This is a ready-to-use Analytical Target Profile (ATP) form. Under ICH Q14, the ATP is the anchor document an enhanced analytical development effort is built from: it states the performance the method must deliver, independent of the technique that will eventually deliver it, so every downstream risk assessment, proven acceptable range, and validation criterion can be traced to a documented requirement instead of a number that “has always been that.” 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 | Analytical Target Profile, <<FILL: method/analyte name>> |
| Document number | <<FILL: ATP-ID, e.g. ATP-2026-011>> |
| Version | <<FILL: version, e.g. 1.0>> |
| Effective date | <<FILL: effective date>> |
| Supersedes | <<FILL: prior version or "New">> |
| Product and method purpose | <<FILL: product name; e.g. release assay, impurity method, potency bioassay>> |
| Development stage at issue | <<FILL: e.g. early development, pre-validation, post-approval change>> |
| Document owner | <<FILL: role, e.g. Analytical Development Lead>> |
1. Purpose
This form captures the Analytical Target Profile, the prospective, technique-independent statement of what an analytical procedure must deliver so that a candidate method can be judged against a documented requirement rather than against whatever the first working procedure happened to produce. It exists so every analytical procedure attribute, risk assessment, proven acceptable range, method operable design region (MODR), and validation acceptance criterion that follows can be traced back to an agreed, dated performance target.
2. Scope
This form applies to the analytical procedure named above, at the development stage stated in the header. It does not itself name a technique, a column, an instrument, or a wavelength; those are properties of the solution chosen during development, not of the requirement. It does not replace the validation protocol, which demonstrates that a specific chosen procedure meets the targets set here.
3. Instructions for completion
- State the quantity being measured and the reportable range in terms of the relevant specification or decision, not in terms of an instrument response.
- State accuracy and precision as a single, combined performance target (a target measurement uncertainty or equivalent combined criterion) wherever the organization’s statistical approach supports it, rather than as two independently set, loosely connected limits.
- State specificity as a functional requirement (what the method must distinguish the analyte from), not as a chromatographic condition.
- Record the decision the result supports. This is what ultimately sets how tight the performance needs to be, and it is the first thing a reviewer or inspector will ask you to justify.
- Record the source or basis for each numeric target: the governing specification, a stability or shelf-life claim, a compendial reporting/identification/qualification threshold (for an impurity method, ICH Q3A/Q3B), or a decision-risk calculation. A target with no stated basis is not defensible.
- Route each element to the function best placed to set it (section 5) before the form is finalized.
- Treat this as a living document. Revise it under change control if the specification, the decision the method supports, or the risk tolerance changes, and re-evaluate whether the currently validated procedure still meets the revised target.
4. ATP field table
| ATP element | Target | Source / basis | Approved by |
|---|---|---|---|
| Purpose of the method | <<FILL: e.g. batch release, stability, in-process control, cleaning verification>> | <<FILL>> | <<FILL: role>> |
| Analyte(s) and matrix | <<FILL: analyte, product/matrix, known degradants or related substances>> | <<FILL>> | <<FILL>> |
| Reportable range | <<FILL: e.g. 70-130% of label claim; or reporting/identification/qualification thresholds for an impurity method>> | <<FILL: specification, ICH Q3A/Q3B, stability extremes>> | <<FILL>> |
| Accuracy and precision (combined performance target) | <<FILL: e.g. reported result within +/- X% of true value with not less than Y% probability across the reportable range>> | <<FILL: specification width and acceptable decision risk>> | <<FILL>> |
| Specificity | <<FILL: e.g. baseline-level separation from named degradants/impurities and excipients; peak purity confirmed>> | <<FILL: known degradation pathway, forced-degradation knowledge, process-related impurities>> | <<FILL>> |
| Detection / quantitation limit (if applicable) | <<FILL: N/A if not applicable to method purpose>> | <<FILL: compendial or toxicological threshold>> | <<FILL>> |
| Robustness expectation | <<FILL: e.g. method must tolerate normal day-to-day variation in the parameters expected to be studied>> | <<FILL>> | <<FILL>> |
| Decision the result supports | <<FILL: e.g. pass/fail batch disposition; stability trend; in-process go/no-go>> | <<FILL>> | <<FILL>> |
| Modality-specific attribute (if applicable) | <<FILL: e.g. relative potency and parallelism criterion for a bioassay; calibration-model performance for a chemometric method; add rows as needed>> | <<FILL>> | <<FILL>> |
Add rows for any element specific to the method class (for example, a chemometric method’s calibration-model performance requirement, or a bioassay’s parallelism and relative-potency confidence-interval requirement) rather than forcing every method into a chromatographic template.
