Batch BT-020063
Celdurin IV • CMO2 • L014 • 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
2024-05-05 → 2024-05-11
Actual
2026-08-09 → 2025-03-27
Exceptions
5
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|---|---|---|---|
| 001 Line Clearance Check | completed | 2026-12-10T08:38:00.000Z | 2025-06-06T16:15:00.000Z | - |
| 002 Dispensing Start | completed | 2025-09-15T17:00:00.000Z | 2025-10-14T09:02:00.000Z | Completed as per SOP |
| 003 API Weighing | in-progress | 2026-05-17T18:19:00.000Z | - | - |
| 004 Excipient Weighing | pending | - | - | - |
| 005 Granulation Start | exception | 2026-08-20T02:44:00.000Z | - | Value out of specification: undefined (spec: undefined-undefined) |
| 006 Granulation End Weight | completed | 2026-11-11T06:16:00.000Z | 2026-03-31T07:47:00.000Z | Completed as per SOP |
| 007 IPC - Loss on Drying | completed | 2026-10-29T10:33:00.000Z | 2025-04-13T00:08:00.000Z | - |
| 008 Blending Start | completed | 2026-02-07T11:24:00.000Z | 2026-03-17T08:48:00.000Z | Completed as per SOP |
| 009 Blending Time Verification | in-progress | 2025-08-02T10:20:00.000Z | - | - |
| 010 IPC - Blend Uniformity | pending | - | - | - |
| 011 Compression Setup | exception | 2026-06-16T19:41:00.000Z | - | Value out of specification: undefined (spec: undefined-undefined) |
| 012 IPC - Tablet Weight | completed | 2025-03-27T05:17:00.000Z | 2026-01-14T17:33:00.000Z | Completed as per SOP |
| 013 IPC - Tablet Hardness | completed | 2026-12-16T12:45:00.000Z | 2025-08-11T10:54:00.000Z | - |
| 014 IPC - Tablet Friability | completed | 2026-02-03T21:01:00.000Z | 2026-06-24T05:40:00.000Z | Completed as per SOP |
| 015 IPC - Tablet Dissolution | in-progress | 2026-06-02T19:07:00.000Z | - | - |
| 016 Film Coating Setup | pending | - | - | - |
| 017 IPC - Coating Weight Gain | exception | 2026-07-02T06:07:00.000Z | - | Value out of specification: undefined (spec: undefined-undefined) |
| 018 IPC - Tablet Appearance | completed | 2025-02-12T21:14:00.000Z | 2025-10-04T07:51:00.000Z | Completed as per SOP |
| 019 Filling Setup | completed | 2025-05-01T02:51:00.000Z | 2026-07-13T11:33:00.000Z | - |
| 020 IPC - Fill Weight Check | completed | 2026-05-01T16:20:00.000Z | 2025-01-10T00:25:00.000Z | Completed as per SOP |
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010567 | Hydrochloric Acid 37% Variant 8 | approved | Open workbench |
| LOT-010568 | Sodium Hydroxide Variant 8 | approved | Open workbench |
| LOT-010569 | Phosphoric Acid Variant 8 | approved | Open workbench |
| LOT-010570 | Active Pharmaceutical Ingredient A Variant 9 | quarantine | Open workbench |
| LOT-010571 | Active Pharmaceutical Ingredient B Variant 9 | hold | Open workbench |
| LOT-010572 | Active Pharmaceutical Ingredient C Variant 9 | rejected | Open workbench |
| LOT-010573 | Microcrystalline Cellulose Variant 9 | expired | Open workbench |
| LOT-010574 | Lactose Monohydrate Variant 9 | consumed | Open workbench |
| LOT-010575 | Hydroxypropyl Methylcellulose Variant 9 | in-process | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01378 Particle Size Analyzer #379 | operational | 2024-07-06 | requalification-due |
| AST-01379 Microscope #380 | operational | 2025-05-06 | not-qualified |
| AST-01380 Laminar Flow Cabinet #381 | operational | 2024-09-07 | qualified |
| AST-01381 Isolator #382 | in-calibration | 2026-05-05 | qualified |
| AST-01382 WFI Still #383 | in-maintenance | 2024-08-18 | qualified |
| AST-01383 RO System #384 | out-of-service | 2025-04-03 | requalification-due |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|---|---|---|
| Line Clearance Check | 101 | 96 to 106 | Pass / Pending review |
| API Weighing | 102 | 97 to 108 | Pass / Pending review |
| IPC - Loss on Drying | 100 | 97 to 108 | Pass / Pending review |
| Blending Time Verification | 103 | 94 to 102 | Pass / Pending review |
| IPC - Tablet Hardness | 102 | 98 to 108 | Pass / Pending review |
| IPC - Tablet Dissolution | 103 | 90 to 110 | Pass / Pending review |
| Filling Setup | 100 | 94 to 109 | Pass / Pending review |
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| System Error | major | closed | Not linked |
| System Error | major | closed | dev-01064 |
| System Error | major | closed | Not linked |
| System Error | major | closed | Not linked |
| System Error | major | closed | Not linked |
| System Error | major | closed | 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-020063
Score: 84
EBR completionOpen
Exceptions closedComplete
QC approvedComplete
Deviations dispositionedComplete
Calibration compliantComplete
Training confirmedComplete
Release review in progress - minor items pending.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.