This is a ready-to-use system suitability test (SST) form. It does two jobs: it fixes the SST parameters and their acceptance limits for a method (the specification), and it records the SST result at each use so a reviewer can see the run was valid before any sample result is trusted (the run record). SST is a gate, not a result: samples acquired under a failing SST are not reported. Replace every <<FILL: ...>> placeholder, set your document numbers and dates, and route through your normal document control. A filled specimen follows. Confirm each cited regulation and chapter against the current source before you rely on it.
Form control header
| Field | Entry |
|---|---|
| Form title | System Suitability Test Criteria and Run Record |
| Form number | <<FILL: FORM-ID, e.g. FORM-QC-058>> |
| Version | <<FILL: version, e.g. 1.0>> |
| Effective date | <<FILL: date>> |
| Method / procedure | <<FILL: method ID and version, e.g. TM-1042 v3>> |
| Governing SOP | <<FILL: SOP-ID for chromatographic analysis>> |
1. Why SST exists
A method can be fully validated and still produce unreliable results on a given day because the column aged, a mobile phase was mis-mixed, the injector drifted, or a standard was mis-prepared. The SST is the check that the whole system, the instrument, column, reagents, standards, and analyst, is performing well enough at the moment of use. It runs before any sample and is re-confirmed through the sequence by bracketing standards. If SST fails, the run is invalid for a system reason; you investigate the system, correct it, and restart, and you do not report or trend the failing data as analyte results. ICH Q2(R2) treats SST as integral to the procedure and USP General Chapter <621> Chromatography defines the standard parameters and their default expectations.
2. SST specification (set per method)
Fill in the acceptance limit for each parameter your method requires. Leave a row marked “not applicable” where the parameter does not apply to your detection or method type, and add impurity-method rows (signal-to-noise at the reporting threshold, resolution to the closest impurity) where relevant.
| # | Parameter | What it controls | Acceptance limit (set per method) | Applies |
|---|---|---|---|---|
| S-1 | Replicate injection precision (%RSD of peak area) | Injector and overall system repeatability | <<FILL: e.g. not more than 2.0 percent for 5 or 6 injections>> | Yes / No |
| S-2 | Resolution (Rs) between the critical pair | Separation of the analyte from the nearest peak | <<FILL: e.g. not less than 2.0>> | Yes / No |
| S-3 | Tailing factor (T) | Peak symmetry and integration reliability | <<FILL: e.g. not more than 2.0>> | Yes / No |
| S-4 | Theoretical plates (N) | Column efficiency | <<FILL: e.g. not less than 2000>> | Yes / No |
| S-5 | Retention time / capacity factor window | Analyte elutes where expected | <<FILL: e.g. within defined window>> | Yes / No |
| S-6 | Standard check / working-vs-reference agreement | Standard preparation is correct | <<FILL: e.g. 98.0 to 102.0 percent>> | Yes / No |
| S-7 | Signal-to-noise at reporting threshold (impurity methods) | Sensitivity for small peaks | <<FILL: e.g. not less than 10:1>> | Yes / No |
Bracketing and frequency
- Number of SST injections at the start:
<<FILL: e.g. 6>> - Re-confirmation frequency through the sequence:
<<FILL: e.g. one bracketing standard every 6 to 10 samples and at the end>> - Rule if a bracketing standard fails mid-sequence:
<<FILL: every sample bracketed by the failing standard is invalidated and re-injected>>
3. Decision sequence
- Equilibrate the system and confirm a stable baseline.
- Inject the SST standard the required number of times.
- Evaluate every applicable parameter against its limit before injecting any sample.
- If SST passes, proceed, and re-confirm at the defined frequency.
- If SST fails, stop. Do not inject samples. Investigate the system cause, correct it, restart the sequence. Record the SST failure as a system event, not an out-of-specification result.
