Golden Batch Analyser
Compare any batch against the Golden standard.
- Batch ID
- MET-0889
- Dates
- 21 May 2026 → 24 May 2026
- Product
- Metformin HCl 500mg Tablets
- Operator
- Priya Sharma
- Equipment
- Line 1 · Compression
- Yield
- 96.5%
- OOS Count
- 0
- Deviation Count
- 0
- Cycle Time
- 4 days
- Total Checks
- 14 (all PASS)
- Cpk (Fill Weight)
- 1.95
- Quality Score
- 100/100
- Batch ID
- MET-0891
- Dates
- 01 Jun 2026 → 04 Jun 2026
- Product
- Metformin HCl 500mg Tablets
- Operator
- Priya Sharma
- Equipment
- Line 1 · Compression
- Yield
- 97.6%+1.1%GREEN
- OOS Count
- 1+1RED
- Deviation Count
- 1+1RED
- Cycle Time
- 4 days0 dGREEN
- Total Checks
- 7 (6 PASS, 1 OOS)0RED
- Cpk (Fill Weight)
- 0.36-1.6GREEN
- Quality Score
- 85/100-15RED
| Parameter | Spec | Golden Avg | MET-0891 Avg | Δ Diff | RAG |
|---|---|---|---|---|---|
| Fill Weight | 490–510 mg | 501.5mg | 497.7mg | -3.8mg | AMBER |
| Hardness | 8–12 kP | 9.2kP | 9.13kP | -0.07kP | GREEN |
| Friability | <1% | 0.6% | 0.55% | -0.05% | AMBER |
| Thickness | 7.9–8.3 mm | 8.1mm | 8.09mm | -0.01mm | GREEN |
| Disintegration | <15 min | 12.3min | 12.19min | -0.11min | GREEN |
| Parameter | Spec | Golden Avg | MET-0891 Avg | Δ Diff | RAG |
|---|---|---|---|---|---|
| Weight Gain | 3–5% | 4.1% | 4.07% | -0.03% | GREEN |
| Pan Temp | 45–55 °C | 50°C | 49.86°C | -0.14°C | GREEN |
| Parameter | Spec | Golden Avg | MET-0891 Avg | Δ Diff | RAG |
|---|---|---|---|---|---|
| Tablet Count | 10 tabs | 10 | 10 | 0 | GREEN |
| Seal Integrity | Intact | 100% | 100% | 0% | GREEN |
| Print Quality | Legible | 100% | 100% | 0% | GREEN |
| Foil Integrity | No damage | 100% | 100% | 0% | GREEN |
Compare value spread against spec window.
🟠 MET-0891 shows wider distribution (±7.2 mg) vs Golden (±0 mg). One or more readings fell outside spec (1 OOS event).
Auto-generated analysis based on comparison to Golden Batch MET-0889.
What: MET-0891 had 1 OOS event(s). Golden MET-0889 had zero OOS across all checks.
Why: Calibration drift on the compression machine likely caused compression force reduction between scheduled checks.
Action: ⚡ Tighten machine calibration interval and verify load cell zero before each batch.
What: Std deviation: ±7.2 mg vs Golden ±0 mg. Wider distribution increases OOS risk.
Why: Less frequent in-process sampling allowed drift to accumulate between checks.
Action: ⚡ Increase compression check frequency to every 60 minutes.
What: MET-0891 Cpk: 0.36 vs Golden Cpk: 1.95.
Why: Correlated with higher variation. Equipment calibration and check frequency are likely contributors.
Action: ⚡ Monitor Cpk trend. If Cpk drops below 1.33, raise CAPA immediately.
What: MET-0891 yield: 97.6% (1.1% vs Golden 96.5%).
Why: Improved raw material consistency or operator technique.
Action: ✅ Document this batch's practices for future reference.
What: All Coating and Packing parameters within Golden envelope. Packing achieved 100/100.
Why: No changes to coating or packing equipment or procedures.
Action: ✅ Maintain current Coating and Packing practices.
Key issue: Fill Weight OOS
All parameters within Golden envelope
All checks PASS
| Rank | Batch ID | Date Range | Pass % | OOS | Cycle | Score | RAG | Action |
|---|---|---|---|---|---|---|---|---|
| 1 | MET-0829 | 31 Jan 2026 → 02 Feb 2026 | 100% | 0 | 2 d | 100 | GREEN | |
| 2 | MET-0836 | 08 May 2026 → 10 May 2026 | 100% | 0 | 2 d | 100 | GREEN | |
| 3 | ⭐MET-0889GOLDEN | 21 May 2026 → 24 May 2026 | 100% | 0 | 4 d | 100 | GREEN | View |
| 4 | MET-0830 | 16 Feb 2026 → 18 Feb 2026 | 100% | 0 | 2 d | 97 | GREEN | |
| 5 | MET-0833 | 29 Mar 2026 → 31 Mar 2026 | 100% | 0 | 2 d | 97 | GREEN | |
| 6 | MET-0835 | 25 Apr 2026 → 27 Apr 2026 | 100% | 0 | 2 d | 97 | GREEN | |
| 7 | MET-0890 | 26 May 2026 → 29 May 2026 | 100% | 0 | 4 d | 94 | GREEN | |
| 8 | MET-0825 | 09 Dec 2025 → 11 Dec 2025 | 100% | 0 | 2 d | 94 | GREEN | |
| 9 | MET-0826 | 21 Dec 2025 → 23 Dec 2025 | 100% | 0 | 2 d | 94 | GREEN | |
| 10 | MET-0827 | 06 Jan 2026 → 08 Jan 2026 | 100% | 0 | 2 d | 94 | GREEN | |
| 11 | MET-0828 | 17 Jan 2026 → 19 Jan 2026 | 100% | 0 | 2 d | 94 | GREEN | |
| 12 | MET-0831 | 27 Feb 2026 → 01 Mar 2026 | 100% | 0 | 2 d | 94 | GREEN | |
| Fleet Avg | 100% | 0 | 2.3 d | 96.3 | ||||
