTPP written entirely by one function tends to miss elements another function would have caught.
- Treat this as a living document. Revise it under change control when clinical, regulatory, or manufacturing understanding changes the target, and re-trace downstream CQAs and the design space when it does.
4. QTPP field table
| QTPP element | Target | Source / basis | Approved by |
|---|---|---|---|
| Intended use / indication | <<FILL>> | <<FILL: e.g. clinical protocol, label>> | <<FILL: role>> |
| Route of administration | <<FILL>> | <<FILL>> | <<FILL>> |
| Dosage form | <<FILL>> | <<FILL: e.g. reference product, formulation feasibility>> | <<FILL>> |
| Strength(s) | <<FILL>> | <<FILL: e.g. clinical dose-finding data>> | <<FILL>> |
| Container closure system | <<FILL>> | <<FILL: e.g. stability needs, patient handling, extractables/leachables risk>> | <<FILL>> |
| Pharmacokinetic target | <<FILL: e.g. bioequivalent to reference product; a defined release profile>> | <<FILL: e.g. reference product PK data>> | <<FILL>> |
| Identity | <<FILL>> | <<FILL: compendial or in-house method capability>> | <<FILL>> |
| Assay / potency | <<FILL: target range>> | <<FILL>> | <<FILL>> |
| Content or dose uniformity | <<FILL>> | <<FILL: relevant compendial uniformity chapter>> | <<FILL>> |
| Impurities / degradation products | <<FILL: qualified limits>> | <<FILL: ICH Q3A/Q3B, toxicology>> | <<FILL>> |
| Dissolution or release profile | <<FILL: N/A if not applicable to dosage form>> | <<FILL>> | <<FILL>> |
| Sterility / microbial limits | <<FILL: N/A if not applicable>> | <<FILL: dosage form, route>> | <<FILL>> |
| Particulate matter | <<FILL: N/A if not applicable>> | <<FILL: route, e.g. parenteral>> | <<FILL>> |
| Appearance | <<FILL>> | <<FILL>> | <<FILL>> |
| Stability / shelf life | <<FILL: target shelf life and storage condition>> | <<FILL: platform stability history, ICH Q1A>> | <<FILL>> |
| Administration / user-related attributes | <<FILL: e.g. swallowability, reconstitution time, device compatibility for a combination product>> | <<FILL: human factors, patient population>> | <<FILL>> |
| Other product-specific attribute | <<FILL: e.g. biologics: aggregation, charge variants, glycosylation, potency assay result; add rows as needed>> | <<FILL>> | <<FILL>> |
Add rows for any element specific to the modality (for example, a biologic’s higher-order structure or a cell therapy’s chain-of-identity attributes) rather than forcing the product into a small-molecule template.
5. Who approves each element
| Function | Typical responsibility |
|---|---|
| Clinical / medical | Confirms the pharmacokinetic target, dose, and any safety-driven limit. |
| Regulatory affairs | Confirms the intended use, indication wording, and any label-driven attribute. |
| Product development / formulation | Sets the dosage form, strength, container closure, and administration attributes; confirms technical feasibility. |
| Analytical development | Confirms every quality attribute named can actually be measured with an available or developable method. |
| Quality Assurance | Approves the completed QTPP and confirms it is traceable to source and ready to drive CQA identification. |
6. Retention
Retain the QTPP and every superseded version for the life of the product plus not less than <<FILL: retention period, e.g. the site records retention schedule, commonly 2 years past product discontinuation or per applicable regulation>>, since it is the documented basis a reviewer or inspector may ask to see traced forward to the finished-product specification at any point in the product’s life.
References
ICH Q8(R2), Pharmaceutical Development (defines the QTPP and its role as the basis of design). ICH Q11, Development and Manufacture of Drug Substances (extends the same logic to the drug substance). ICH Q6A / Q6B, Specifications (the finished-product and biotechnological/biological specification the QTPP is later traced into).
Confirm the current version of each reference before issue.
Revision history
| Version | Date | Author | Summary of change |
|---|---|---|---|
<<FILL: 1.0>> | <<FILL: date>> | <<FILL: author>> | Initial issue. |
Approvals
| Role | Name | Signature | Date |
|---|---|---|---|
| Author | <<FILL>> | ||
| Reviewer (Regulatory Affairs) | <<FILL>> | ||
| Approver (Quality Assurance) | <<FILL>> |
Filled specimen
The following shows the form completed for an illustrative 50 mg immediate-release film-coated tablet, chronic once-daily oral use, at the pre-BLA/NDA development stage. Numbers and sources are illustrative; replace them with your own.
| QTPP element | Target | Source / basis | Approved by |
|---|---|---|---|
| Intended use / indication | Chronic oral therapy, once-daily dosing | Clinical protocol CP-2026-04 | J. Alvarez, Clinical |
| Route of administration | Oral | Clinical protocol | J. Alvarez, Clinical |
| Dosage form | Immediate-release film-coated tablet | Formulation feasibility, reference product | R. Chen, Formulation |
| Strength(s) | 50 mg | Phase 2 dose-finding data | J. Alvarez, Clinical |
| Container closure system | HDPE bottle with induction seal; blister alternative | Stability program, patient handling assessment | R. Chen, Formulation |
| Pharmacokinetic target | Bioequivalent to reference listed drug, immediate release | Reference product label and PK study | J. Alvarez, Clinical |
| Identity | Positive by specific method | Compendial method feasibility | L. Osei, Analytical |
| Assay / potency | 95.0 to 105.0 percent of label claim | Platform history for this dosage form | L. Osei, Analytical |
| Content uniformity | Meets the relevant compendial uniformity-of-dosage-units chapter | Compendial requirement | L. Osei, Analytical |
| Impurities / degradation products | Each within ICH Q3B qualified limits | Toxicology qualification | L. Osei, Analytical |
| Dissolution | Not less than 80 percent (Q) in 30 minutes | Reference product dissolution profile | L. Osei, Analytical |
| Sterility / microbial limits | Not applicable (oral solid, non-sterile route) | Dosage form and route | R. Chen, Formulation |
| Particulate matter | Not applicable (oral solid) | Dosage form and route | R. Chen, Formulation |
| Appearance | White to off-white tablet, no visible defects | Formulation feasibility | R. Chen, Formulation |
| Stability / shelf life | 24 months at 25 C / 60 percent RH | Platform stability history, ICH Q1A | R. Chen, Formulation |
| Administration / user-related attributes | Swallowable tablet size for the target adult population | Human factors input | J. Alvarez, Clinical |
QA approval: M. Okonkwo, Quality Assurance, 03 September 2026.
Common inspection findings this form prevents
- A CQA list that appears without any documented QTPP behind it, so the criticality rationale cannot be traced to a patient-focused basis.
- A QTPP element stated as a finished-product specification rather than a target, so the specification looks self-justifying rather than derived.
- A QTPP with no recorded source or basis for an element, leaving a reviewer to ask where the number came from.
- A QTPP frozen at an early development stage and never revisited as clinical or manufacturing understanding matures.
- Elements approved by only one function, missing input a clinical, regulatory, or analytical reviewer would have raised.
How to adapt this form
- Set your document number, product, and development stage in the header.
- Add or strike rows in section 4 to match the actual dosage form and modality; a biologic, a combination product, or a cell or gene therapy will need attribute rows this generic table does not carry by default.
- Confirm the approving function in section 5 matches how your organization actually assigns ownership for each attribute type.
- Set your real retention period in section 6 from your records retention schedule.
- Once the QTPP is approved, use it as the direct input to the CQA/CPP/CMA criticality ranking risk assessment and reference it from the QbD development and control strategy summary report.