5. Who approves each element
| Function | Typical responsibility |
|---|---|
| Analytical development | Drafts the ATP, confirms the targets are technically achievable, and owns the document through development. |
| Quality Assurance | Approves the ATP and confirms every element traces to a documented basis before development work relies on it. |
| Statistician (where available) | Confirms the combined accuracy/precision target and the underlying decision-risk calculation are statistically sound. |
| Regulatory affairs | Confirms the target aligns with any commitment already made in a filing (for example, a specification or reporting threshold). |
| Method owner (post-transfer) | Confirms the ATP still applies at the receiving site and flags if local requirements (compendial, regional) demand an addition. |
6. Retention
Retain the ATP and every superseded version for the life of the method plus not less than <<FILL: retention period, e.g. the site records retention schedule>>, since it is the stable reference point a reviewer or inspector will ask to see every subsequent method change, transfer, and validation traced back to.
References
ICH Q14, Analytical Procedure Development (defines the ATP and its role as the basis of enhanced development). ICH Q2(R2), Validation of Analytical Procedures (the validation deliverable that demonstrates the chosen procedure meets the ATP). ICH Q9(R1), Quality Risk Management (the risk tools used to translate the ATP into ranked development priorities).
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 (Statistician or Analytical Development) | <<FILL>> | ||
| Approver (Quality Assurance) | <<FILL>> |
Filled specimen
The following shows the form completed for an illustrative finished-product assay of a film-coated oral tablet, at the pre-validation development stage. Numbers and sources are illustrative; replace them with your own.
| ATP element | Target | Source / basis | Approved by |
|---|---|---|---|
| Purpose of the method | Batch release and stability assay | Product specification | L. Osei, Analytical Development |
| Analyte(s) and matrix | Drug substance X in a film-coated tablet, in presence of excipients and known degradants D1-D3 | Formulation and forced-degradation knowledge | L. Osei, Analytical Development |
| Reportable range | 70-130% of label claim | Release specification (95.0-105.0%) plus stability extremes | L. Osei, Analytical Development |
| Accuracy and precision (combined) | Reported result within +/- 2.0% of true value with not less than 95% probability across the reportable range | 10% specification window; low false-OOS risk target | S. Nakamura, Statistician |
| Specificity | Baseline-level separation of analyte from D1-D3 and all excipient peaks; peak purity confirmed | Known degradation pathway and process-related impurities | L. Osei, Analytical Development |
| Detection / quantitation limit | N/A (assay method, not an impurity method) | Method purpose | L. Osei, Analytical Development |
| Robustness expectation | Method must tolerate normal day-to-day variation in mobile-phase pH, column temperature, and gradient slope without losing critical-pair resolution | Anticipated routine operating variation | L. Osei, Analytical Development |
| Decision the result supports | Pass/fail batch disposition against 95.0-105.0% specification; stability trend | Product specification and stability program | M. Okonkwo, Quality Assurance |
QA approval: M. Okonkwo, Quality Assurance, 10 September 2026.
Common inspection findings this form prevents
- Validation acceptance criteria that appear with no documented rationale, because no ATP was written before development started.
- An accuracy and precision target set after the method was already built, so the “requirement” simply restates what the method happened to achieve.
- A specificity requirement copied from a template method rather than derived from the analyte’s actual known degradants and process-related impurities.
- A method change evaluated against “does it look similar” instead of “does it still meet the documented target,” because no stable, technique-independent reference point exists.
- A biologic or multivariate method forced into a chromatographic ATP structure, losing the parallelism, relative-potency, or calibration-model requirement that method class actually needs.
How to adapt this form
- Set your document number, method, and development stage in the header.
- Add or strike rows in section 4 to match the actual method class; a chemometric or biological method 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 analytical development decisions.
- Set your real retention period in section 6 from your records retention schedule.
- Once the ATP is approved, use it as the direct input to the analytical procedure development report and the proven acceptable range / MODR change evaluation risk assessment.