Batch BT-020062
Celdurin • CMO1 • L013 • completed
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
2025-02-22 → 2025-02-27
Actual
2025-02-09 → 2024-12-18
Exceptions
22
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|---|---|---|---|
| 001 Line Clearance Check | completed | 2026-09-01T03:38:00.000Z | 2025-11-29T18:45:00.000Z | - |
| 002 Dispensing Start | completed | 2026-04-27T18:45:00.000Z | 2025-07-21T00:47:00.000Z | Completed as per SOP |
| 003 API Weighing | in-progress | 2026-05-31T23:03:00.000Z | - | - |
| 004 Excipient Weighing | pending | - | - | - |
| 005 Granulation Start | exception | 2026-07-30T10:44:00.000Z | - | Value out of specification: undefined (spec: undefined-undefined) |
| 006 Granulation End Weight | completed | 2025-11-03T09:28:00.000Z | 2025-07-25T20:14:00.000Z | Completed as per SOP |
| 007 IPC - Loss on Drying | completed | 2026-06-09T20:13:00.000Z | 2026-02-12T09:09:00.000Z | - |
| 008 Blending Start | completed | 2025-09-27T15:13:00.000Z | 2025-11-24T03:59:00.000Z | Completed as per SOP |
| 009 Blending Time Verification | in-progress | 2026-09-18T16:22:00.000Z | - | - |
| 010 IPC - Blend Uniformity | pending | - | - | - |
| 011 Compression Setup | exception | 2025-04-23T23:49:00.000Z | - | Value out of specification: undefined (spec: undefined-undefined) |
| 012 IPC - Tablet Weight | completed | 2025-03-08T01:19:00.000Z | 2026-04-03T07:38:00.000Z | Completed as per SOP |
| 013 IPC - Tablet Hardness | completed | 2025-07-23T00:00:00.000Z | 2025-02-10T04:16:00.000Z | - |
| 014 IPC - Tablet Friability | completed | 2026-05-10T09:25:00.000Z | 2026-10-07T01:00:00.000Z | Completed as per SOP |
| 015 IPC - Tablet Dissolution | in-progress | 2026-09-16T08:47:00.000Z | - | - |
| 016 Film Coating Setup | pending | - | - | - |
| 017 IPC - Coating Weight Gain | exception | 2026-06-21T20:50:00.000Z | - | Value out of specification: undefined (spec: undefined-undefined) |
| 018 IPC - Tablet Appearance | completed | 2026-06-04T00:04:00.000Z | 2025-09-22T02:08:00.000Z | Completed as per SOP |
| 019 Filling Setup | completed | 2025-10-15T00:15:00.000Z | 2026-08-26T02:16:00.000Z | - |
| 020 IPC - Fill Weight Check | completed | 2025-03-01T18:33:00.000Z | 2026-07-11T12:34:00.000Z | Completed as per SOP |
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010620 | Water for Injection | in-process | Open workbench |
| LOT-010621 | Purified Water | approved | Open workbench |
| LOT-010622 | Ethanol 95% | approved | Open workbench |
| LOT-010623 | Isopropyl Alcohol | approved | Open workbench |
| LOT-010624 | Methylene Chloride | quarantine | Open workbench |
| LOT-010625 | Acetonitrile HPLC Grade | hold | Open workbench |
| LOT-010626 | Methanol HPLC Grade | rejected | Open workbench |
| LOT-010627 | Hydrochloric Acid 37% | expired | Open workbench |
| LOT-010628 | Sodium Hydroxide | consumed | Open workbench |
| LOT-010629 | Phosphoric Acid | in-process | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01034 Shrink Wrapper #35 | cleaning-required | 2026-05-15 | not-qualified |
| AST-01035 Checkweigher #36 | operational | 2025-03-01 | qualified |
| AST-01036 Metal Detector #37 | operational | 2025-11-20 | qualified |
| AST-01037 X-Ray Inspection #38 | operational | 2026-07-11 | qualified |
| AST-01038 Leak Tester #39 | in-calibration | 2025-02-05 | requalification-due |
| AST-01039 Torque Tester #40 | in-maintenance | 2025-10-05 | not-qualified |
| AST-01040 Granulator #41 | out-of-service | 2024-12-15 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|---|---|---|
| Line Clearance Check | 102 | 94 to 109 | Pass / Pending review |
| API Weighing | 99 | 97 to 104 | Pass / Pending review |
| IPC - Loss on Drying | 100 | 92 to 105 | Pass / Pending review |
| Blending Time Verification | 105 | 96 to 107 | Pass / Pending review |
| IPC - Tablet Hardness | 100 | 91 to 104 | Pass / Pending review |
| IPC - Tablet Dissolution | 100 | 97 to 105 | Pass / Pending review |
| Filling Setup | 102 | 90 to 105 | Pass / Pending review |
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Procedure Deviation | major | under-review | Not linked |
| Procedure Deviation | major | under-review | Not linked |
| Procedure Deviation | major | under-review | Not linked |
| Procedure Deviation | major | under-review | dev-00063 |
| Procedure Deviation | major | under-review | dev-01063 |
| Procedure Deviation | major | 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-020062
Score: 60
EBR completionComplete
Exceptions closedComplete
QC approvedComplete
Deviations dispositionedComplete
Calibration compliantComplete
Training confirmedComplete
Release review blocked - critical items outstanding.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.