This is a ready-to-use OOT investigation record. Replace every <<FILL: ...>> placeholder with your own specifics, and complete each section contemporaneously and signed. Sections marked “if applicable” are left N/A with a reason when not used. A worked filled specimen follows. Verify each cited regulation against the current source before you rely on it. This form is generated by the SOP: Out-of-Trend Detection and Investigation.
Record header
| Field | Entry |
|---|---|
| OOT record number | <<FILL: OOT-YYYY-nnn>> |
| Date opened | <<FILL: date>> |
| Initiated by | <<FILL: name / role>> |
| Product / material | <<FILL: product name, strength>> |
| Batch / lot | <<FILL: lot number>> |
| Study / trend source | <<FILL: stability study ID / CPV chart / EM location>> |
| Related documents | <<FILL: stability protocol, SOP, prior OOT>> |
Section 1: Flag capture
| Field | Entry |
|---|---|
| Attribute | <<FILL: assay, impurity, dissolution, potency, titer, count>> |
| Time point / condition | <<FILL: e.g. 12-month, 25C/60%RH>> |
| Result | <<FILL: value + units>> |
| Specification limit | <<FILL: registered/compendial range>> (in spec: Yes / No, if No route to OOS) |
| OOT limit and basis | <<FILL: e.g. prediction interval 97.2-99.2%, regression per protocol>> |
| Limit breached | Above / Below (alert / action, if graded) |
| Detection method | By-time-point / prediction interval / slope-control / control-chart run rule |
| Initial risk (ICH Q9) | Low / Medium / High and why: <<FILL>> |
Section 2: Data confirmation (before chasing a cause)
| Check | Outcome | Notes |
|---|---|---|
| Calculation / data entry | OK / Error found | <<FILL>> |
| Integration (chromatographic) | OK / Error / N/A | <<FILL>> |
| Transcription instrument to LIMS | OK / Error | <<FILL>> |
| System suitability at time of test | Pass / Fail | <<FILL>> |
| Instrument calibration status | In date / Out | <<FILL>> |
| Reference-standard lot / assigned value / expiry | OK / Changed | <<FILL: lot, value, whether it changed>> |
| Sample handling / chamber / condition | OK / Issue | <<FILL>> |
Assignable data error found? Yes / No. If yes, describe the correction under change control (original preserved), the recomputed value, and the reassessment against the OOT limit: <<FILL>>
Section 3: Context assessment
| Question | Finding |
|---|---|
| Isolated point or whole-batch trend? | <<FILL>> |
| Sister batches at same point/condition | <<FILL>> |
| Coherence across accelerated conditions | <<FILL>> |
| Common analyst / instrument / column / reagent | <<FILL>> |
| Known specified impurity behaving predictably, or unexpected peak (if impurity) | <<FILL: or N/A>> |
Likely nature: Laboratory cause / Sampling cause / Real product-process trend / Statistical noise. Rationale: <<FILL>>
Section 4: Laboratory assessment (if a lab cause is plausible and unresolved)
| Field | Entry |
|---|---|
| Analyst interview summary | <<FILL>> |
| Method / reagent / standard review | <<FILL>> |
| Retest performed | Yes / No / N/A |
| Pre-approved retest plan reference | <<FILL: plan ID; decision rule defined before execution>> |
| Retest outcome and interpretation | <<FILL>> |
Section 5: Root cause (if confirmed real)
| Field | Entry |
|---|---|
| Tool used | Fishbone / 5-Whys / Fault tree / Other |
| Root cause statement | <<FILL>> |
| Category | Formulation/excipient / Container-closure / Process shift / Inherent variability (model too tight) / Analytical drift |
Section 6: Impact and risk assessment
| Question | Assessment |
|---|---|
| Shelf life: regression re-run with new point; worst-case batch vs spec at expiry (ICH Q1E) | <<FILL: projected value at expiry, pass/fail>> |
| Other batches (market / campaign) affected | <<FILL>> |
| Specification or alert-limit change indicated | <<FILL>> |
| Patient / toxicological concern (e.g. impurity, nitrosamine) | <<FILL: or N/A>> |
Section 7: Disposition and CAPA
| Field | Entry |
|---|---|
| Batch disposition | <<FILL: released (in spec) / other>> with conditions: <<FILL: enhanced monitoring, shortened expiry, none>> |
| Deviation reference (if escalated) | <<FILL: number or N/A>> |
| CAPA reference and effectiveness-check date | <<FILL: number, date or N/A>> |
| Fed to PQR / management review | Yes / No, reference: <<FILL>> |
Section 8: Closure and approval
| Field | Entry |
|---|---|
| Conclusion | Confirmed trend / Assignable cause / Statistical noise |
| Investigator (name, signature, date) | <<FILL>> |
| QA disposition (name, signature, date) | <<FILL>> |
Acceptance criteria for a complete record
- The result was routed correctly (in spec, so OOT not OOS) and the OOT limit and basis are stated.
- Data confirmation was completed before any manufacturing cause was pursued, including the reference-standard lot check.
- Any retest ran under a pre-approved plan with a decision rule set in advance.
- A confirmed trend is linked to a shelf-life reassessment per ICH Q1E and to the PQR.
- QA, not the originating analyst alone, signs the disposition.
References
21 CFR 211.180(e), 211.192, 211.165(d). FDA OOS guidance (Rev. 1, May 2022) for the laboratory-assessment and no-testing-into-compliance principles. ICH Q1E (stability data evaluation and shelf life), ICH Q9(R1) (risk-based depth).
Confirm each reference against the current source before issue.
Filled specimen
Illustrative completed record for a stability assay OOT.
| Field | Entry |
|---|---|
| OOT record number | OOT-2026-0044 |
| Product / batch | Example mAb drug product 50 mg/mL / lot 26B0112 |
| Attribute / time point | Main-peak purity by SEC (%), 9-month, 5C |
| Result vs spec | 96.1%; spec not less than 95.0% (in spec) |
| OOT limit / basis | By-time-point action limit 96.8% (mean 98.0, wide provisional limit from 5 lots); below limit |
| Data confirmation | Integration and transcription sound; system suitability pass; standard lot unchanged; sample from correct chamber |
| Context | Whole-batch SEC trend steeper than peers; 25C accelerated coherent; no common analyst/column issue |
| Nature | Probable real product trend; Medium risk; DEV-2026-0288 opened |
| Root cause | Fill/finish hold time extended on this lot raised initial aggregate; normal slope reaches limit sooner |
| Shelf-life impact | Regression re-run; worst-case projects 95.4% at 24-month expiry, above 95.0. Shelf life retained, enhanced monitoring added |
| Disposition / CAPA | Released with enhanced monitoring; CAPA to cap hold time, effectiveness check month 26 |
| Closure | Confirmed trend; QA approved; fed to PQR |
Note the small-lot handling: with only five lots the limit is explicitly provisional and wide, the slope and accelerated coherence carry more weight than the single point, and the conclusion still connects to shelf life.
How to adapt this form
- Match the section fields to your LIMS and trending outputs so completion is a transcription, not a re-derivation.
- Point the retest, deviation, and CAPA references to your real procedures.
- For biologic and advanced-therapy products, keep the provisional-limit language visible so wide early limits are defensible.
- Confirm the references against current sources before issue.