Batch BT-020321
Globustat • DRH • L022 • in-process
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
2025-01-03 → 2025-01-06
Actual
2024-08-10 → In progress
Exceptions
3
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010210 | Active Pharmaceutical Ingredient A Variant 7 | quarantine | Open workbench |
| LOT-010211 | Active Pharmaceutical Ingredient B Variant 7 | hold | Open workbench |
| LOT-010212 | Active Pharmaceutical Ingredient C Variant 7 | rejected | Open workbench |
| LOT-010213 | Microcrystalline Cellulose Variant 7 | expired | Open workbench |
| LOT-010214 | Lactose Monohydrate Variant 7 | consumed | Open workbench |
| LOT-010215 | Hydroxypropyl Methylcellulose Variant 7 | in-process | Open workbench |
| LOT-010216 | Magnesium Stearate Variant 7 | approved | Open workbench |
| LOT-010217 | Croscarmellose Sodium Variant 7 | approved | Open workbench |
| LOT-010218 | Povidone K30 Variant 7 | approved | Open workbench |
| LOT-010219 | Talc Variant 7 | quarantine | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01247 Centrifuge #248 | operational | 2026-02-10 | qualified |
| AST-01248 Lyophilizer #249 | in-calibration | 2025-07-10 | requalification-due |
| AST-01249 Filling Machine #250 | in-maintenance | 2025-03-23 | not-qualified |
| AST-01250 Visual Inspection System #251 | out-of-service | 2026-04-25 | qualified |
| AST-01251 Weighing Balance #252 | cleaning-required | 2025-07-12 | qualified |
| AST-01252 HPLC System #253 | operational | 2025-08-30 | qualified |
| AST-01253 UV-Vis Spectrophotometer #254 | operational | 2025-03-08 | requalification-due |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Missing Signature | major | under-review | dev-00322 |
| Missing Signature | major | under-review | dev-01322 |
| Missing Signature | major | under-review | Not linked |
| Missing Signature | major | under-review | Not linked |
| Missing Signature | major | under-review | Not linked |
| Missing Signature | major | under-review | dev-00822 |
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-020321
Score: 65
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.