4. SST run record (complete at each use)
| Field | Entry |
|---|---|
| Sequence / run ID | <<FILL>> |
| Instrument ID | <<FILL>> |
| Column ID / lot / serial | <<FILL>> |
| Mobile phase lot(s) | <<FILL>> |
| Standard ID / lot / potency | <<FILL>> |
| Date / analyst | <<FILL>> |
| Parameter | Limit | Result | Pass/Fail |
|---|---|---|---|
| Replicate precision (%RSD) | <<FILL>> | <<FILL>> | <<FILL>> |
| Resolution (Rs) | <<FILL>> | <<FILL>> | <<FILL>> |
| Tailing factor (T) | <<FILL>> | <<FILL>> | <<FILL>> |
| Theoretical plates (N) | <<FILL>> | <<FILL>> | <<FILL>> |
| Other (S-5 to S-7) | <<FILL>> | <<FILL>> | <<FILL>> |
| Overall SST | Pass required to proceed | <<FILL>> | <<FILL>> |
| Reviewed by / date | <<FILL>> |
5. Acceptance criteria
- Every applicable SST parameter meets its pre-set limit before any sample is injected.
- Bracketing standards through the sequence continue to meet the limits; any failing bracket invalidates the samples it brackets.
- The SST record is complete, attributable, and reviewed, and ties to the sequence in the data system audit trail.
6. References
ICH Q2(R2), Validation of Analytical Procedures (system suitability integral to the procedure). USP General Chapter <621>, Chromatography (system suitability parameters and defaults). 21 CFR 211.160(b) (scientifically sound laboratory controls) and 211.194 (laboratory records).
Confirm the current version and clause numbers of each reference before issue.
7. Revision history
| Version | Date | Author | Summary of change |
|---|---|---|---|
<<FILL: 1.0>> | <<FILL: date>> | <<FILL: author>> | Initial issue. |
Filled specimen
The following shows the run record completed for an illustrative reversed-phase HPLC assay. Numbers are illustrative.
Method: TM-1042 v3. Sequence: SEQ-2607-118. Instrument: HPLC-07. Column: C18, 150 x 4.6 mm, lot 22C-441. Standard: RS-2208, potency 99.4 percent. Analyst: A. Rahman, 21-Jul-2026.
| Parameter | Limit | Result | Pass/Fail |
|---|---|---|---|
| Replicate precision (%RSD, 6 inj) | not more than 2.0 percent | 0.4 percent | Pass |
| Resolution (Rs, critical pair) | not less than 2.0 | 2.8 | Pass |
| Tailing factor (T) | not more than 2.0 | 1.2 | Pass |
| Theoretical plates (N) | not less than 2000 | 8,410 | Pass |
| Retention time window | 6.5 to 7.5 min | 7.0 min | Pass |
| Overall SST | Pass required to proceed | Pass | Pass |
| Reviewed by / date | R. Gomez, 22-Jul-2026 |
A bracketing standard injected after sample 8 gave %RSD 0.5 percent and Rs 2.7, still within limits, so all bracketed samples remained valid. Had that bracket read Rs 1.6, samples 1 through 8 would have been invalidated and re-injected after the system cause was found and corrected.
Common inspection findings this form prevents
- Sample results reported under a failing or absent SST.
- SST parameters not defined for the method, or “adjusted” after a poor result (a data integrity finding, the same class as loosening any acceptance criterion).
- Bracketing standards not run, so a mid-sequence drift is never caught.
- An SST failure worked up as an out-of-specification investigation instead of a system event.
- Cherry-picking which SST injections count toward the %RSD.
How to adapt this form
- Set the applicable parameters and their limits in section 2 from your method and USP <621>; mark non-applicable rows clearly.
- Define the bracketing frequency and the mid-sequence failure rule to match your data system’s sequence design.
- For impurity methods, add the signal-to-noise and closest-impurity resolution rows.
- Tie the record to your chromatography data system so the SST is a real gate in the sequence, not a paper afterthought. See chromatography-data-system-integrity.
- Confirm every regulation and chapter in section 6 against the current published version before issue.