Batch BT-020377
Eptiveron • DRH • L028 • on-hold
About this view
This batch detail page ties execution evidence, material genealogy, equipment fitness, in-process controls, and quality events into one release-focused view. Users can trace each unit operation against timestamps and investigate linked exceptions without leaving context. The panelized layout supports QA review by exception while preserving full evidence access. Next actions include closing residual issues and completing disposition-ready evidence checks.
Planned
2024-08-11 → 2024-08-15
Actual
2025-04-23 → In progress
Exceptions
12
Release Risk
critical
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010016 | Sucrose | consumed | Open workbench |
| LOT-010017 | Trehalose | in-process | Open workbench |
| LOT-010018 | Histidine Buffer | approved | Open workbench |
| LOT-010019 | Sodium Chloride | approved | Open workbench |
| LOT-010020 | Water for Injection | approved | Open workbench |
| LOT-010021 | Purified Water | quarantine | Open workbench |
| LOT-010022 | Ethanol 95% | hold | Open workbench |
| LOT-010023 | Isopropyl Alcohol | rejected | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01216 Hardness Tester #217 | cleaning-required | 2026-06-17 | qualified |
| AST-01217 Friability Tester #218 | operational | 2025-08-10 | qualified |
| AST-01218 Particle Size Analyzer #219 | operational | 2025-11-01 | requalification-due |
| AST-01219 Microscope #220 | operational | 2024-12-13 | not-qualified |
| AST-01220 Laminar Flow Cabinet #221 | in-calibration | 2026-04-02 | qualified |
| AST-01221 Isolator #222 | in-maintenance | 2025-09-02 | qualified |
| AST-01222 WFI Still #223 | out-of-service | 2026-05-11 | qualified |
| AST-01223 RO System #224 | cleaning-required | 2025-07-31 | requalification-due |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Missing Signature | minor | under-review | Not linked |
| Missing Signature | minor | under-review | dev-01378 |
| Missing Signature | minor | under-review | Not linked |
| Missing Signature | minor | under-review | Not linked |
| Missing Signature | minor | under-review | Not linked |
| Missing Signature | minor | under-review | Not linked |
QA Review Checklist and Signatures
- Step execution completeness verified with signed evidence.
- All high-severity exceptions dispositioned or justified.
- QC release tests reviewed and OOS investigations closed or dispositioned.
- Final release signatory validated with segregation-of-duties check.
Release Readiness: BT-020377
Score: 95
EBR completionComplete
Exceptions closedComplete
QC approvedComplete
Deviations dispositionedComplete
Calibration compliantComplete
Training confirmedComplete
Release review complete - all criteria met.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.