Dashboard / ZBL-2026-001
ZBL-2026-001
Metformin HCl 500mg Tablets · Mfg Mar 2026 · Exp Feb 2028
AR NumberAR-2026-MET-001· batch-level spine, constant across every stage
Batch Health
Overall Status
RELEASED
Open Deviations
0
Closed Deviations
1
CAPA Pending Review
1
IPC Pass Rate
11 / 12
QC Pass Rate
13 / 13
Audit Readiness
96%
Batch Yield
99.6%
Last Activity
28-Mar-2026
Batch Relationships
ProductMetformin HCl 500mg Tablets
Brand OwnerSunshine Pharma Pvt Ltd
DeviationDEV-2026-014 — CLOSED
CAPACAPA-2026-008 — PENDING REVIEW
COAFinished Product COA (FPCOA-ZBL001) — PASS
Release CertificateBRL-ZBL001 — RELEASED
DEV-2026-014 · Linked Trace
- · Associated batch: ZBL-2026-001
- · Associated IPC failure: Hardness 7.1 kP at Compression — Start
- · Associated CAPA: CAPA-2026-008 — PENDING REVIEW (due 15-Apr-2026)
| Document ID | Record | Owner | Date | Status | Upload |
|---|---|---|---|---|---|
| BMR-MET-500-v3 | BMR — Processing Section Granulation recorded contemporaneously · Shift Day · Operator Ravi K. | Manufacturing | 19-Mar-2026 | COMPLETE | |
| EQL-GR-02 | Equipment Logbook — Granulator Granulator GR-02 · Previous batch cleaned 17-Mar · Cross-ref with BMR | Manufacturing | 19-Mar-2026 | COMPLETE | |
| ECR-GR-02 | Equipment Cleaning Record Granulator GR-02 cleaned per SOP-MFG-012 | Manufacturing | 17-Mar-2026 | COMPLETE | |
| IPC-2026-MET-001 | IPC Record — Granulation Moisture 2.1% (Spec 1.5–3.0%) · LOD PASS | QC | 19-Mar-2026 | PASS | |
| IPC-2026-MET-002 | IPC Record — Compression Hardness 8.2 kP · Friability 0.4% · Disintegration 4 min — all within spec after adjustment | QC | 20-Mar-2026 | PASS | |
| EM-MFG-2026-076 | Environmental Monitoring Temp 22°C · RH 45% · DP −5 Pa · all normal | QA | 19-Mar-2026 | COMPLETE | |
| DEV-2026-014 | Process Deviation Report Minor: Compression speed reduced at 10:30 — low hardness (7.1 kP) DEV-2026-014 — investigated, CAPA-2026-008 raised, batch continued | QA | 20-Mar-2026 | CLOSED | |
| TR-HR-2026-041 | Operator Training Records All 3 operators trained on SOP-MFG-012 — valid till Dec 2026 | HR / QA | 19-Mar-2026 | COMPLETE |
QC sign-off — Finished Product Testing · governed by SOP-QC-009
Select an analyst to run training check for SOP-QC-009.